Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

Bleeding Clinical Trial

— PLACID  

Official title:

Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152229
• Other study ID #: PLACID
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: August 1, 2011
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Platelet Aggregation

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet reactivity	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.	post percutaneous coronary intervention (PCI) while still on clopidogrel	No
Secondary	Platelet reactivity	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).	post PCI while still on clopidogrel	No