PLACID: Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01152229
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 20

Study Details

Study Description

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	Intervention/Treatment	Phase
Platelet Aggregation; Bleeding

Study Design

• Study Type: Observational
• Anticipated 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: Apr 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
nuisance bleeding
alarming bleeding
maintenance therapy

Outcome Measures

Primary Outcome Measures

1. platelet reactivity [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 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Hospital Center	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• Medstar Health Research Institute

Investigators

• Principal Investigator: Michael Gaglia, MD, Cardiovascular Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01152229
• Other Study ID Numbers: PLACID
• First Posted: Jun 29, 2010
• Last Update Posted: Aug 3, 2011
• Last Verified: Aug 1, 2011

• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Aug 3, 2011