Overview

This trial is active, not recruiting.

Condition platelet aggregation
Treatment aspirin
Sponsor Vanderbilt University
Start date July 2009
End date February 2011
Trial size 20 participants
Trial identifier NCT00942617, IRB# 080895, NIH/NHLBI #81009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
40 mg non-enteric coated ASA once daily for 21 + or - 2 days
aspirin
40 mg non-enteric coated ASA once daily for 21 + or - 2 days

Primary Outcomes

Measure
The primary measurement will be platelet 5-HT release induced by ADP after 1 and 2 weeks administration of daily ASA.
time frame: 3 weeks

Secondary Outcomes

Measure
Measurements will include platelet COX-1 activity, flow cytometric measurement of markers of platelet activation, platelet aggregation and ATP release, and serum thromboxane B2 (TxB2) levels, at each timepoint.
time frame: 3 weeks

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Official title Measurement of Platelet Dense Granule Release in Healthy Volunteers
Principal investigator John A Oates, M.D.
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 volunteers taking aspirin. One phase of platelet response to activating agonists involves release of dense granules, which are known to contain 5HT (serotonin) and ATP. There are various methods of measuring the degranulation of platelets: ATP release can be measured using a lumiaggregometer, and release of 14C radiolabeled 5-HT from platelets. Using the aggregometer and a 14C labeled 5-HT assay can be used to measure 5-HT release from platelets. Our experience suggests that ADP-induced ATP release is insensitive to detect very low levels of platelet dense granule release, which occurs in aspirin-treated subjects. The pilot study will permit optimizing the method for reliably detecting low levels of 5HT release in patients who achieve submaximal inhibition of the cyclooxygenase during aspirin treatment.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Vanderbilt University.