Trials / Unknown
UnknownNCT01103843
Plavix, Prasugrel and Drug Eluting Stents Pilot Trial
PPD Trial Pilot Study: Plavix, Prasugrel and Drug Eluting Stents
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- St. Francis Hospital, New York · Academic / Other
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
* 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2011-04-01
- Completion
- 2011-05-01
- First posted
- 2010-04-15
- Last updated
- 2010-04-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01103843. Inclusion in this directory is not an endorsement.