Trial Outcomes & Findings for Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment (NCT NCT04765644)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

Baseline and 7 days

Results posted on

2024-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Celecoxib 22 participants were randomised and allocated to the celecoxib arm (200mg capsule taken orally twice a day for 7 days. Of these 2 participants withdrew from the study before the second study visit. In the final analysis there were 20 participants in the celecoxib arm.	Placebo 22 participants were randomised and allocated to the placebo arm (identical capsule to celecoxib containing placebo, 1 capsule taken orally twice daily for 7 days). Of these 2 participants were withdrawn from the study due to concomitant viral infection during the study week. In the final analysis there were 20 participants in the Placebo arm.
Overall Study STARTED	22	22
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celecoxib n=20 Participants Celecoxib	Placebo n=20 Participants Placebo	Total n=40 Participants Total of all reporting groups
Age, Continuous	25.5 years STANDARD_DEVIATION 6 • n=5 Participants	27.1 years STANDARD_DEVIATION 6 • n=7 Participants	26.8 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Oriental	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Mixed	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 7 days

Population: Data presented as mean change from baseline (delta)

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

Outcome measures

Outcome measures
Measure	Celecoxib n=20 Participants Celecoxib 200mg capsule taken orally twice a day for 7 days	Placebo n=20 Participants Identical capsule to celecoxib containing placebo, 1 capsule taken orally twice daily for 7 days
Log Reactive Hyperaemic Index	0.003 LnRHI (Log Reactive hyperaemic index) Standard Deviation 0.35	0.095 LnRHI (Log Reactive hyperaemic index) Standard Deviation 0.33

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Celecoxib n=20 Participants Celecoxib 200mg capsule taken orally twice a day for 7 days	Placebo n=20 Participants Identical capsule to celecoxib containing placebo, 1 capsule taken orally twice daily for 7 days
Augmentation Index	3.7 Augmentation Index Standard Deviation 9.05	-2.54 Augmentation Index Standard Deviation 10.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Celecoxib n=20 Participants Celecoxib 200mg capsule taken orally twice a day for 7 days	Placebo n=20 Participants Identical capsule to celecoxib containing placebo, 1 capsule taken orally twice daily for 7 days
Blood Pressure	-1.45 mmHg Standard Deviation 11.8	2.03 mmHg Standard Deviation 7.97

SECONDARY outcome

Timeframe: Baseline and 7 days

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

Outcome measures

Outcome data not reported

Adverse Events

Celecoxib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ricky Vaja

Imperial College London

Phone: 020 7589 5111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place