Clinical trial NCT00645918: GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety
Official title: GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Acute Coronary Syndrome
Keywords: Platelets
Platelet Function Tests
Clopidogrel
Drug Eluting Stents
Acute Coronary Syndrome
Myocardial Ischemia
Stent Thrombosis
Heart Diseases
Coronary Disease
Arterial Occlusive Disease
Lead sponsor: Accumetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 2800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after drug-eluting stent implantation.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 years or older.
* 2. Patients undergoing coronary angiography and possible PCI with planned use of at least one drug-eluting stent (DES), and without planned use of glycoprotein IIb/IIIa inhibitors. One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting, as long as at least one DES is implanted. However, the procedure must be successful and uncomplicated for all lesions (DES + BMS + non stent).
* Indication for the procedure may be stable angina or ischemia, unstable angina, non-ST elevation MI (NSTEMI), or ST elevation MI (STEMI).
* Have the ability to understand the requirements of the study, including consent for use and disclosure of research-related health information.
* Have the ability to comply with study procedures and protocol, including required study visits.
* 6. A female patient is eligible to enter the study if she is (1) of child-bearing potential and not pregnant or nursing; (2) not of child-bearing potential (i.e., has had a hysterectomy, have both ovaries removed, has tubal ligation, or are post-menopausal, defined as 24 months without menses).

Exclusion Criteria: Pre-PCI

* PCI within previous 30 days.
* Prior consent to participate in GRAVITAS and not randomized by IVRS.
* History of gastro-intestinal bleeding within 6 months.
* Major non-cardiac surgery within 6 weeks.
* Ischemic stroke within 6 weeks.
* Any history of hemorrhagic stroke or sub-arachnoid hemorrhage.
* Other bleeding diathesis, or considered by investigator to be at high-risk for bleeding on long-term clopidogrel therapy.
* Minor surgical procedures that require cessation of dual anti platelet therapy and result in significant bleeding are NOT eligible.
* Current or planned therapy with coumadin anticoagulation.
* Current or planned therapy with other thienopyridine class of ADP receptor inhibitors (e.g., prasugrel, ticlopidine), or the non-thienopyridine ticagrelor.
* Severe allergy to stainless steel, contrast dye, unfractionated heparin, low molecular weight heparin, or bivalirudin that cannot be adequately pre-medicated.
* Allergy to aspirin or clopidogrel.
* Current enrollment in an investigational drug or device study that has not reached the time period of the primary endpoint.
* Have received GPIIb/IIIa inhibitors eptifibatide or tirofiban within 24 hours before or during PCI or abciximab within 10 days before or during PCI.
* Thrombocytopenia (defined as platelet count \< 100 K).
* Anemia (hematocrit \< 30%).
* Polycythemia (hematocrit \> 52%).
* Patients unwilling or unable to complete clinical follow-up for the duration of the study.

Exclusion Criteria: Post-PCI

* PCI with placement of at least one DES is not performed.
* Planned staged PCI in the next 6 months post-procedure.
* Unsuccessful PCI (post-procedure diameter stenosis \>30% with less than TIMI-3 flow in any treated vessel).
* Patients with in-hospital STEMI confirmed by ECG prior to randomization or those whom require a target vessel revascularization of the index lesion prior to randomization.
* Patients with acute stent thrombosis before Accumetrics VerifyNow tests.
* Administration of any GPIIb/IIIa during PCI procedure or prior to initial hospital discharge.
* Failure to meet clopidogrel requirements
* Major complication during or after PCI

Primary outcomes:
measure: Time to first occurrence of post-randomization CV death, non-fatal MI, or ARC definite/probable stent thrombosis in non-responders randomized to standard vs. tailored dosage
timeFrame: 6 months
Secondary outcomes:
measure: Time to first occurrence of post-randomization CV death, non-fatal MI, or ARC definite/probable stent thrombosis in non-responders randomized to standard dosage vs. responders
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Health Care - Osborn Campus
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Health Care - Shea Campus
state: Arizona
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Sacramento Heart and Vascular Research Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: San Diego
country: United States
facility: Alvarado Hospital
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Moffitt-Long Hospital
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Hospital
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Clearwater Cardiovascular and Interventional Consultants
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Ormond Beach
country: United States
facility: Cardiology Research Associates
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Research Institute
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Medical Center
state: Illinois
city: Moline
country: United States
facility: Trinity Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana/The Care Group LLC
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: The Lahey Clinic
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Petoskey
country: United States
facility: Cardiac and Vascular Research Center of Northern Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph's Mercy Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Health System
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's / Mid America Heart Institute
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: NY Presbyterian / Weill Cornell Medical Center
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: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: High Point
country: United States
facility: Carolina Cardiology Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research, Ltd.
state: Ohio
city: Fairview Park
country: United States
facility: Cleveland Cardiovascular Research Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Associates
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Clinic - Cardiology
state: Pennsylvania
city: Erie
country: United States
facility: St. Vincent Health Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Clinical Research Center
state: South Dakota
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: South Austin Hospital
state: Texas
city: Austin
country: United States
facility: Austin Heart P.A.
state: Texas
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: University Hospital San Antonio (UTHSCSA)
state: Texas
city: Tomball
country: United States
facility: Tomball Regional Hospital
state: Texas
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Newmarket
country: Canada
facility: York PCI Group
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel-Dieu
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Montréal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Québec
country: Canada
facility: Hôpital Laval
state: Quebec
Study officials:
affiliation: Scripps Advanced Clnical Trials
name: Matthew J Price, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price MJ, Angiolillo DJ, Teirstein PS, Lillie E, Manoukian SV, Berger PB, Tanguay JF, Cannon CP, Topol EJ. Platelet reactivity and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent analysis of the Gauging Responsiveness with a VerifyNow P2Y12 assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Circulation. 2011 Sep 6;124(10):1132-7. doi: 10.1161/CIRCULATIONAHA.111.029165. Epub 2011 Aug 29.
citation: Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290.
citation: Price MJ, Berger PB, Angiolillo DJ, Teirstein PS, Tanguay JF, Kandzari DE, Cannon CP, Topol EJ. Evaluation of individualized clopidogrel therapy after drug-eluting stent implantation in patients with high residual platelet reactivity: design and rationale of the GRAVITAS trial. Am Heart J. 2009 May;157(5):818-24, 824.e1. doi: 10.1016/j.ahj.2009.02.012.