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Body Weight, Aspirin Dose and Pro-resolving Mediators

Primary Purpose

Body Weight

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aspirin 81mg

Aspirin 325mg

About this trial

This is an interventional other trial for Body Weight focused on measuring Aspirin

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. 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

Sites / Locations

NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Aspirin 81mg, Then Aspirin 325mg

Aspirin 325mg, Then Aspirin 81mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Serum 15R-LXA4

Secondary Outcome Measures

Change in serum and neutrophil supernatant lipid mediators

Change in platelet-monocyte aggregates

Change in platelet-neutrophil aggregates

Change in platelet surface expression of CD62P

Change in leukocyte expression of ALX/FPR2

Change in leukocyte expression of GPR32

Change in leukocyte expression of ERV1/ChemR23

Change in leukocyte expression of BLT1

Full Information

NCT ID

NCT04697719

First Posted

January 4, 2021

Last Updated

January 24, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT04697719

Brief Title

Body Weight, Aspirin Dose and Pro-resolving Mediators

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 4, 2021 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

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

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Body Weight

Keywords

Aspirin

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aspirin 81mg, Then Aspirin 325mg

Arm Type

Experimental

Arm Description

Arm Title

Aspirin 325mg, Then Aspirin 81mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aspirin 81mg

Intervention Description

81mg oral capsule

Intervention Type

Drug

Intervention Name(s)

Aspirin 325mg

Intervention Description

325mg oral capsule

Primary Outcome Measure Information:

Title

Change in Serum 15R-LXA4

Time Frame

Week 3, Week 6

Title

Change in Serum 15R-LXA4

Time Frame

Week 9, Week 12

Secondary Outcome Measure Information:

Title

Change in serum and neutrophil supernatant lipid mediators

Time Frame

Week 3, Week 6

Title

Change in serum and neutrophil supernatant lipid mediators

Time Frame

Week 9, Week 12

Title

Change in platelet-monocyte aggregates

Time Frame

Week 3, Week 6

Title

Change in platelet-monocyte aggregates

Time Frame

Week 9, Week 12

Title

Change in platelet-neutrophil aggregates

Time Frame

Week 3, Week 6

Title

Change in platelet-neutrophil aggregates

Time Frame

Week 9, Week 12

Title

Change in platelet surface expression of CD62P

Time Frame

Week 3, Week 6

Title

Change in platelet surface expression of CD62P

Time Frame

Week 9, Week 12

Title

Change in leukocyte expression of ALX/FPR2

Time Frame

Week 3, Week 6

Title

Change in leukocyte expression of ALX/FPR2

Time Frame

Week 9, Week 12

Title

Change in leukocyte expression of GPR32

Time Frame

Week 3, Week 6

Title

Change in leukocyte expression of GPR32

Time Frame

Week 9, Week 12

Title

Change in leukocyte expression of ERV1/ChemR23

Time Frame

Week 3, Week 6

Title

Change in leukocyte expression of ERV1/ChemR23

Time Frame

Week 9, Week 12

Title

Change in leukocyte expression of BLT1

Time Frame

Week 3, Week 6

Title

Change in leukocyte expression of BLT1

Time Frame

Week 9, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sean Heffron, MD

Phone

212-263-0855

sean.heffron@nyulangone.org

First Name & Middle Initial & Last Name or Official Title & Degree

Natalie McGowan, BS

Phone

646-819-2034

natalie.mcgowan@nyulangone.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean Heffron, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sean Heffron, MD

Sean.Heffron@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Body Weight, Aspirin Dose and Pro-resolving Mediators

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