Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

August 23, 2010 updated by: University of Patras

Phase 3 Study of Prasugrel vs High Dose (150 mg) Clopidogrel in Clopidogrel Resistant Patients Post Coronary Angioplasty.

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

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
      • Rio, Patras, Greece, 26500
        • Cardiology Department, Patras University Hospital

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years old
  • Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
  • Written Informed consent
  • Platelet reactivity units (PRU) (VerifyNow) >230

Exclusion Criteria:

  • A history of bleeding diathesis
  • Chronic oral anticoagulation treatment
  • Contraindications to antiplatelet therapy
  • Known platelet function disorders
  • PCI or coronary artery bypass surgery < 3 months
  • Unsuccessful PCI (residual stenosis > 30% or flow < Thrombolysis in myocardial infarction flow 3)
  • Planned staged PCI in the next 60 days
  • Hemodynamic instability
  • Cancer or hemodialysis
  • Platelet count <100 000/ μL, hematocrit <30%
  • Creatinine clearance <25 ml/min
  • A life expectancy<1 year, inability to give informed consent
  • High likelihood of being unavailable for the Day 60 follow up

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: prasugrel
prasugrel per os 10mg/day
Drug: prasugrel
prasugrel 10 mg/day
ACTIVE_COMPARATOR: clopidogrel
clopidogrel per os 150mg/day
Drug: clopidogrel
clopidogrel per os 150mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Platelet Reactivity Units (PRU) assessed by VerifyNow P2Y12(Accumetrics)
Time Frame: Day 60
Day 60

Collaborators and Investigators

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

Sponsor

University of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

April 22, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (ESTIMATE)

April 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2010

Last Update Submitted That Met QC Criteria

August 23, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATRASCARDIOLOGY-1

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.

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