Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765644
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2021-02-17
Brief Title:
Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment ASCENT
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASCENT
Brief 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-2prostacyclinADMA 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None