Body Weight, Aspirin Dose and Pro-resolving Mediators

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Body Weight

Treatments: Drug: Aspirin 81mg; Drug: Aspirin 325mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04697719

20-01884

Details and patient eligibility

About

This study employs a placebo-controlled randomized cross-over design to investigate the impact of body weight and aspirin dose on levels of specialized pro-resolving lipid mediators in blood and neutrophils.

Enrollment: 103 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age between 40 and 70 years

Exclusion criteria

1. Anti-platelet medication use in the past 7 days
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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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103 participants in 2 patient groups

Aspirin 81mg, Then Aspirin 325mg

Experimental group

Description:

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.

Treatment:

Drug: Aspirin 325mg

Drug: Aspirin 81mg

Aspirin 325mg, Then Aspirin 81mg

Experimental group

Description:

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.

Treatment:

Drug: Aspirin 325mg

Drug: Aspirin 81mg