NCT03590821

Timed Aspirin Chronobiome Study

Modulating Celecoxib Induced Blood Pressure Changes by Timed Administration of Aspirin and the Human Chronobiome

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To determine whether timed administration of aspirin ameliorates the effects of celecoxib on blood pressure.

Detailed description

Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly used and effective treatment of inflammatory pain. However, all NSAID have the potential to raise blood pressure (BP), cause the development of new hypertension or exacerbate preexisting hypertension. Strategies to mitigating that risk short of withholding the analgesic are missing. In this proposal, the investigators wish to determine whether timed administration of low dose aspirin can be developed as a low cost intervention with well-defined risk profile to mitigate the blood pressure raise associated with the COX-2 selective NSAID celecoxib. Low dose aspirin administered in the evening, but not in the morning, normalizes the mean arterial BP in clinical studies of prehypertension, mild essential hypertension and preeclampsia. The investigators will address this in an interventional study in healthy volunteers who displayed a blood pressure increase during celecoxib treatment in an ongoing study. Since individuals have varying chronotypes and work/social rhythms, parameter measuring day/night patterns, the chronobiome, will be part of this study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Aspirin 81 mg	timed administration of aspirin in the evening
DRUG	Celecoxib 200mg capsule	daily administration of celecoxib

Timeline

• Start date: 2027-12-01
• Primary completion: 2028-01-01
• Completion: 2028-11-01
• First posted: 2018-07-18
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study