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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00229528

Enrollment

Registered

2005-09-29

Start date

2004-03-31

Completion date

2006-05-31

Last updated

2008-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DRUGPaxil-CR

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026