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

University of Oklahoma (OU)

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Paxil-CR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00229528

1000774

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)