PLATINUM Diversity

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)

ClinicalTrials.gov ID

NCT02240810

Acronym / sponsor ID

S2326

Conditions

Atherosclerosis, Coronary Artery Disease

Study type

Observational

Recruitment status

Completed

Enrolment

1,501 participants (actual)

Lead sponsor

Boston Scientific CorporationIndustry (pharma, biotech, devices)

Study start

Oct 2014 (actual)

Primary completion

Sep 2016 (actual)

Study completion

Dec 2016 (actual)

First posted

16 Sep 2014 (estimated)

Results

Posted 10 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

12 Months

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Population will be selected from clinical locations where subjects are treated with at least one Promus PREMIER everolimus-eluting coronary stent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)

   Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months

   A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Background: PubMed 29049508Batchelor 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.
• Derived from this study: PubMed 38469035Epps K, Goel R, Mehran R, Kandzari D, Damluji A, Tehrani B, Sherwood M, Truesdell A, Davis S, Wang JC, Lopez M, Singh S, Underwood P, Allocco D, Batchelor W. Influence of Race/Ethnicity and Sex on Coronary Stent Outcomes in Diabetic Patients. J Soc Cardiovasc Angiogr Interv. 2023 Sep-Oct;2(5):101053. doi: 10.1016/j.jscai.2023.101053. Epub 2023 Aug 4.
• Derived from this study: PubMed 37354778Beerkens FJ, Cao D, Batchelor W, Sartori S, Kandzari DE, Davis S, Tamis L, Wang JC, Othman I, Vogel B, Spirito A, Subramaniam V, Gigliotti OS, Haghighat A, Feng Y, Singh S, Lopez M, Giugliano G, Horwitz PA, Dangas G, Mehran R. Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries). Am J Cardiol. 2023 Aug 1;200:204-211. doi: 10.1016/j.amjcard.2023.05.028. Epub 2023 Jun 22.
• Derived from this study: PubMed 33636137Batchelor 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.
• Derived from this study: PubMed 30998393Mehran 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

52 sites in 1 country: see every site and its status.