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Vorapaxar on Thrombin Generation and Coagulability

NCT03207451 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2022-08-18

Study results available
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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.

Conditions

Interventions

DRUG

Vorapaxar

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

DRUG

Vorapaxar and Aspirin

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

DRUG

Vorapaxar and Clopidogrel

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

DRUG

Vorapaxar, Aspirin, and Clopidogrel

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

Sponsors & Collaborators

Principal Investigators

  • Paul Gurbel, MD · Inova Health Care Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2018-07-01
Completion
2018-08-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207451 on ClinicalTrials.gov