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Completed

NCT Number: NCT01152229

Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

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.

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Key information

Conditions

Platelet Aggregation Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Acronym: PLACID

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2010
Registry last updated
Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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