Official Title: “Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease”

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.

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study

Study Primary Completion Date: May 2006

Intervention(s) in this Clinical Trial

• Drug: Paxil-CR

Primary Measures

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

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Oklahoma

Overall Clinical Trial Officials and Contacts

Stephen F. Hamilton, Pharm.D. Principal Investigator The University of Oklahoma College of Pharmacy  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00229528

Study ID Number: 1000774

ClinicalTrials.gov Identifier: NCT00229528

Health Authority: United States: Food and Drug Administration