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

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Paxil-CR

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00229528
1000774

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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