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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin 81mg, Then Aspirin 325mg | Experimental | 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. |
|
| Aspirin 325mg, Then Aspirin 81mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81mg | Drug | 81mg oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum 15R-LXA4 | Week 3, Week 6 | |
| Change in Serum 15R-LXA4 | Week 9, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
1. Age between 40 and 70 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Heffron, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2022 | Dec 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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This is a two-phase crossover design with run-in and wash out periods prior to each phase.
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| Aspirin 325mg | Drug | 325mg oral capsule |
|
| 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 |
| 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |