Skip to main content
OpenTrials
Completed

NCT Number: NCT00229528

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paxil-CR

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 29, 2005
Registry last updated
Sep 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.