Plavix, Prasugrel and Drug Eluting Stents Pilot Trial (PPD)
|ClinicalTrials.gov Identifier: NCT01103843|
Recruitment Status : Unknown
Verified April 2010 by St. Francis Hospital, New York.
Recruitment status was: Recruiting
First Posted : April 15, 2010
Last Update Posted : April 15, 2010
- 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 or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Platelet Aggregation Inhibitors PCI- Percutaneous Coronary Intervention||Drug: Loading Dose Arm Drug: Maintenance Dose Arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||PPD Trial Pilot Study: Plavix, Prasugrel and Drug Eluting Stents|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||May 2011|
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.
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.
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103843
|Contact: Elizabeth S. Haag, RN, MPA CCRC||516 firstname.lastname@example.org|
|Contact: Lyn Santiago, RN,CCRC||516 email@example.com|
|United States, New York|
|St. Francis Hospital||Recruiting|
|Roslyn, New York, United States, 11576|
|Contact: Elizabeth S Haag, RN, MPA,CCRP 516-562-6790 firstname.lastname@example.org|
|Contact: Lyn Santiago, RN,CCRC 516 562-6790 email@example.com|
|Principal Investigator: Richard A Shlofmitz, MD|
|Principal Investigator:||Richard A Shlofmitz, MD||Saint Francis Memorial Hospital|