Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine (PLACID)

This study has been completed.
Sponsor:
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01152229
First received: May 28, 2010
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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.


Condition
Platelet Aggregation
Bleeding

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • platelet reactivity [ Time Frame: post percutaneous coronary intervention (PCI) while still on clopidogrel ] [ Designated as safety issue: No ]
    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:
  • Platelet reactivity [ Time Frame: post PCI while still on clopidogrel ] [ Designated as safety issue: No ]
    • 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).


Estimated Enrollment: 300
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
nuisance bleeding
alarming bleeding
maintenance therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have undergone PCI and have reported no bleeding, nuisance bleeding or alarming bleeding.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01152229

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Michael Gaglia, MD Cardiovascular Research Institute
  More Information

No publications provided

Responsible Party: Michael Gaglia, MD, Cardiovascular Research Institute/ Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01152229     History of Changes
Other Study ID Numbers: PLACID
Study First Received: May 28, 2010
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014