Clinical trial NCT02240810: PLATINUM Diversity
Official title: PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 1501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population will be selected from clinical locations where subjects are treated with at least one Promus PREMIER everolimus-eluting coronary stent.

Brief summary: To compile acute procedural performance and clinical outcomes data for the Promus PREMIER everolimus-eluting coronary stent system in understudied/underserved patient populations including women and minorities.


Eligibility criteria: Inclusion Criteria:

* Patient must be at least 18 years of age
* Patient must sign informed consent form
* Patient has received at least one Promus PREMIER stent
* Patient self-identifies as one or more of the following:

  * Female
  * Black of African Heritage
  * Hispanic/Latino
  * American Indian or Alaska native

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Secondary outcomes:
measure: Death
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: Myocardial Infarction (MI)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
measure: Target Vessel Revascularization (TVR)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St Luke's Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: St Bernards Heart and Vascular
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Cardiology/Baptist Health Medical Center
state: Arkansas
city: Bakersfield
country: United States
facility: Central Cardiology Medical Clinic
state: California
city: Chula Vista
country: United States
facility: Sharp Chula Vista Medical Center
state: California
city: Fresno
country: United States
facility: Cardiovascular Consultants Heart Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Washington
country: United States
facility: Capital Research Institute
state: District of Columbia
city: Brandon
country: United States
facility: Bay Area Cardiology
state: Florida
city: Hollywood
country: United States
facility: Research Physicians Network Alliance
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart & Vascular
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: University Hospital
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Joliet
country: United States
facility: Presence Saint Joseph Medical Center
state: Illinois
city: Merrillville
country: United States
facility: The Heart Center of Lake County
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Shreveport
country: United States
facility: Cardiovascular Research, LLC (Willis-Knighton)
state: Louisiana
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Gulfport
country: United States
facility: CCA Research
state: Mississippi
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: Presbyterian University Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health
state: South Carolina
city: Greenville
country: United States
facility: St. Francis Physician Services Inc., DBA Upstate Cardiology
state: South Carolina
city: Austin
country: United States
facility: Seton Heart Institute
state: Texas
city: Dallas
country: United States
facility: Methodist Hospital Dallas
state: Texas
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Forth Worth
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: New Braunfels
country: United States
facility: Christus Santa Rosa Hospital-City Center
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
city: Tacoma
country: United States
facility: Cardiac Study Center
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Roxana Mehran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tallahassee Memorial Hospital
name: Wayne Batchelor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Batchelor W, Kandzari DE, Davis S, Tami L, Wang JC, Othman I, Gigliotti OS, Haghighat A, Singh S, Lopez M, Giugliano G, Horwitz PA, Chandrasekhar J, Underwood P, Thompson CA, Mehran R. Outcomes in Women and Minorities Compared With White Men 1 Year After Everolimus-Eluting Stent Implantation: Insights and Results From the PLATINUM Diversity and PROMUS Element Plus Post-Approval Study Pooled Analysis. JAMA Cardiol. 2017 Dec 1;2(12):1303-1313. doi: 10.1001/jamacardio.2017.3802.
citation: Batchelor WB, Damluji AA, Yong C, Fiuzat M, Barnett SD, Kandzari DE, Sherwood MW, Epps KC, Tehrani BN, Allocco DJ, Meredith IT, Lindenfeld J, O'Connor CM, Mehran R. Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries. Am Heart J. 2021 Jun;236:37-48. doi: 10.1016/j.ahj.2021.02.003. Epub 2021 Feb 24.
citation: Mehran R, Chandrasekhar J, Davis S, Nathan S, Hill R, Hearne S, Vismara V, Pyo R, Gharib E, Hawa Z, Chrysant G, Kandzari D, Underwood P, Allocco DJ, Batchelor W. Impact of Race and Ethnicity on the Clinical and Angiographic Characteristics, Social Determinants of Health, and 1-Year Outcomes After Everolimus-Eluting Coronary Stent Procedures in Women. Circ Cardiovasc Interv. 2019 Apr;12(4):e006918. doi: 10.1161/CIRCINTERVENTIONS.118.006918.