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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 coronary-artery-disease
Started Mar 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 27, 2005
CompletedFirst Posted
Study publicly available on registry
September 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedSeptember 22, 2008
September 1, 2008
2.2 years
September 27, 2005
September 19, 2008
Conditions
Outcome Measures
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.
Interventions
Eligibility Criteria
You may qualify if:
- normal volunteers (without heart disease)
- patients with heart disease
- between ages 18 \& 65
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oklahomalead
- GlaxoSmithKlinecollaborator
Study Sites (1)
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen F. Hamilton, Pharm.D.
The University of Oklahoma College of Pharmacy
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 27, 2005
First Posted
September 29, 2005
Study Start
March 1, 2004
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
September 22, 2008
Record last verified: 2008-09