Measurement of Platelet Dense Granule Release in Healthy Volunteers

• Status: Withdrawn
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

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 treatment necessitate a more precise method of measuring the "release phase" of platelet activation, including the release of dense granules from platelets.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Males over age 18

• Non-smokers

• No chronic medical illness

• No chronic medications

Exclusion Criteria:

• 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.