Body Weight, Aspirin Dose and Pro-resolving Mediators

NCT ID: NCT04697719

Last Updated: 2025-05-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-04

Study Completion Date

2025-01-29

Brief Summary

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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.

Detailed Description

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Conditions

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Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a two-phase crossover design with run-in and wash out periods prior to each phase.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

Aspirin 81mg

Intervention Type DRUG

81mg oral capsule

Aspirin 325mg

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Aspirin 81mg

Intervention Type DRUG

81mg oral capsule

Aspirin 325mg

Intervention Type DRUG

325mg oral capsule

Interventions

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Aspirin 81mg

81mg oral capsule

Intervention Type DRUG

Aspirin 325mg

325mg oral capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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20-01884

Identifier Type: -

Identifier Source: org_study_id

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