CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 110 enrolled
Drug / intervention
Prasugrel +1 moredrug
Likely dose
Prasugrel 10 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/NCT01260584
NCT01260584Phase 4Completed

The Influence of Smoking Status on the Pharmacokinetics and Pharmacodynamics of Prasugrel and Clopidogrel in Aspirin-treated Subjects With Stable Coronary Artery Disease

Daiichi Sankyo·interventional·Posted Dec 15, 2010·Updated Jan 9, 2019

In Brief

A Phase 4 clinical trial evaluating Prasugrel and Clopidogrel for Coronary Artery Disease. Completed, enrolled 110 participants across 3 sites.

Detailed Summary

This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites of clopidogrel. The primary hypothesis is that smoking status will influence the antiplatelet effects and active metabolite concentrations of clopidogrel but will have no impact on prasugrel's antiplatelet effects or active metabolite concentrations.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2010
Enrollment StartNov 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.5 years ago

Interventions

Prasugreldrug

One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.

Clopidogreldrug

One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.