NCT03956017

Anti-oxidant Therapy and Postoperative Cardiac Events (ACE) Trial, Preoperative Intervention in Vascular Surgery

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 341 (estimated)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

N Terminal (NT)-Pro b-type natriuretic peptide (BNP) levels provide incremental value in perioperative risk assessment prior to major non-cardiac surgery. The investigators will test whether pharmacologically lowering this biomarker with daily administration of CoQ10 for 3 days prior to elective vascular surgery will reduce adverse outcomes following the operation.

Detailed description

Patients will be screened during their preoperative evaluation. Inclusion criteria include patients in need of an elective vascular operation. Exclusion criteria include urgent operation, known allergic reactions to CoQ10 and participation in another research study. Suitable participants will be randomly assigned to receive either CoQ10 (400 mg per day) versus Placebo for 3 days prior to surgery. A randomized, double blind trial will be used and a research pharmacist will guide the randomization process, blinded to clinical information. The primary end-point measures are BNP levels at 24 and 48 hours following the operation as well as the incidence of myocardial injury, defined by an elevated post-operative high-sensitivity troponin following high risk surgery. Secondary outcome measures include the magnitude of the troponin level, which is the change in the level compared with preoperative baseline troponin levels and adverse clinical cardiac outcomes during the hospitalization period, including death, non-fatal myocardial infarction, diagnosed by a cardiologist who is blinded to the treatment strategy and any coronary artery revascularization procedure. The study will be focused on 30-days following the vascular procedure but the investigators may plan to extend secondary outcome measures for 1 year post-randomization.

Conditions

• Myocardial Injury

Interventions

Type	Name	Description
DRUG	Ubiquinone	Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
DRUG	Placebo	Take oral tablets as directed (2x200 mg for 3 days prior to surgery)

Timeline

• Start date: 2013-08-05
• Primary completion: 2022-08-04
• Completion: 2022-08-04
• First posted: 2019-05-20
• Last updated: 2021-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study