CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Prasugrel +1 moredrug
Likely dose
Clopidogrel 600 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/NCT01789814
NCT01789814Phase 4Completed

The Effect of Prasugrel as Compared to Clopidogrel on Platelet Function Immediately Following the Termination of Intravenous Bivalirudin in Patients Undergoing Percutaneous Coronary and Structural Cardiac Intervention

Tufts Medical Center·interventional·Posted Feb 12, 2013·Updated Apr 4, 2017

In Brief

A Phase 4 clinical trial evaluating Prasugrel and Clopidogrel for Coronary Artery Disease. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Early stent thrombosis has been noted with increased frequency in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) who are treated with bivalirudin and clopidogrel. The brief half life of bivalirudin acting in concert with the delayed action of clopidogrel likely exposes patients to thrombosis during a vulnerable period of reduced antiplatelet effect in the immediate post stenting period. Combination therapy with bivalirudin and prasugrel is conceptually attractive as the more rapid onset of action of prasugrel could potentially significantly diminish the vulnerable period, likely reducing the potential for acute stent thrombosis. The trials which have documented the efficacy of prasugrel as compared to clopidogrel have, in general, not reported on patients in whom bivalirudin was utilized. Currently, in the United States, bivalirudin is the most commonly used adjunctive agent used during PCI. Using light transmission aggregometry, this study will examine the inhibition of platelet aggregation in patients randomized to treatment with clopidogrel vs prasugrel during the vulnerable period following the discontinuation of bivalirudin therapy. The investigators anticipate that this study will document significant enhancement of inhibition of platelet aggregation in patients randomized to prasugrel treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2013
Enrollment StartJul 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.4 years ago

Interventions

Prasugreldrug

Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy.

Clopidogreldrug

Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter