Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease

Phase 4

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00229528
• Lead Sponsor: University of Oklahoma

Brief Summary

COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the current study is designed to determine whether paroxetine will decrease COAT-platelet production in normal volunteers and patients with cardiovascular disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-29
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-19
• Last Update Posted: 2008-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• normal volunteers (without heart disease)
• patients with heart disease
• between ages 18 & 65

Exclusion Criteria

• children less than 18 years
• adults greater than 65 years
• those who can not keep appointments
• patients within 2 weeks of a coronary catheterization
• patients within 6 months of unstable angina or myocardial infarction
• individuals with allergies to paroxetine or similar medications
• individuals having adverse events to paroxetine or similar medications
• individuals with diagnosis of mania
• individuals with a diagnosis of hypomania
• individuals with a diagnosis of bipolar disorders
• individuals with a diagnosis of depression
• individuals with a diagnosis of panic disorders
• individuals with a diagnosis of seizure disorders
• individuals with a history of suicide attempts
• individuals with a diagnosis of hyponatremia
• individuals with active bleeding disorders
• individuals with a diagnosis of narrow angle glaucoma
• individuals with an estimated creatinine clearance of less that 30 ml/min
• individuals taking potentially interacting medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.

Secondary Outcome Measures

Name	Time	Method
To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.

Trial Locations

Locations (1)

The University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States