At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 16 enrolled

Drug / intervention

Vorapaxar +2 moredrug

Likely dose

Vorapaxar 10mgfrom 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/NCT02875028

NCT02875028Phase 4Completed

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Vorapaxar in the Human Endotoxemia Model A Randomized, Double-Blind, Crossover Study

Medical University of Vienna·interventional·Posted Aug 23, 2016·Updated Jan 10, 2020

In Brief

A Phase 4 clinical trial evaluating Vorapaxar, Placebo, and 1 other intervention for Healthy Volunteers. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet inhibition may also exert positive results on coagulation activation and may beneficially influence the inflammatory response. Since vorapaxar is the first available substance of a new class of platelet inhibitors its effects on the human coagulation system and the inflammatory response will be assessed in the well-established human endotoxemia model.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy Volunteers

CountriesAustria

Collaborators--

Timeline

Phase 4CompletedFinished

2017201820192020202120222023202420252026

Enrollment StartJun 2016

First PostedAug 2016

Primary CompletionNov 2016

TodayJul 2026

First PostedAug 23, 2016

Enrollment StartJun 1, 2016

Primary CompletionNov 30, 2016

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 9.9 years ago

Interventions

Vorapaxardrug

10mg-20mg vorapaxar to achieve \>80% thrombin-receptor activated peptide-6 (TRAP) induced platelet inhibition

Placebodrug

LPSother

2ng/kg Lipopolysaccharide as a bolus infusion