Effect Supplementation of COenzyme Q10 in Acute STEMI Underwent PPCI (ESCOMI)

Universitas Diponegoro

Status: Completed

Conditions: Coenzyme Q10; ST Segment Elevation Myocardial Infarction (STEMI)

Treatments: Drug: Coenzyme Q 10; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06661018

1648/EC/KEPK-RSDK/2023

Details and patient eligibility

About

Left ventricular remodeling can still occur after primary percutaneous coronary intervention (PCI). Global longitudinal strain (GLS) assessment has been used as a predictor of left ventricular remodeling. Coenzyme Q10 is known for its anti-inflammatory and antioxidant properties, which may help reduce cardiac remodeling. This study aims to determine the effect of CoQ10 administration after myocardial infarction as an adjunct to standard therapy on left ventricular remodeling, assessed through changes in GLS values.

Researchers will compare Coenzyme Q10 to a placebo to see if Coenzyme Q10 has a greater effect on improving left ventricular GLS values in patients with ST-Elevation Myocardial Infarction undergoing primary percutaneous coronary intervention.

Full description

This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with Acute STEMI post primary PCI who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive coenzyme Q10 100mg/12hours. Patients randomized to the other treatment group will receive a placebo. It is expected that the patients of the treatment group with the coenzyme Q10 will have a greater improvement of their GLS.

Enrollment: 46 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 21 - 80 years
• Agree to participate in the study
• Patients with a diagnosis of Acute Myocardial Infarction with ST-Segment Elevation (AMI-STE) with onset < 12 hours who underwent primary percutaneous coronary intervention (PCI)
• Successful primary PCI on the culprit lesion (residual stenosis < 20%, TIMI flow III)
• Received standard medication therapy according to guidelines (Guideline-Directed Medical Therapy; GDMT) achieved during hospitalization
• Sinus rhythm at the time of echocardiographic examination

Exclusion criteria

• Patients who routinely consume CoQ10 prior to the study
• Patients with hemodynamic conditions of Killip class III-IV and NYHA class III-IV
• Patients with a history of previous acute myocardial infarction
• Patients with a history of previous PCI or fibrinolytic therapy
• Patients with a history of previous coronary artery bypass surgery
• Patients with heart valve disease greater than moderate severity
• Patients receiving warfarin therapy
• Patients with a diagnosis of isolated right ventricular infarction
• Patients with inadequate echocardiographic image quality (poor echo window)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Group A (Oral Coenzyme Q10)

Experimental group

Description:

Experimental: Group A (Oral Coenzyme Q10) Participants who received standard treatment plus Coenzyme Q10 100 mg / 12 hours orally for up to 8 weeks. Intervention/Treatment Drug: Oral Coenzyme Q10 \* Participants will be randomized into group receiving either oral Coenzyme Q10 or placebo for up to 8 weeks

Treatment:

Drug: Coenzyme Q 10

Group B (Placebo)

Placebo Comparator group

Description:

Placebo Comparator: Group B (Placebo) Participants who received standard treatment plus Placebo / 12 hours orally for up to 8 weeks. Intervention/Treatment Drug: Placebo \* Participants will be randomized into group receiving either oral Coenzyme Q10 or placebo for up to 8 weeks.

Treatment:

Drug: Placebo