Body Weight, Aspirin Dose and Pro-resolving Mediators

Sponsor

NYU Langone Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04697719

Collaborator

(none)

125

Enrollment

Location

Arms

28.8

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Weight	Drug: Aspirin 81mg Drug: Aspirin 325mg	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 4, 2021

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Serum 15R-LXA4 [Week 3, Week 6]
Change in Serum 15R-LXA4 [Week 9, Week 12]

Secondary Outcome Measures

Change in serum and neutrophil supernatant lipid mediators [Week 3, Week 6]
Change in serum and neutrophil supernatant lipid mediators [Week 9, Week 12]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 40 and 70 years

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Sean Heffron, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT04697719

Other Study ID Numbers:

20-01884

First Posted:

Jan 6, 2021

Last Update Posted:

Mar 9, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by NYU Langone Health

Aspirin

Additional relevant MeSH terms:

Body Weight

Aspirin

Study Results

No Results Posted as of Mar 9, 2022