Clinical trial NCT00977938: The Dual Antiplatelet Therapy Study (DAPT Study)
Official title: A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Acute Coronary Syndrome
Adverse event
Antiplatelet therapy
Sirolimus
Everolimus
Paclitaxel
Zotarolimus
Bare Metal Stent
Drug Eluting Stent
Clinical Events Committee
Dual antiplatelet therapy
Harvard Clinical Research Institute
Major Adverse Cardiac and Cerebral Event
Major Bleeding
Myocardial infarction
Myocardial ischemia
Percutaneous coronary intervention
Stent placement
Stent Thrombosis
Thienopyridine
Clopidogrel
Prasugrel
Lead sponsor: Baim Institute for Clinical Research
Sponsor class: OTHER
Collaborators: name: Abbott
name: Boston Scientific Corporation
name: Bristol-Myers Squibb
name: Sanofi-Synthelabo
name: Cordis Corporation
name: Eli Lilly and Company
name: Daiichi Sankyo
name: Medtronic
First posted: 2009-09-16
Enrollment: 25682
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

Detailed description: Subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass grafts undergoing percutaneous coronary intervention (PCI) with stent placement and no contraindications to prolonged dual antiplatelet therapy are eligible to be enrolled in the study.

All enrolled subjects will undergo PCI with stent placement. All enrolled subjects will be treated with either an FDA-approved drug eluting stent(s) (DES) or an FDA-approved bare metal stent(s) (BMS) (per their respective Instructions for Use) and assigned to 12 months of open label FDA-approved thienopyridine treatment in addition to aspirin. Operators will select the thienopyridine according to the package insert. Thienopyridine treatment dose will be according to the standard of practice and prescribing information for the selected medication. Aspirin treatment will be 75-325 mg for the first 6 months after the procedure and 75-162 mg subsequently, to be continued indefinitely. All DES or BMS subjects who are treated with 12 months of dual antiplatelet therapy post index procedure and who are event free per protocol will be eligible for randomization to either placebo (12 m DAPT Study arm) or an additional 18 months of thienopyridine treatment (30 m DAPT Study arm). Both arms will continue aspirin therapy.

Up to four (4) separate post-market approval studies will be allowed to incorporate the randomized design of the DAPT Study for a subset of subjects who may then be contributed for the DAPT Study analyses.

Eligibility criteria: Inclusion Criteria (Enrollment):

1. Subject is \> 18 years of age.
2. Subjects undergoing percutaneous intervention with stent deployment (or has w/in 24 hours).
3. Subjects without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation.
4. The subject has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form". The informed consent will be valid for the duration of the trial or until the subject withdraws.

Inclusion Criterion (Randomization at 12 months):

1. Subject, at 12 months, is free from death, MI, stroke, repeat coronary revascularization, major bleeding, and stent thrombosis and has been compliant with dual antiplatelet therapy following stent implantation.

Exclusion Criteria (Enrollment):

1. Index procedure stent placement with stent diameter \<2.25 mm or \>4.0 mm.
2. Pregnant women.
3. Planned surgery necessitating discontinuation of antiplatelet therapy within the 30 months following enrollment.
4. Current medical condition with a life expectancy of less than 3 years.
5. Concurrent enrollment in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a DES or BMS other than those included as DAPT Study devices. The subject may only be enrolled in the DAPT Study once.
6. Subjects on warfarin or similar anticoagulant therapy.
7. Subjects with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use for the device implanted.
8. Subjects unable to give informed consent.
9. Subject treated with both DES and BMS during the index procedure.

Exclusion Criteria (Randomization at 12 months):

1. Pregnant women.
2. Subject switched thienopyridine type or dose within 6 months prior to randomization.
3. Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
4. Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
5. Current medical condition with a life expectancy of less than 3 years.
6. Subjects on warfarin or similar anticoagulant therapy.

Primary outcomes:
measure: MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
timeFrame: 18 months (12-30 months post-index procedure)
measure: Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
timeFrame: 18 months (12-30 months post-index procedure)
measure: GUSTO Severe or Moderate Bleeding - Randomized DES ITT
timeFrame: 18 months (12-30 months post-index procedure)
Secondary outcomes:
measure: MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS
timeFrame: 33 months (0-33 months post-index procedure)
measure: Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS
timeFrame: 33 months (0-33 months post-index procedure)
measure: MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
timeFrame: 21 months (12-33 months post-index procedure)
measure: Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT
timeFrame: 21 months (12-33 months post-index procedure)
measure: GUSTO Severe or Moderate Bleeding - Randomized DES ITT
timeFrame: 21 months (12-33 months post-index procedure)
measure: MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
timeFrame: 18 months (12-30 months post-index procedure)
measure: Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
timeFrame: 18 months (12-30 months post-index procedure)
measure: GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
timeFrame: 18 months (12-30 months post-index procedure)
measure: MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT
timeFrame: 21 months (12-33 months post-index procedure)
measure: Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT
timeFrame: 21 months (12-33 months post-index procedure)
measure: GUSTO Severe or Moderate Bleeding - Randomized BMS ITT
timeFrame: 21 months (12-33 months post-index procedure)
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Heart & Vascular Center of Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Health Care
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas (Central VA) for Medical Science
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Fremont
country: United States
facility: California Cardiovascular Consultants/ Washington Hospital
state: California
city: La Jolla
country: United States
facility: The Foundation for Cardiovascular Medicine
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center- CA
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center / Vasek Polak Research Program
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Medical Center
state: California
city: Aurora
country: United States
facility: Medical Center of Aurora
state: Colorado
city: Bridgeport
country: United States
facility: Connecticut Clinical Research, LLC
state: Connecticut
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Stamford
country: United States
facility: St. Vincent's Medical Center
state: Connecticut
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: Palm Beach Heart Research Institute
state: Florida
city: Brandon
country: United States
facility: Bay Area Cardiology Associates/ Brandon Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Heart Center
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research
state: Florida
city: Lauderdale Lakes
country: United States
facility: Diagnostic Cardiology Associates
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Assoc
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Ocala
country: United States
facility: Ocala Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Hospital
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital Research Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Macon
country: United States
facility: Medical Center Central Georgia
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Hospital
state: Georgia
city: Barrington
country: United States
facility: Advocate Good Shephard Hospital
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Downers Grove
country: United States
facility: Good Samaritan Hospital- IL
state: Illinois
city: Elmhurst
country: United States
facility: Elmhurst Memorial Hospital
state: Illinois
city: Joliet
country: United States
facility: Heartland Education and Research Foundation
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Mokena
country: United States
facility: Heart Care Research Foundation
state: Illinois
city: Naperville
country: United States
facility: Edward Heart Hospital
state: Illinois
city: Elkhart
country: United States
facility: Midwest Cardiovascular Research and Education Foundation
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana, LLC
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Cardiovascular Physicians, P.C.
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic PC
state: Iowa
city: Cedar Rapids
country: United States
facility: St. Luke's Hospital - Cedar Rapids
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Ashland
country: United States
facility: Kings Daughters Medical Center
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Medical School
state: Louisiana
city: Bangor
country: United States
facility: Northeast Cardiology Associates
state: Maine
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital at Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Prince Frederick
country: United States
facility: Shah Associates, LLC
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Bay Regional Medical Center
state: Michigan
city: Detroit
country: United States
facility: Harper University Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital Heart & Vascular Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy-PTCMI
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: Saint Joseph
country: United States
facility: Great Lakes Heart & Vascular Institute, PC
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Troy
country: United States
facility: Beaumont Hospital Troy
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Saint Marys Hospital
state: Minnesota
city: Saint Cloud
country: United States
facility: Central Minnesota Heart Center at St. Cloud Hospital
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates Research LLC
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital Mid America Heart Institute
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Heart Foundation
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Springfield
country: United States
facility: St. John's Medical Institute
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health / Bergan Mercy Hospital
state: Nebraska
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley, PA
state: New Jersey
city: Hamilton
country: United States
facility: Hamilton Cardiology Associates
state: New Jersey
city: Hawthorne
country: United States
facility: Valley Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: Newark
country: United States
facility: St. Michaels Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Liverpool
country: United States
facility: SJH Cardiology Associates
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Utica
country: United States
facility: St. Elizabeth's Medical Center- NY
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Gastonia
country: United States
facility: Carolina Heart Specialists
state: North Carolina
city: High Point
country: United States
facility: Carolina Cardiology Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Association
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
city: Fargo
country: United States
facility: MeritCare Medical Center
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist
state: Ohio
city: Elyria
country: United States
facility: Elyria Memorial Hospital
state: Ohio
city: Marion
country: United States
facility: Frederick C Smith Clinic dba Smith Clinic
state: Ohio
city: Toledo
country: United States
facility: Northwest Ohio Cardiology
state: Ohio
city: Midwest City
country: United States
facility: Midwest Regional Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for CV Research
state: Oklahoma
city: Portland
country: United States
facility: St. Vincent Hospital/ Providence Heart Hospital
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Sciences University Hospital
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Chambersburg
country: United States
facility: Chambersburg Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Hospital
state: Pennsylvania
city: Johnstown
country: United States
facility: Conemaugh Memorial Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists
state: Pennsylvania
city: York
country: United States
facility: York Hospital (PA)
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Research- Rapid City Regional
state: South Dakota
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Heart - East Third Street
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Heart Institute
state: Tennessee
city: Nashville
country: United States
facility: Centennial Heart Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Austin
country: United States
facility: Capital Cardiovascular Research Institute
state: Texas
city: Austin
country: United States
facility: Texas Cardiovascular
state: Texas
city: Dallas
country: United States
facility: Veteran's Affairs Medical Center- Dallas
state: Texas
city: Dallas
country: United States
facility: CRSTI Research
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist DeBakey Heart & Vascular Center
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associate
state: Texas
city: Plano
country: United States
facility: The Heart Hospital / Baylor Plano
state: Texas
city: Round Rock
country: United States
facility: Scott and White Healthcare - Round Rock
state: Texas
city: San Antonio
country: United States
facility: TexSan Heart Hospital
state: Texas
city: Tyler
country: United States
facility: Mother Frances Hospital
state: Texas
city: Waco
country: United States
facility: Providence Healthcare Network
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Harrisonburg
country: United States
facility: Rockingham Memorial Hospital
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg General Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara, Norfolk General Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Virginia Beach
country: United States
facility: Cardiovascular Associates, Ltd.
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Olympia
country: United States
facility: Providence St. Peter Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Inland Cardiology Associates
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Wausau
country: United States
facility: CaRE Foundation, Inc.
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St. Vincents Hospital Sydney
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Eastern Heart
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Prahran
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: The Mount Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Clayton
country: Australia
facility: Monash Heart
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Karlovy Vary
country: Czechia
facility: Krajska karlovarska nemocnice a.s.
city: Kromeriz
country: Czechia
facility: Centrum pro choroby srdce a cev
city: Ostrava
country: Czechia
facility: Mestska nemocnice Ostrava
city: Zlin
country: Czechia
facility: Krajska nemocnice T. Bati a.s.
city: La Rochelle
country: France
facility: Centre Hospitalier Saint Louis
city: Lomme
country: France
facility: Hospital Saint Philibert
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nimes
country: France
facility: Clinique les Franciscaines
city: Paris
country: France
facility: Hopital Bichat
city: Pessac
country: France
facility: Groupe Hospitalier Sud
city: Tourcoing
country: France
facility: CH Chatiliez Tourcoing
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring
state: BE
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - PS
state: SH
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Berlin
country: Germany
facility: Vivantes-Klinikum Neukoelin
city: Berlin
country: Germany
facility: Vivantes-Klinikum Neukoelln
city: Berlin
country: Germany
facility: Vivantes-Humboldt Klinikum
city: Buxtehude
country: Germany
facility: Elbe-Kliniken Stade-Buxtehude GmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Stade
country: Germany
facility: Elbe-Kliniken Stade-Buxtehude GmbH
city: Budapest
country: Hungary
facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktato Korhaz Nonprofit Kft
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz
city: Epsom
country: New Zealand
facility: Mercy Angiography
state: Auckland
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Ascot Hospital
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Nelson
country: New Zealand
facility: Nelson Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Wellington
country: New Zealand
facility: Wakefield Hospital
city: Bialystok
country: Poland
facility: Uniwersyteck Szpital Klin. w Bialymstoku
city: Bydgoszcz
country: Poland
facility: Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ
city: Krakow
country: Poland
facility: NZOZ Centrum Medyczne Beluga-Med
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Szczecin
country: Poland
facility: SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie
city: Ustron
country: Poland
facility: Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S
city: Warszawa
country: Poland
facility: Instytut Kardiologii im. Kardynala St. Wyszynskiego
city: Bucuresti
country: Romania
facility: Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta Bucuresti
city: Bucuresti
country: Romania
facility: Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu
city: Bucuresti
country: Romania
facility: Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.
city: Bucuresti
country: Romania
facility: Spitalul Clinic Universitar de Urgenta Bucuresti
city: Cluj-Napoca
country: Romania
facility: Institutul Inimii Niculae Stancioiu Cluj-Napoca
city: Targu Mures
country: Romania
facility: Institutul de Boli Cardiovasculare si Transplant Targu Mures
city: High Wycombe
country: United Kingdom
facility: Wycombe General Hospital
state: Bucks
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
state: Cambs
city: Torquay
country: United Kingdom
facility: Torbay hospital
state: Devon
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital
state: Dorset
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: Essex
city: Barnet
country: United Kingdom
facility: Barnet Hospital
state: Herts
city: Middlesborough
country: United Kingdom
facility: James Cook Hospital
state: N York
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Weston Super Mare
country: United Kingdom
facility: Weston General Hospital
state: Somerset
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
state: Strath
city: Chertsey
country: United Kingdom
facility: St Peter's Hospital
city: Coventry
country: United Kingdom
facility: University Hospital of Coventry and Warwickshire
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Leicester
country: United Kingdom
facility: University Hospital of Leicester Glenfield Hospital
city: London
country: United Kingdom
facility: The London Chest Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Brigham and Women's Hospital
name: Laura Mauri, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Christ Hospital Heart and Vascular Center
name: Dean Kereiakes, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berg DD, Yeh RW, Mauri L, Morrow DA, Kereiakes DJ, Cutlip DE, Gao Q, Jarolim P, Michelson AD, Frelinger AL 3rd, Cange AL, Sabatine MS, O'Donoghue ML. Biomarkers of platelet activation and cardiovascular risk in the DAPT trial. J Thromb Thrombolysis. 2021 Apr;51(3):675-681. doi: 10.1007/s11239-020-02221-5.
citation: Stefanescu Schmidt AC, Steg PG, Yeh RW, Kereiakes DJ, Tanguay JF, Hsieh WH, Massaro JM, Mauri L, Cutlip DE; DAPT Investigators. Interruption of Dual Antiplatelet Therapy Within Six Months After Coronary Stents (from the Dual Antiplatelet Therapy Study). Am J Cardiol. 2019 Dec 15;124(12):1813-1820. doi: 10.1016/j.amjcard.2019.09.006. Epub 2019 Sep 26.
citation: Berry NC, Kereiakes DJ, Yeh RW, Steg PG, Cutlip DE, Jacobs AK, Abbott JD, Hsieh WH, Massaro JM, Mauri L; DAPT Study Investigators. Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e005308. doi: 10.1161/CIRCINTERVENTIONS.117.005308.
citation: Yeh RW, Kereiakes DJ, Steg PG, Cutlip DE, Croce KJ, Massaro JM, Mauri L; DAPT Study Investigators. Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Oct 31;70(18):2213-2223. doi: 10.1016/j.jacc.2017.09.011.
citation: Secemsky EA, Yeh RW, Kereiakes DJ, Cutlip DE, Cohen DJ, Steg PG, Cannon CP, Apruzzese PK, D'Agostino RB Sr, Massaro JM, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting: A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study. JAMA Cardiol. 2017 May 1;2(5):478-487. doi: 10.1001/jamacardio.2017.0063.
citation: Stefanescu Schmidt AC, Kereiakes DJ, Cutlip DE, Yeh RW, D'Agostino RB Sr, Massaro JM, Hsieh WH, Mauri L; DAPT Investigators. Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy). Circulation. 2017 May 2;135(18):1720-1732. doi: 10.1161/CIRCULATIONAHA.116.024835. Epub 2017 Feb 22.
citation: Resor CD, Nathan A, Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Gabriel Steg P, Hsieh WH, Mauri L; Dual Antiplatelet Therapy Study Investigators. Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. Circulation. 2016 Oct 4;134(14):989-998. doi: 10.1161/CIRCULATIONAHA.116.024531. Epub 2016 Aug 30.
citation: Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Steg PG, Wiviott SD, Mauri L; DAPT Study Investigators. DAPT Score Utility for Risk Prediction in Patients With or Without Previous Myocardial Infarction. J Am Coll Cardiol. 2016 May 31;67(21):2492-502. doi: 10.1016/j.jacc.2016.03.485. Epub 2016 Apr 1.
citation: Yeh RW, Secemsky EA, Kereiakes DJ, Normand SL, Gershlick AH, Cohen DJ, Spertus JA, Steg PG, Cutlip DE, Rinaldi MJ, Camenzind E, Wijns W, Apruzzese PK, Song Y, Massaro JM, Mauri L; DAPT Study Investigators. Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention. JAMA. 2016 Apr 26;315(16):1735-49. doi: 10.1001/jama.2016.3775.
citation: Meredith IT, Tanguay JF, Kereiakes DJ, Cutlip DE, Yeh RW, Garratt KN, Lee DP, Steg PG, Weaver WD, Holmes DR Jr, Brindis RG, Trebacz J, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Diabetes Mellitus and Prevention of Late Myocardial Infarction After Coronary Stenting in the Randomized Dual Antiplatelet Therapy Study. Circulation. 2016 May 3;133(18):1772-82. doi: 10.1161/CIRCULATIONAHA.115.016783. Epub 2016 Mar 18.
citation: Hermiller JB, Krucoff MW, Kereiakes DJ, Windecker S, Steg PG, Yeh RW, Cohen DJ, Cutlip DE, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents. JACC Cardiovasc Interv. 2016 Jan 25;9(2):138-47. doi: 10.1016/j.jcin.2015.10.001.
citation: Mauri L, Elmariah S, Yeh RW, Cutlip DE, Steg PG, Windecker S, Wiviott SD, Cohen DJ, Massaro JM, D'Agostino RB Sr, Braunwald E, Kereiakes DJ; DAPT Study Investigators. Causes of late mortality with dual antiplatelet therapy after coronary stents. Eur Heart J. 2016 Jan 21;37(4):378-85. doi: 10.1093/eurheartj/ehv614. Epub 2015 Nov 18.
citation: Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; DAPT Study Investigators. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy. JACC Cardiovasc Interv. 2015 Oct;8(12):1552-62. doi: 10.1016/j.jcin.2015.05.026.
citation: Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction. J Am Coll Cardiol. 2015 May 26;65(20):2211-21. doi: 10.1016/j.jacc.2015.03.003. Epub 2015 Mar 15.
citation: Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial. JAMA. 2015 Mar 17;313(11):1113-21. doi: 10.1001/jama.2015.1671.
citation: Yeh RW, Czarny MJ, Normand SL, Kereiakes DJ, Holmes DR Jr, Brindis RG, Weaver WD, Rumsfeld JS, Roe MT, Kim S, Driscoll-Shempp P, Mauri L. Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):96-102. doi: 10.1161/CIRCOUTCOMES.114.001239. Epub 2014 Nov 16.
citation: Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.
citation: Matteau A, Yeh RW, Kereiakes D, Orav EJ, Massaro J, Steg PG, Normand SL, Cutlip DE, Mauri L. Frequency of the use of low- versus high-dose aspirin in dual antiplatelet therapy after percutaneous coronary intervention (from the Dual Antiplatelet Therapy study). Am J Cardiol. 2014 Apr 1;113(7):1146-52. doi: 10.1016/j.amjcard.2013.10.015. Epub 2013 Nov 8.
citation: Mauri L, Kereiakes DJ, Normand SL, Wiviott SD, Cohen DJ, Holmes DR, Bangalore S, Cutlip DE, Pencina M, Massaro JM. Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions. Am Heart J. 2010 Dec;160(6):1035-41, 1041.e1. doi: 10.1016/j.ahj.2010.07.038.