CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
Aspirindrug
Likely dose
Aspirin 100 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/NCT02049762
NCT02049762Phase 4Completed

Aspirin Impact on Platelet Reactivity in Acute Coronary Syndrome Patients on Novel P2Y12 Inhibitors Therapy

Sheba Medical Center·interventional·Posted Jan 30, 2014·Updated Feb 22, 2018

In Brief

A Phase 4 clinical trial evaluating Aspirin for Acute Coronary Syndrome and 2 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed Summary

Thus far, no study has evaluated the impact on aspirin in addition to the newer and more potent P2Y12 inhibitors, among ACS patients and current guidelines recommend dual anti-platelet therapy consisting of aspirin and a novel P2Y12 inhibitor in this population. Objective The investigators goal is to examine the effect of aspirin in addition to new anti-platelet agent (ticagrelor\\prasugrel) on platelet reactivity in comparison with placebo, among ACS patients treated percutaneously. Design The proposed study is a randomized-controlled, double blind trial, conducted among ACS patients treated percutaneously. Eligible patients will recruited during hospitalization due to ACS after percutaneous coronary intervention (PCI), and randomization by envelopes on 1:1 basis will take place a month after the index event, at a follow-up visit at the cardiac clinic. Platelet function and Endothelial function tests will be taken a month after the index event, and at a 2 weeks periods following aspirin/placebo therapy, cross-over and return to open-label aspirin. End-points platelet function tests will be compared between aspirin and placebo therapy and before and after the cross-over.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 30, 2014
Enrollment StartJun 1, 2015
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.4 years ago

Interventions

Aspirindrug

Aspirin 100 mg vs. placebo in ACS patients on P2Y12 inhibitors a month following PCI.