CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Vorapaxar +3 moredrug
Likely dose
Not stated in 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/NCT03207451
NCT03207451Phase 4Completed

Influence of Vorapaxar on Thrombin Generation and Coagulability

Inova Health Care Services·interventional·Posted Jul 2, 2017·Updated Aug 18, 2022

In Brief

A Phase 4 clinical trial evaluating Vorapaxar, Vorapaxar and Aspirin, and 2 other interventions for Coronary Artery Disease and 2 related conditions. Completed, enrolled 81 participants across 1 site.

Detailed Summary

This investigation will be conducted in patients 18-75 years of age with multiple coronary artery disease risk factors (antiplatelet naïve patients) and patients with prior MI or PVD on antiplatelet therapy. Pharmacodynamics will be assessed at multiple time points to assess onset-, maintenance-, and offset-effect of vorapaxar on thrombin generation, platelet reactivity, and plasma/platelet endothelial and inflammatory biomarkers. Safety assessment will be assessed throughout the study.

Study Details

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

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartJan 1, 2016
Primary CompletionJul 1, 2018
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9 years ago

Interventions

Vorapaxardrug

Vorapaxar is the principle study drug and will be given to all subjects.

Vorapaxar and Aspirindrug

Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.

Vorapaxar and Clopidogreldrug

Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.

Vorapaxar, Aspirin, and Clopidogreldrug

Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.