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CompletedNCT01152229PLACIDUpdated Aug 3, 2011

Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

An observational study in Platelet Aggregation and Bleeding, sponsored by Medstar Health Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-03.

Sponsored by Medstar Health Research Institute · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Platelet Aggregation
  • Bleeding

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03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 300 is above the median of 150 across 893 observational studies indexed under Hemorrhage.

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Lead sponsor

Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
300 participants (estimated)

Groups and cohorts

  • nuisance bleeding
  • alarming bleeding
  • maintenance therapy
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: post percutaneous coronary intervention (PCI) while still on clopidogrel

Secondary outcomes

  1. 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).

    Time frame: post PCI while still on clopidogrel

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Study locations

1 site
  • Washington Hospital Center
    Washington, District of Columbia 20010, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01152229
Lead sponsor
Medstar Health Research Institute
First posted
Jun 29, 2010
Start date
Apr 2010
Primary completion
Jun 2011
Completion
Jul 2011
Last update
Aug 3, 2011

Study contacts

Michael Gaglia, MD
principal investigator · Cardiovascular Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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