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Body Weight, Aspirin Dose and Pro-resolving Mediators

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ClinicalTrials.gov Identifier: NCT04697719
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : November 4, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Aspirin

Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in serum and neutrophil supernatant lipid mediators [ Time Frame: Week 3, Week 6 ]
  2. Change in serum and neutrophil supernatant lipid mediators [ Time Frame: Week 9, Week 12 ]
  3. Change in platelet-monocyte aggregates [ Time Frame: Week 3, Week 6 ]
  4. Change in platelet-monocyte aggregates [ Time Frame: Week 9, Week 12 ]
  5. Change in platelet-neutrophil aggregates [ Time Frame: Week 3, Week 6 ]
  6. Change in platelet-neutrophil aggregates [ Time Frame: Week 9, Week 12 ]
  7. Change in platelet surface expression of CD62P [ Time Frame: Week 3, Week 6 ]
  8. Change in platelet surface expression of CD62P [ Time Frame: Week 9, Week 12 ]
  9. Change in leukocyte expression of ALX/FPR2 [ Time Frame: Week 3, Week 6 ]
  10. Change in leukocyte expression of ALX/FPR2 [ Time Frame: Week 9, Week 12 ]
  11. Change in leukocyte expression of GPR32 [ Time Frame: Week 3, Week 6 ]
  12. Change in leukocyte expression of GPR32 [ Time Frame: Week 9, Week 12 ]
  13. Change in leukocyte expression of ERV1/ChemR23 [ Time Frame: Week 3, Week 6 ]
  14. Change in leukocyte expression of ERV1/ChemR23 [ Time Frame: Week 9, Week 12 ]
  15. Change in leukocyte expression of BLT1 [ Time Frame: Week 3, Week 6 ]
  16. Change in leukocyte expression of BLT1 [ Time Frame: Week 9, Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697719


Contacts
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Contact: Sean Heffron, MD 212-263-0855 sean.heffron@nyulangone.org
Contact: Natalie McGowan, BS 646-819-2034 natalie.mcgowan@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Sean Heffron, MD       Sean.Heffron@nyulangone.org   
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Sean Heffron, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04697719    
Other Study ID Numbers: 20-01884
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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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
Keywords provided by NYU Langone Health:
Aspirin
Additional relevant MeSH terms:
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Body Weight
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics