CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,530 enrolled
Drug / intervention
Aspirin +3 moredrug
Likely dose
Aspirin 325 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00823212
NCT00823212Phase 3Completed
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PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions

Boston Scientific Corporation·interventional·Posted Jan 15, 2009·Updated Mar 27, 2019

In Brief

A Phase 3 clinical trial evaluating PROMUS Coronary Stent System, PROMUS Element Coronary Stent System, and 2 other interventions for Coronary Artery Disease. Completed, enrolled 1,530 participants across 133 sites in 17 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesAustralia, Austria, Belgium, Denmark, Finland, France, Germany, Japan, Latvia, Malaysia, Netherlands, New Zealand, Poland, Portugal, Singapore, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2009
Enrollment StartJan 1, 2009
Primary CompletionSep 1, 2010
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.5 years ago

Interventions

PROMUS Coronary Stent Systemdevice

PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).

PROMUS Element Coronary Stent Systemdevice

PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS \[XIENCE V\] stent).

Aspirindrug

Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.

Thienopyridinedrug

Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.