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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
- Study Primary Completion Date: May 2006
Intervention(s) in this Clinical Trial
- Drug: Paxil-CR
Outcome Measures for this Clinical Trial
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.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: University of Oklahoma Other
Overall Clinical Trial Officials and Contacts
Stephen F. Hamilton, Pharm.D. Principal Investigator The University of Oklahoma College of Pharmacy
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00229528
