Body Weight, Aspirin Dose and Pro-resolving Mediators

NCT04697719 | Completed Phase 4 FDA Drug

• 1 other identifier: 20-01884
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Weight

Keywords

Aspirin

Outcome Measures

Primary Outcomes (2)

• Change in Serum 15R-LXA4

  Week 3, Week 6

• Change in Serum 15R-LXA4

  Week 9, Week 12

Secondary Outcomes (20)

• Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)

  Week 3, Week 6

• Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)

  Week 9, Week 12

• Change in lipid mediator profile of leukotrienes

  Week 3, Week 6

• Change in lipid mediator profile of leukotrienes

  Week 9, Week 12

• Change in lipid mediator profile of prostaglandins

  Week 3, Week 6

Study Arms (2)

Aspirin 81mg, Then Aspirin 325mg

EXPERIMENTAL

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.

Drug: Aspirin 81mg; Drug: Aspirin 325mg

Aspirin 325mg, Then Aspirin 81mg

EXPERIMENTAL

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.

Drug: Aspirin 81mg; Drug: Aspirin 325mg

Interventions

Aspirin 325mg DRUG

325mg oral capsule

Aspirin 325mg, Then Aspirin 81mg; Aspirin 81mg, Then Aspirin 325mg

Aspirin 81mg DRUG

81mg oral capsule

Aspirin 325mg, Then Aspirin 81mg; Aspirin 81mg, Then Aspirin 325mg

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age between 40 and 70 years

You may not qualify if:

• Anti-platelet medication use in the past 7 days
• Aspirin intolerance or allergy
• Known bleeding or clotting disorder
• Chronic inflammatory or connective tissue disease
• Immunological deficiency
• Diabetes mellitus
• Prior gastric or bariatric surgery
• Active smoking
• Platelet count \<100,000
• Use of omega-3 fatty acid supplementation
• Use of drugs or supplements known to inhibit COX-1/COX-2/lipoxygenases
• Corticosteroid use
• Recent initiation or change in dose of statin therapy
• Pregnancy

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Body Weight

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sean Heffron, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-phase crossover design with run-in and wash out periods prior to each phase.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: November 4, 2021
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to sean.heffron@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)