Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2021-11-04
2025-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Aspirin 81mg, Then Aspirin 325mg
After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.
Aspirin 81mg
81mg oral capsule
Aspirin 325mg
325mg oral capsule
Aspirin 325mg, Then Aspirin 81mg
After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.
Aspirin 81mg
81mg oral capsule
Aspirin 325mg
325mg oral capsule
Interventions
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Aspirin 81mg
81mg oral capsule
Aspirin 325mg
325mg oral capsule
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Aspirin intolerance or allergy
3. Known bleeding or clotting disorder
4. Chronic inflammatory or connective tissue disease
5. Immunological deficiency
6. Diabetes mellitus
7. Prior gastric or bariatric surgery
8. Active smoking
9. Platelet count \<100,000
10. Use of omega-3 fatty acid supplementation
11. Use of drugs or supplements known to inhibit COX-1/COX-2/lipoxygenases
12. Corticosteroid use
13. Recent initiation or change in dose of statin therapy
14. Pregnancy
40 Years
70 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Sean Heffron, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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20-01884
Identifier Type: -
Identifier Source: org_study_id
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