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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01152229
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : August 3, 2011
Information provided by:
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.

Condition or disease
Platelet Aggregation Bleeding

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine
Study Start Date : April 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

nuisance bleeding
alarming bleeding
maintenance therapy

Primary Outcome Measures :
  1. platelet reactivity [ Time Frame: 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 :
  1. Platelet reactivity [ Time Frame: 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01152229

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

Responsible Party: Michael Gaglia, MD, Cardiovascular Research Institute/ Medstar Health Research Institute Identifier: NCT01152229     History of Changes
Other Study ID Numbers: PLACID
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Pathologic Processes