- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00942617
Measurement of Platelet Dense Granule Release in Healthy Volunteers
Study Overview
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 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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 40 mg non-enteric coated aspirin
40 mg non-enteric coated ASA once daily for 21 + or - 2 days
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40 mg non-enteric coated ASA once daily for 21 + or - 2 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John A Oates, M.D., Vanderbilt University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- IRB# 080895
- NIH/NHLBI #81009
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