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Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor

NCT02545933 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-09-16

Study results available
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Summary

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the standard of care for the long-term secondary prevention of atherothrombotic events in patients with myocardial infarction (MI). However, rates of ischemic recurrences remain high, which may be in part due to the fact that other platelet signaling pathways, such as thrombin-induced platelet aggregation, continue to be activated. Vorapaxar is a protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of thrombin-mediated platelet aggregation. It is approved for clinical use by the Food and Drug Administration for the reduction of thrombotic cardiovascular events in patients with a history of MI or with peripheral arterial disease. However, to date clinical trial experience with vorapaxar has been almost exclusively with the P2Y12 receptor inhibitor clopidogrel and the effects of vorapaxar in combination with antiplatelet therapy including prasugrel or ticagrelor, is largely unexplored. Further, the role of vorapaxar as part of a dual antithrombotic treatment regimen, in addition to a novel P2Y12 receptor inhibitor, with withdrawal of aspirin, represents another important area of clinical interest as it has the potential to maximize ischemic protection while reducing the risk of bleeding. The proposed prospective, randomized, parallel-design, open label, study conducted in a real world clinical setting of post-MI patients will aim to assess the pharmacodynamic effects of vorapaxar in addition to antiplatelet therapy with a novel P2Y12 receptor inhibitor (prasugrel or ticagrelor) with and without aspirin.

Conditions

Interventions

DRUG

Prasugrel

Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)

DRUG

Vorapaxar

Vorapaxar will be administered at the dose of 2.5mg once daily

DRUG

Aspirin

Aspirin will be administered at the dose of 81mg once daily

DRUG

Ticagrelor

Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)

Sponsors & Collaborators

Principal Investigators

  • Dominick J Angiolillo, MD, PhD · University of Florida College of Medicine-Jacksonville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-05-31
Completion
2020-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
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 NCT02545933 on ClinicalTrials.gov