Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

Completed

• Conditions: Platelet Aggregation; Bleeding

• Registration Number: NCT01152229
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

The objective is to describe and quantify levels of platelet reactivity in three different cohorts of patients taking thienopyridine: patients who report nuisance bleeding, patients who report alarming bleeding, and patients who report no nuisance or alarming bleeding. The investigators hypothesize that patients with nuisance or alarming bleeding events on maintenance thienopyridine therapy will have lower levels of platelet reactivity than patients without nuisance or alarming bleeding on thienopyridine therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-29
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients 18 years or older from both genders
• Underwent PCI within the last year
• Taking maintenance dose of clopidogrel 75 mg once a day or prasugrel 10 mg once a day for at least five days

Exclusion Criteria

• Known allergies to aspirin, clopidogrel, or prasugrel.
• Use of a glycoprotein (GP)IIb/IIIa inhibitor within 8 hours of the blood draw.
• Patient known to be pregnant or lactating
• Patient with known history of anemia, thrombocytopenia, bleeding disorder, or currently active bleeding
• On warfarin therapy at the time of blood draw
• Known blood transfusion within the preceding 10 days of the blood draw
• Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS, not to include aspirin) within the previous 5 days
• Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
platelet reactivity	post percutaneous coronary intervention (PCI) while still on clopidogrel	Level of platelet reactivity as assessed with the Chrono-Log Lumi-Aggregometer, which measures levels of light transmittance after stimulation with ADP to estimate levels of platelet aggregation.

Secondary Outcome Measures

Name	Time	Method
Platelet reactivity	post PCI while still on clopidogrel	* Platelet reactivity, as measured with the VerifyNow P2Y12 assay, expressed as platelet reactivity units (PRUs); * Platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay, which measures percentage platelet reactivity inhibition by flow cytometry of the VASP-P protein.; * Aspirin resistance, as assessed with the VerifyNow aspirin resistance assay, which measures aspirin resistance (ARUs).

Trial Locations

Locations (1)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States