Status:
WITHDRAWN
Measurement of Platelet Dense Granule Release in Healthy Volunteers
Lead Sponsor:
Vanderbilt University
Conditions:
Platelet Aggregation
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Aspirin has been shown to reduce cardiovascular events in at risk individuals. Elucidation of mechanisms of aspirin resistance and a possible loss of effect of aspirin over time with chronic aspirin t...
Detailed Description
This is a proposal for a pilot study to evaluate the feasibility of measuring 5-hydroxytryptamine (5-HT) release from platelets as an indicator of dense granule release during platelet activation in v...
Eligibility Criteria
Inclusion
- Males over age 18
- Non-smokers
- No chronic medical illness
- No chronic medications
Exclusion
- ASA/NSAID use previous 14 days.
- History of chronic NSAID use.
- Currently taking NSAIDs, opioid analgesics, corticosteroids, or anticoagulants.
- History of coronary artery disease, myocardial infarction, coronary artery bypass grafting, percutaneous angioplasty, diabetes mellitus or stroke.
- History of hypertension
- BMI \>35
- Smokers
- History of gastric, duodenal, or esophageal ulcers or serious gastrointestinal bleed.
- History of frequent headaches, pain syndrome, or other condition requiring frequent use of analgesics.
- History of adverse reaction to ASA.
- Initial platelet count \<100K/µl or \>500K/µl.
- Initial hematocrit \<35% or \>50%.
- Weight less than 110 pounds.
- Female subjects will be excluded to avoid possible confounding uterine smooth muscle production of prostaglandins which various throughout the menstrual cycle.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00942617
Start Date
July 1 2009
End Date
June 1 2012
Last Update
December 7 2015
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232