NCT04765644: ASCENT

Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment

Completed Phase 4 Results posted Last updated 17 April 2026

What this trial tests

Phase 4 trial testing Celecoxib in Healthy in 44 participants. Completed in 24 January 2022.

Timeline

10 June 2021

Primary endpoint
24 January 2022

24 January 2022

Quick facts

Lead sponsor	Imperial College London
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	44
Start date	10 June 2021
Primary completion	24 January 2022
Estimated completion	24 January 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Celecoxib (celecoxib) — full drug profile →
• Placebo
• L-arginine + placebo
• L-arginine + celecoxib

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Imperial College London

Who can join

Adults 18 to 40, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Log Reactive Hyperaemic Index Primary · Baseline and 7 days

Measured using the EndoPAT 2000 device (which is an FDA approved medical device). Data are issued by the equipment as: LnRHI (Log Reactive hyperaemic index), a reduction from the individual participant baseline value indicates endothelial dysfunction

Group	Value	95% CI
Celecoxib	0.003	± 0.35
Placebo	0.095	± 0.33

Augmentation Index Primary · Baseline and 7 days

Measured using the EndoPAT 2000 device (which is an FDA approved medical device) at baseline and at 7 days. Data are issued by the equipment. Augmentation index (which is a surrogate for vascular stiffness). An increase indicates an increase in vascular stiffness.

Group	Value	95% CI
Celecoxib	3.7	± 9.05
Placebo	-2.54	± 10.24

Blood Pressure Secondary · Baseline and 7 Days

Participants will record their blood pressure daily using a home monitoring device at rest on day 1 (baseline) and day 7. Reported as change in systolic blood pressure (delta) from baseline.

Group	Value	95% CI
Celecoxib	-1.45	± 11.8
Placebo	2.03	± 7.97

Increase/Decrease of Cardiovascular Biomarkers From Baseline Secondary · Baseline and 7 days

Measured using mass spectrometry on serum samples collected at baseline and at 7 days.

Group	Value	95% CI
Celecoxib	0
Placebo	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.