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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03956017
Other study ID # IND 119600 Coenzyme Q10
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date August 5, 2013
Est. completion date August 4, 2022

Study information

Verified date August 2021
Source Minneapolis Veterans Affairs Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 341
Est. completion date August 4, 2022
Est. primary completion date August 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - ELECTIVE HIGH RISK NON-CARDIAC SURGERY Exclusion Criteria: - REACTION TO COQ10

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Va Medical Center Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary BNP levels following surgery Peak values 48 hours
Primary Cardiac Troponin levels following surgery Peak values 48 hours
Primary Change in Troponin levels from baseline to peak Change from baseline to peak 48 hours
Primary Number of participants with adverse cardiac outcomes following surgery Myocardial Infarction (MI) and death 48 hours
Secondary Number of participants who died All cause mortality 30 days
Secondary Number of participants requiring coronary revascularization Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) 30 days
Secondary Number of participants with new heart failure Heart failure, newly diagnosed by cardiologist 30 days
Secondary Number of participants with new onset Atrial Fibrillation (A-Fib) New onset A-Fib 30 days
Secondary Number of participants with infection Infection diagnosed by a primary care provider 30 days
Secondary Number of participants with a surgical graft failure Primary surgical site graft failure 30 days
Secondary Length of stay Length of stay in days for index hospitalization 30 days
Secondary Rate of readmission at 1 year following discharge Any admission to hospital for 1 year post discharge 1 year
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