Effect of Coenzyme Q10 as an adjunct therapy versus placebo on para-clinical signs after primary angioplasty of coronary artery in acute ST-elevation myocardial infarction: a double-blind randomized clinical trial

To assess the effect of Coenzyme Q10 as an adjunct therapy versus placebo on para-clinical signs after primary angioplasty of coronary artery in acute ST-elevation myocardial infarction

This is a double-blind randomized clinical trial, in which 70 eligible patients will be randomly assigned to the intervention and control groups

The eligible patients with acute ST-elevation myocardial infarction referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.

Inclusion criteria: Age of 18 to 80 years; Myocardial ischemia for at least 30 minutes; Myocardial infarction disease in the last 12 hours; Elevated ST segment on electrocardiogram; Angioplasty for the first time; Exclusion criteria: Candidate for emergency coronary bypass surgery; History of heart attack or heart failure or angioplasty; Indication for thrombolytic therapy; Cardiogenic shock; Liver failure; Autoimmune diseases or inflammation; Taking antioxidant medicines in the past month;

Intervention group: Routine treatment plus injection of Coenzyme Q10 400 mg (manufactured by Dana pharmaceutical Co.) immediately after angioplasty and then 200 mg every 12 hours for 28 days Control group: Routine treatment plus injection of placebo (normal saline) 4 ml immediately after angioplasty and then 2 ml every 12 hours for 28 days

Primary outcome: Serum level of troponin; Serum level of CK-MB; Thrombolysis; Myocardial blushing grade; ST-segment resolution; Left ventricular ejection fraction Secondary outcome: Adverse effects (heart failure, cardiogenic shock, re-infarction, and death)

Change in duration of treatment and sample size

The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.

The medication and placebo will be injected having perfectly the same shape. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.