Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

NCT ID: NCT01152229

Last Updated: 2011-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Platelet Aggregation Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

nuisance bleeding

No interventions assigned to this group

alarming bleeding

No interventions assigned to this group

maintenance therapy

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cardiovascular Research Institute/ Medstar Health Research Institute

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Gaglia, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington Hospital Center

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PLACID

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.