Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07328100

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 40-70 years;
  • cf-PWV was abnormally elevated and above the upper limit of its age-and blood-pressure matched reference range;
  • Systolic Blood Pressure < 160 mmHg and ≥ 140 mmHg or Diastolic BP < 100 mmHg ≥ 90mmHg;
  • Signed informed consent.

Exclusion criteria

  • 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;
  • History of major cardiovascular or cerebrovascular events, including myocardial infarction, angina, stroke, or hospitalization for arterial revascularization;
  • Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
  • Diagnosis of malignant tumor;
  • Known allergy or history of severe adverse reactions to Coenzyme I injection or any of its components;
  • History of severe allergies or infusion reactions;
  • Women who are pregnant, breastfeeding, or planning pregnancy;
  • Severe hepatic or renal dysfunction: ALT or AST > 5 times the upper limit of normal; glomerular filtration rate ≤ 30 mL/min/1.73 m²;
  • Concurrent participation in another clinical trial without completion of the follow-up period;
  • Other conditions deemed by the investigator as unsuitable for inclusion, such as psychiatric or psychological disorders.

Treatment and study plan

Coenzyme I for Injection

Drug

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

NaCl (placebo)

Drug

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

Primary outcomes

  1. The change in flow-mediated vasodilation(FMD)

    Time frame: Day 8/28

    Changes in FMD from baseline to day 8/28.

Secondary outcomes

  1. Changes in cf-PWV.

    Time frame: day 8/28

    Changes in cf-PWV from baseline to day 8/28.

  2. Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR)

    Time frame: day 8/28

    Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR) from baseline to day 8/28.

  3. Changes in the level of NAD+

    Time frame: day 8/28

    Changes in the level of NAD+ from baseline to day 8/28.

  4. Changes in the metabolomics.

    Time frame: day 8/28

    Changes in the metabolomics from baseline to day 8/28.

  5. Changes in office blood pressure and 24-hour ambulatory blood pressure

    Time frame: day 8/28

    Changes in office blood pressure and 24-hour ambulatory blood pressure from baseline to day 8/28.

  6. The change in the urine albumin-to-creatinine ratio

    Time frame: day 8/28

    The change in the urine albumin-to-creatinine ratio from baseline to day 8/28.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Zhang

CONTACT

[email protected]

18917686332

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

A Randomized, Double-blind, Parallel Controlled Clinical Trial to Evaluate the Efficacy of Coenzyme I for Injection in the Treatment of Vascular Aging(Pilot Stydy)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.