Body Weight, Aspirin Dose and Pro-resolving Mediators

DISCOVER: A Single-site Double-blind Placebo-controlled Randomized Mechanistic Crossover Trial to Assess the Influence of boDy weIght on aSpirin-triggered speCialized prO-resolVing mEdiatoRs

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.

Study Overview

• Status: Completed
• Conditions: Body Weight
• Intervention / Treatment: Drug: Aspirin 81mg; Drug: Aspirin 325mg

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Aspirin 81mg; 81mg oral capsule; Drug: Aspirin 325mg; 325mg oral capsule
Experimental: 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.	Drug: Aspirin 81mg; 81mg oral capsule; Drug: Aspirin 325mg; 325mg oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Serum 15R-LXA4	Week 3, Week 6
Change in Serum 15R-LXA4	Week 9, Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in platelet-monocyte aggregates	Week 3, Week 6
Change in platelet-monocyte aggregates	Week 9, Week 12
Change in platelet-neutrophil aggregates	Week 3, Week 6
Change in platelet-neutrophil aggregates	Week 9, Week 12
Change in platelet surface expression of CD62P	Week 3, Week 6
Change in platelet surface expression of CD62P	Week 9, Week 12
Change in leukocyte expression of ALX/FPR2	Week 3, Week 6
Change in leukocyte expression of ALX/FPR2	Week 9, Week 12
Change in leukocyte expression of GPR32	Week 3, Week 6
Change in leukocyte expression of GPR32	Week 9, Week 12
Change in leukocyte expression of ERV1/ChemR23	Week 3, Week 6
Change in leukocyte expression of ERV1/ChemR23	Week 9, Week 12
Change in leukocyte expression of BLT1	Week 3, Week 6
Change in leukocyte expression of BLT1	Week 9, Week 12
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
Change in lipid mediator profile of prostaglandins	Week 9, Week 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Sean Heffron, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): January 29, 2025
• Study Completion (Actual): January 29, 2025

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Aspirin
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Weight; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Salicylates; Hydroxybenzoates; Aspirin
• Other Study ID Numbers: 20-01884

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes