Recruiting

Plavix & PrasugrelPlavix, Prasugrel and Drug Eluting Stents Pilot Trial

Sponsor:

St. Francis Hospital, New York

Code:

NCT01103843

Conditions

Coronary Artery Disease

Platelet Aggregation Inhibitors

PCI- Percutaneous Coronary Intervention

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Loading Dose Arm

Maintenance Dose Arm

Study Details

Brief 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

Coronary Artery Disease

Platelet Aggregation Inhibitors

PCI- Percutaneous Coronary Intervention

Study ID

NCT01103843

Start date

Apr, 2010

Status verified date

Apr, 2010

Completion date

May, 2011

Anticipated

Primary completion date

Apr, 2011

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Maintenance Dose Arm

Open label clopidogrel 75 mg daily or prasugrel 10 mg daily

active comparator: Loading Dose Arm

Clopidogrel 600 mg or Prasugrel 60 mg at time of PCI.

Interventions

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.

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.

Primary outcome measure

Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel [ Time Frame: 4 hours post medicaton administration ]

Central Contacts and Locations

Central contacts

Elizabeth S. Haag, RN, MPA CCRC

516 562-6790 elizabeth.haag@chsli.org

Lyn Santiago, RN,CCRC

516 562-6790 lyn.santiago@chlsi.org

Locations

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

Elizabeth S Haag, RN, MPA,CCRP

516-562-6790 elizabeth.haag@chsli.org

Lyn Santiago, RN,CCRC

516 562-6790 lyn.santiago@chsli.org

Principal Investigator:

Richard A Shlofmitz, MD

More Information

Sponsor

St. Francis Hospital, New York

Last update posted

Apr 15, 2010

Last verified

Apr, 2010

Keywords

Coronary artery disease
clopidogrel
prasugrel
Verify Now
PRU measurements
Drug eluting stents (EDS)
P2Y12
Platelet reactivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Francis Hospital, New York on 2010-04-15.