Coenzyme Q10 for Acute Stanford Type A Aortic Dissection: Protocol for a Prospective, Randomized, Double-Blind,...

Background/Objectives: Acute Stanford type A aortic dissection (TAAD) is a catastrophic cardiovascular emergency. Emergency surgery is the standard life-saving treatment, but some patients decline operative repair, and no established pharmacological therapy has been shown to stabilize acute TAAD. Preclinical work by our team implicates mitochondrial dysfunction and smooth muscle cell phenotypic switching in aortic dissection and suggests that coenzyme Q10 may reduce dissection-related injury. This study aims to determine the feasibility of a future definitive randomized trial and to obtain preliminary safety and exploratory efficacy information. Methods: This prospective, randomized, double-blind, placebo-controlled, single-center feasibility trial will enroll 60 adults with CTA-confirmed Stanford type A aortic dissection within 24 h of symptom onset who decline emergency surgical repair after standard surgical counseling. Participants will be randomized 1:1 to oral coenzyme Q10 100 mg three times daily or matched placebo for 14 days, in addition to the same guideline-directed supportive medical care. The primary feasibility outcome is recruitment feasibility, defined as randomization of 60 participants within 12 months after recruitment initiation. Secondary feasibility outcomes include treatment adherence, follow-up completion, dropout, missingness, outcome-assessment feasibility, and candidate endpoint event rates. The primary exploratory clinical outcome is 14-day all-cause mortality; additional exploratory outcomes include aortic rupture death, false-lumen thrombosis, cardiac tamponade, worsening pericardial effusion, and organ malperfusion syndromes. Safety outcomes include adverse events, serious adverse events, adverse drug reactions, suspected unexpected serious adverse reactions, and prespecified laboratory indices. Results: The trial is designed to establish whether recruitment, blinded treatment delivery, follow-up, outcome collection, and safety monitoring are operationally feasible and to provide estimates for planning a larger confirmatory trial. Conclusions: This feasibility trial will inform the design and conduct of future definitive evaluation of coenzyme Q10 in acute TAAD. Trial registration: Chinese Clinical Trial Registry, ChiCTR2600123230.