Prasugrel Versus High Dose Clopidogrel in Patients With Stable Coronary Artery Disease and High Platelet Reactivity While on Chronic Clopidogrel Treatment

August 21, 2011 updated by: Dimitrios Alexopoulos, University of Patras
Clopidogrel administration is considered standard of care in patients with stable coronary artery disease post PCI. However , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. The hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the VerifyNow point of care assay. Clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at Day 14, when treatment crossover will be performed without a washout period. At Day 28 platelet reactivity will be assessed as well.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Patras, Greece, 26500
        • Dimitrios Alexopoulos
      • Patras, Greece, 26500
        • Patras University Hospital Cardiology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years old
  • Patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment
  • High on-clopidogrel platelet reactivity (≥235 Platelet Reactivity Units as assessed with the VerifyNow assay)
  • Written Informed Consent

Exclusion Criteria:

  • History of bleeding diathesis
  • History of active bleeding within 6 months before randomization
  • Chronic oral anticoagulation treatment
  • Contraindications to antiplatelet treatment
  • Known platelet function disorders
  • Acute coronary syndrome within 30 days before randomization
  • Cardiogenic shock
  • Planned Percutaneous Coronary Intervention in the next 30 days
  • Cancer
  • Haemodialysis
  • Platelet count < 100000/μL
  • Hematocrit < 30%
  • High likelihood of being unavailable on the Day 28 visit
  • History of stroke
  • Known allergy to clopidogrel and/or prasugrel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clopidogrel
Drug: Clopidogrel
Clopidogrel 150mg per day
Experimental: Prasugrel
Prasugrel 10mg per day
Drug: Prasugrel
Prasugrel 10mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Platelet Reactivity
Time Frame: At 14 and 28 days after randomization
Platelet reactivity in Platelet Reactivity Units (PRU) as assessed with the VerifyNow point of care assay will be measured at the end of the two treatment periods, namely at 14 and 28 days after randomization
At 14 and 28 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 21, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATRASCARDIOLOGY-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease (CAD)

Clinical Trials on Prasugrel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe