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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Paxil-CR

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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University of Oklahoma Dept of Pharmacy

Principal Investigators

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Stephen F. Hamilton, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Oklahoma College of Pharmacy

Locations

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The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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1000774

Identifier Type: -

Identifier Source: org_study_id