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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by St. Francis Hospital, New York.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Francis Hospital, New York
ClinicalTrials.gov Identifier:
NCT01103843
First received: April 14, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose
  • 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).

Condition Intervention
Coronary Artery Disease
Platelet Aggregation Inhibitors
PCI- Percutaneous Coronary Intervention
Drug: Loading Dose Arm
Drug: Maintenance Dose Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PPD Trial Pilot Study: Plavix, Prasugrel and Drug Eluting Stents

Resource links provided by NLM:


Further study details as provided by St. Francis Hospital, New York:

Primary Outcome Measures:
  • Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel [ Time Frame: 4 hours post medicaton administration ] [ Designated as safety issue: Yes ]
    Platelet reactivity will be measured using the Accumetrics Verify Now P2Y12 platelet assay


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    All bleeding events will be observed, reported and adjudicated by the DSMB

  • 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 ] [ Designated as safety issue: Yes ]
    All bleeding events will be observed, reported and adjudicated by the DSMB


Estimated Enrollment: 1000
Study Start Date: April 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • thienoyridine
  • Verify now P2Y12
  • prasugrel
  • clopidogrel
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103843

Contacts
Contact: Elizabeth S. Haag, RN, MPA CCRC 516 562-6790 elizabeth.haag@chsli.org
Contact: Lyn Santiago, RN,CCRC 516 562-6790 lyn.santiago@chlsi.org

Locations
United States, New York
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Elizabeth S Haag, RN, MPA,CCRP    516-562-6790    elizabeth.haag@chsli.org   
Contact: Lyn Santiago, RN,CCRC    516 562-6790    lyn.santiago@chsli.org   
Principal Investigator: Richard A Shlofmitz, MD         
Sponsors and Collaborators
St. Francis Hospital, New York
Investigators
Principal Investigator: Richard A Shlofmitz, MD Saint Francis Memorial Hospital
  More Information

Publications:

Responsible Party: Richard A. Shlofmitz, MD, FACC- Chairman Department of Cardiology, St. Francis Hospital- The Heart Center
ClinicalTrials.gov Identifier: NCT01103843     History of Changes
Other Study ID Numbers: 10-006
Study First Received: April 14, 2010
Last Updated: April 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by St. Francis Hospital, New York:
Coronary artery disease
clopidogrel
prasugrel
Verify Now
PRU measurements
Drug eluting stents (EDS)
P2Y12
Platelet reactivity

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014