Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01152229

Acronym

PLACID

Enrollment

300

Registered

2010-06-29

Start date

2010-04-30

Completion date

2011-07-31

Last updated

2011-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Platelet Aggregation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results