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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229528
• Other study ID #: 1000774
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2005
• Last updated: September 19, 2008
• Start date: March 2004
• Est. completion date: May 2006

Study information

• Verified date: September 2008
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Paxil-CR

Locations

Country	Name	City	State
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.
Secondary	To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.