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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: GlaxoSmithKline
• Treatments: Paroxetine

Criteria

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