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

Official 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）

Overview

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.

Interventions

• Drug Coenzyme I for Injection
  Subjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection.
• Drug NaCl (placebo)
  Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%).

Primary outcome measures

• The change in flow-mediated vasodilation(FMD) [Time frame: Day 8/28]

Secondary outcome measures (6)

• Changes in cf-PWV. [Time frame: day 8/28]
• Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR) [Time frame: day 8/28]
• Changes in the level of NAD+ [Time frame: day 8/28]
• Changes in the metabolomics. [Time frame: day 8/28]
• Changes in office blood pressure and 24-hour ambulatory blood pressure [Time frame: day 8/28]
• The change in the urine albumin-to-creatinine ratio [Time frame: day 8/28]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Tenth People's Hospital — Shanghai

Identifiers

NCT: NCT07328100 · NAD-VA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗