NCT04765644

Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment

Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment (ASCENT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A single centre, placebo controlled, blinded (participant, investigator, outcome assessor) trial to evaluate the effects of COX-2 inhibition with celecoxib on endothelial function in healthy male volunteers.

Detailed description

Primary Objective: To perform a systemic analysis of how COX-2 inhibition by celecoxib affects vascular function and 'omic biomarkers including those associated with the COX-2/prostacyclin/ADMA axis in healthy male volunteers Secondary Objective: To investigate how this is altered by L-arginine supplementation Methods: A single centre, double blind, placebo controlled trial will be carried out in healthy male volunteers between 18 and 40 years of age. In phase 1, participants will be blinded and randomised to receive either Celecoxib 200mgBD for 7 days or placebo. The primary endpoint is endothelial function measured by EndoPAT. In Phase 2, the same participants will receive either Celecoxib 200mgBD for 7 days + 10g L-arginine supplementation or placebo + 10g L-arginine supplementation to see if L-arginine can reverse any endothelial dysfunction caused by Celecoxib. Secondary outcomes will include measurement of 'omic biomarkers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Celecoxib	Two 200 mg capsules per day (400 mg/day) for 7 days
OTHER	Placebo	2 capsules/day for 7 days
OTHER	L-arginine + placebo	L-arginine = Five capsules of 2 mg per day (10 mg/day) for 7 days Placebo = 2 capsules/day for 7 days
OTHER	L-arginine + celecoxib	L-arginine = Five capsules of 2 mg per day (10 mg/day) Celecoxib = Two 200 mg capsules per day (400 mg/day) for 7 days

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-01-24
• Completion: 2022-01-24
• First posted: 2021-02-21
• Last updated: 2026-04-17
• Results posted: 2024-10-28

Locations

1 site across 1 country: United Kingdom