Effect Supplementation of COenzyme Q10 in Acute STEMI Underwent PPCI

NCT ID: NCT06661018

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-28
• Study Completion Date: 2024-06-30

Brief Summary

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.

Detailed 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.

Conditions

ST Segment Elevation Myocardial Infarction (STEMI); Coenzyme Q10

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A (Oral Coenzyme Q10)

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

Group Type: EXPERIMENTAL

Coenzyme Q 10

Intervention Type: DRUG

participant will receive STEMI standard treatment plus oral Coenzyme Q10 (chewable tablet) 100 mg / 12 hours for 8 weeks

Group B (Placebo)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

participant will receive STEMI standard treatment plus placebo /12 hours for 8 weeks

Interventions

Coenzyme Q 10

participant will receive STEMI standard treatment plus oral Coenzyme Q10 (chewable tablet) 100 mg / 12 hours for 8 weeks

Intervention Type: DRUG

Placebo

participant will receive STEMI standard treatment plus placebo /12 hours for 8 weeks

Intervention Type: DRUG

Other Intervention Names

CoQ10; ubiquinone

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Diponegoro

OTHER

Sponsor Role: lead

Responsible Party

Ilham Uddin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilham Uddin, Medical Doctor, cardiologist

Role: PRINCIPAL_INVESTIGATOR

University of Diponegoro

Locations

Dr. Kariadi Central General Hospital

Semarang, Central Java, Indonesia

Dr. Kariadi Central General Hospital

Semarang, Central Java, Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1648/EC/KEPK-RSDK/2023

Identifier Type: -

Identifier Source: org_study_id