Phase 4
N=44
Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04765644 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Log Reactive Hyperaemic Index — 0.003; 0.095 LnRHI (Log Reactive hyperaemic index)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Celecoxib (Drug); Placebo (Other); L-arginine + placebo (Other); L-arginine + celecoxib (Other)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Imperial College London
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log Reactive Hyperaemic Index |
0.003; 0.095 | — |
| PRIMARY Augmentation Index |
3.7; -2.54 | — |
| SECONDARY Blood Pressure |
-1.45; 2.03 | — |
| SECONDARY Increase/Decrease of Cardiovascular Biomarkers From Baseline |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- No abnormal findings on medical history, screening physical examination, hematology, biochemistry, urinalysis (including specific gravity), and vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) within 2 weeks of commencement of the study.
- Normal fasting lipid profile
- Non-smoking
- Clear venous access in upper limbs
- BMI: 18-30
- No history or signs of drug abuse
- No other medication 4 weeks before or during the study
- Informed written consent
Exclusion Criteria
- Any history of allergy to NSAIDS or arginine
- Significant medical conditions
- Pulse rate 160 mmHg
- Sitting diastolic pressure 100 mmHg
- Baseline endothelial dysfunction (as defined by EndoPAT; LnRHI <0.51)
- Participation in other clinical study 8 weeks before or during the study
- Donation of blood 8 weeks before or during the study
- Those on medication that cannot be discontinued
Data sourced from ClinicalTrials.gov (NCT04765644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.