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CompletedNCT04697719Updated Mar 9, 2026

Body Weight, Aspirin Dose and Pro-resolving Mediators

A Phase 4 interventional study of Aspirin 81mg and Aspirin 325mg in Body Weight, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by NYU Langone Health · Phase 4, Interventional, and Other

From the registry’s dates

  • Primary completion was Jan 2025, 1 year 8 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Jan 2026.
Phase
Phase 4
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Body Weight

Browse trials for

Keywords

  • Aspirin
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 103 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

1. Age between 40 and 70 years

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
103 participants (actual)

Study arms

  • 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 · Drug: Aspirin 325mg

  • 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 · Drug: Aspirin 325mg

Interventions

  • DrugAspirin 81mg

    81mg oral capsule

  • DrugAspirin 325mg

    325mg oral capsule

06

What researchers measure

Primary outcomes

  1. Change in Serum 15R-LXA4

    Time frame: Week 3, Week 6

  2. Change in Serum 15R-LXA4

    Time frame: Week 9, Week 12

Secondary outcomes

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

    Time frame: Week 3, Week 6

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

    Time frame: Week 9, Week 12

  3. Change in lipid mediator profile of leukotrienes

    Time frame: Week 3, Week 6

  4. Change in lipid mediator profile of leukotrienes

    Time frame: Week 9, Week 12

  5. Change in lipid mediator profile of prostaglandins

    Time frame: Week 3, Week 6

  6. Change in lipid mediator profile of prostaglandins

    Time frame: Week 9, Week 12

  7. Change in platelet-monocyte aggregates

    Time frame: Week 3, Week 6

  8. Change in platelet-monocyte aggregates

    Time frame: Week 9, Week 12

  9. Change in platelet-neutrophil aggregates

    Time frame: Week 3, Week 6

  10. Change in platelet-neutrophil aggregates

    Time frame: Week 9, Week 12

  11. Change in platelet surface expression of CD62P

    Time frame: Week 3, Week 6

  12. Change in platelet surface expression of CD62P

    Time frame: Week 9, Week 12

  13. Change in leukocyte expression of ALX/FPR2

    Time frame: Week 3, Week 6

  14. Change in leukocyte expression of ALX/FPR2

    Time frame: Week 9, Week 12

  15. Change in leukocyte expression of GPR32

    Time frame: Week 3, Week 6

  16. Change in leukocyte expression of GPR32

    Time frame: Week 9, Week 12

  17. Change in leukocyte expression of ERV1/ChemR23

    Time frame: Week 3, Week 6

  18. Change in leukocyte expression of ERV1/ChemR23

    Time frame: Week 9, Week 12

  19. Change in leukocyte expression of BLT1

    Time frame: Week 3, Week 6

  20. Change in leukocyte expression of BLT1

    Time frame: Week 9, Week 12

07

Study locations

1 site
  • NYU Langone Health
    New York, New York 10016, United States
08

References and documents

Study documents

  • Informed consent form · Aug 3, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Supporting information: Study protocol, Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04697719
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jan 6, 2021
Start date
Nov 4, 2021
Primary completion
Jan 29, 2025
Completion
Jan 29, 2025
Last update
Mar 9, 2026

Study contacts

Sean Heffron, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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