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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paxil-CR
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • The University of Oklahoma Health Sciences Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2005
Last Updated
September 19, 2008
Sponsor
University of Oklahoma
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00229528
Brief Title
Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
Official Title
Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oklahoma
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paxil-CR
Primary Outcome Measure Information:
Title
To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.
Secondary Outcome Measure Information:
Title
To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen F. Hamilton, Pharm.D.
Organizational Affiliation
The University of Oklahoma College of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States

12. IPD Sharing Statement

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

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