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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00229528
First received: September 27, 2005
Last updated: September 19, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Paxil-CR
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

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.

Estimated Enrollment: 25
Study Start Date: March 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229528

Locations
United States, Oklahoma
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
Sponsors and Collaborators
University of Oklahoma
GlaxoSmithKline
Investigators
Principal Investigator: Stephen F. Hamilton, Pharm.D. The University of Oklahoma College of Pharmacy
  More Information

No publications provided

Responsible Party: Stephen Hamilton, University of Oklahoma Dept of Pharmacy
ClinicalTrials.gov Identifier: NCT00229528     History of Changes
Other Study ID Numbers: 1000774
Study First Received: September 27, 2005
Last Updated: September 19, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013