Plavix, Prasugrel and Drug Eluting Stents Pilot Trial (PPD)

April 14, 2010 updated by: St. Francis Hospital, New York

PPD Trial Pilot Study: Plavix, Prasugrel and Drug Eluting Stents

  • The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation.
  • In subjects with high residual levels of platelet reactivity after receiving either a maintenance or loading dose of either clopidogrel or prasugrel, a cross over of thienopyridine treatment to the alternate medication will occur.
  • The study tests the hypothesis that adequate platelet inhibition will occur in subjects who have high levels of platelet reactivity and are subsequently switched from clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention (PCI).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

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

  • United States
    • New York
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard A Shlofmitz, MD

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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject presenting for clinically indicated PCI with implantation of at least one drug-eluting stent.
  • No planned use of Glycoprotein IIb/IIIa inhibitors during PCI procedure.
  • Subject must be taking aspirin or enteric coated aspirin 81 mg-325 mg daily.
  • Willing to participate and sign an informed consent.

Exclusion Criteria:

  • Subject older than 75 years of age.
  • Subject weight is 60 kg or less.
  • Subject who have received intravenous eptifibatide or tirofiban within 48 hours prior to PCI or abciximab within 14 days before or during PCI.
  • Subject taking warfarin or with clinical indication to resume warfarin post PCI for any indication.
  • Subject currently requiring daily treatment with NSAID or COX2 inhibitors.
  • Subject with a known platelet disorder.
  • Subject with known active pathological bleeding or heightened risk of bleeding including but not limited to: gastrointestinal bleeding within 6 months, recent surgery or trauma.
  • Subject with a history of a stroke or TIA
  • Subject with pre-PCI hematocrit or platelet count outside the ranges validated for Verify Now P2Y12 test (33-52% and 119.000-502.000/μL, respectively).
  • Subject with a history of hepatic impairment
  • Subject with known NYHA Class III or greater for heart failure.
  • Inability of subject to provide informed consent.
  • Subject with known hypersensitivity or contraindication to clopidogrel, prasugrel or ASA, which would result in inability of patient to adhere to trial protocol.
  • Presence of valvular heart disease left main coronary artery stenosis or urgent need for CABG.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Maintenance Dose Arm
Open label clopidogrel 75 mg daily or prasugrel 10 mg daily
Drug: Maintenance Dose Arm
Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to a loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.
Other Names:
  • clopidogrel
  • prasugrel
  • thienoyridine
  • Verify now P2Y12
Active Comparator: Loading Dose Arm
Clopidogrel 600 mg or Prasugrel 60 mg at time of PCI.
Drug: Loading Dose Arm
Subjects who are thienopyridine naive will be randomized 1:1 to either clopidogrel 600 mg or prasugrel 60 mg loading dose at the time of PCI. A Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.
Other Names:
  • clopidogrel
  • prasugrel
  • Verify now P2Y12 platelet assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel
Time Frame: 4 hours post medicaton administration
Platelet reactivity will be measured using the Accumetrics Verify Now P2Y12 platelet assay
4 hours post medicaton administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of all bleeding events for subjects enrolled into the trial
Time Frame: 24 hours post PCI or at time of discharge and 30 days post PCI
All bleeding events will be observed, reported and adjudicated by the DSMB
24 hours post PCI or at time of discharge and 30 days post PCI
Occurrence of all MACE events for subjects enrolled into the trial
Time Frame: 24 hours post PCI or at time of discharge and 30 days post PCI
All bleeding events will be observed, reported and adjudicated by the DSMB
24 hours post PCI or at time of discharge and 30 days post PCI

Collaborators and Investigators

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

Sponsor

St. Francis Hospital, New York

Investigators

  • Principal Investigator: Richard A Shlofmitz, MD, Saint Francis Memorial Hospital

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 (Anticipated)

April 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

April 15, 2010

Last Update Submitted That Met QC Criteria

April 14, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-006

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

Clinical Trials on Maintenance Dose Arm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe