Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

NCT01152229 | Completed

• 1 other identifier: PLACID
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Aggregation; Bleeding

Outcome Measures

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.

  post percutaneous coronary intervention (PCI) while still on clopidogrel

Secondary Outcomes (1)

• Platelet reactivity

  post PCI while still on clopidogrel

Study Arms (3)

nuisance bleeding

alarming bleeding

maintenance therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

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

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Gaglia, MD

  Cardiovascular Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 29, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 3, 2011

Record last verified: 2011-08

Locations

US (1)