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Clinical Trials in China / NCT07328100
Starting soon Not applicable

Efficacy and Safety of Coenzyme I for Injection on Vascular Aging.

NCT07328100 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai 10th People's Hospital
Phase
Not applicable
Started
2026-01-16
Last updated
2026-01-08

Condition(s) studied

Vascular AgingNAD

Investigational drug(s) / intervention(s)

Coenzyme I for Injection →NaCl (placebo)

Coenzyme I for Injection: Subjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection.

NaCl (placebo): Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%).

Study summary

Emerging evidence identifies vascular aging independently predicting cardiovascular events, yet effective clinical interventions remain lacking. Nicotinamide adenine dinucleotide (NAD+) is an essential cofactor whose levels decline with age, and preclinical studies suggest that boosting NAD+ can improve vascular function and structure. Preliminary clinical studies in healthy older adults indicate that supplementation with NAD+ precursors, such as nicotinamide riboside(NR) or nicotinamide mononucleotide (NMN), can reduce arterial stiffness as measured by pulse wave velocity (PWV). However, whether NAD+ supplementation can improve vascular endothelial function and exert anti-stiffening effects in patients who have already developed measurable arterial stiffness remains unknown. Based on this evidence, the investigator hypothesize that the Coenzyme I for Injection will reverse vascular aging in older adults with established arterial stiffening.

Eligibility

Sex
ALL
Min age
40 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Ages 40-70 years; 2. cf-PWV was abnormally elevated and above the upper limit of its age-and blood-pressure matched reference range; 3. Systolic Blood Pressure \< 160 mmHg and ≥ 140 mmHg or Diastolic BP \< 100 mmHg ≥ 90mmHg; 4. Signed informed consent. Exclusion Criteria: 1. Consumption of foods or medications containing high levels of NAD+, NR, NAM, NMN, or niacin-related components (including Vitamin B3 and natural health products) within 3 months prior to screening； 2. History of major cardiovascular or cerebrovascular events, including myocardial infarction, angina, stroke, or hospitalization for arterial revascularization； 3. Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg； 4. Diagnosis of malignant tumor； 5. Known allergy or history of severe adverse reactions to Coenzyme I injection or any of its components； 6. History of severe allergies or infusion reactions； 7. Women who are pregnant, breastfeeding, or planning pregnancy； 8. Severe hepatic or renal dysfunction: ALT or AST \> 5 times the upper limit of normal; glomerular filtration rate ≤ 30 mL/min/1.73 m²； 9. Concurrent participation in another clinical trial without completion of the follow-up period； 10. Other conditions deemed by the investigator as unsuitable for inclusion, such as psychiatric or psychological disorders.

Primary outcome measure(s)

  • The change in flow-mediated vasodilation(FMD) — Day 8/28
    Changes in FMD from baseline to day 8/28.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Tenth People's Hospital Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07328100 on ClinicalTrials.gov ↗ ← All trials in China