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

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status and phase: Unknown; Early Phase 1

Conditions: Myocardial Injury

Treatments: Drug: Ubiquinone; Drug: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03956017

IND 119600 Coenzyme Q10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 341 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ELECTIVE HIGH RISK NON-CARDIAC SURGERY

Exclusion criteria

• REACTION TO COQ10

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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341 participants in 2 patient groups, including a placebo group

Ubiquinone

Experimental group

Description:

Take oral tablets as directed (2x200 mg for 3 days prior to surgery)

Treatment:

Drug: Ubiquinone

Placebo

Placebo Comparator group

Description:

Take oral tablets as directed (2x200 mg for 3 days prior to surgery)

Treatment:

Drug: Placebo