Effect of 80-mg Atorvastatin on Myocardial Edema

NCT ID: NCT02901379

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-08-31

Brief Summary

The purpose of this study is to determine whether atorvastatin 80mg can reduce the development of myocardial edema following coronary artery bypass surgery.

This study also want to determine:

1. whether atorvastatin 80mg can influence Follistatin-like 1 (FSTL1) plasma level following bypass surgery?

2. whether there is correlation between myocardial edema and FSTL1 plasma level?

3. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in reducing hs-CRP (high sensitive-C reactive protein) and MDA (malondialdehyde) plasma level following bypass surgery?

4. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in raising PKA and PKB plasma level following bypass surgery?

Detailed Description

This study is an double blinded experimental study using parallel design. Study subjects are patients in Harapan Kita hospital who are registered to CABG (Coronary Artery Bypass Graft) surgery and fulfill all the eligibility criteria.

The subjects will be first consecutively selected, with male age 40-65 as the criteria. After that the investigators do the randomization with block randomization method. All the subjects will be given drug with label A and label B (only the pharmacist know the which dose of atorvastatin belong to which label).

Total subjects needed for this study are 30 (15 belong to study group and 15 belong to control group) MRI (Magnetic Resonance Imaging) results will be read by two radiologists, and analyzed using cronbach alpha. The results are considered equal if the cronbach >0,7. If it is proven to be unequal, then the third radiologist will decide.

Statin is known to have several adverse effects, such as myopathy, myositis to rhabdomyolysis, elevated liver enzyme, memory loss, GI (gastrointestinal) disturbance, and severa others. Therefore, the investigators will check baseline CK (creatine kinase) and liver enzyme at the beginning of the study, before the surgery, and if the patient feel any symptoms. Statin will be stopped if patient decide to stop, or if there is increase in ALT (alanine aminotransferase) higher that three time upper normal value, or if there is increase in CK higher than ten times upper normal value.

Statistical analysis using IBM SPSS statistics version 21.0. Comparative analysis for variables such as smoking history, obesity, hypertension, dyslipidemia, diabetes, family history, infarct history, ACE-I/ARB (angiotensin converting enzyme inihibitor /angiotensin receptor blocker) therapy will be using chi-square or fischer. Comparative analysis for variables T2 relaxation time, FSTL1, hs-CRP, PKA (protein kinase A), PKB (Protein Kinase B), MDA, age, CPB (Cardiopulmonary Bypass) time, CABG time will using unpaired t-test or Mann-whitney. Correlative analysis between FSTL1 and T2 relaxation time will be using Pearson test.

Conditions

Myocardial Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Atorvastatin 80mg

Subjects who will receive atorvastatin 80mg for two weeks

Group Type: EXPERIMENTAL

Atorvastatin 80mg

Intervention Type: DRUG

Subject will be given atorvastatin 80mg for two weeks

Atorvastatin 10mg

Subject who will receive atorvastatin 10mg

Group Type: ACTIVE_COMPARATOR

Atorvastatin 10mg

Intervention Type: DRUG

Subjects will be give atorvastatin 10mg as part of standard therapy in hospital

Interventions

Atorvastatin 80mg

Subject will be given atorvastatin 80mg for two weeks

Intervention Type: DRUG

Atorvastatin 10mg

Subjects will be give atorvastatin 10mg as part of standard therapy in hospital

Intervention Type: DRUG

Other Intervention Names

Lipitor; Lipitor

Eligibility Criteria

Inclusion Criteria

• Patients with coronary artery disease indicated for CABG surgery
• has signed informed consent

Exclusion Criteria

• high risk EURO (European System for Cardiac Operative Risk Evaluation) score
• creatinin value>2 g/dl
• direct bilirubin value >3 mg/ml
• AST/ALT (aspartate transaminase / alanine transaminase) value >1,5 times UNL (upper normal limit)
• high pre-operative CKMB (Creatine Kinase-MB) and troponin
• LVEF (Left Ventricular Ejection Fraction) <45%
• concomitant valve disease required surgery
• contraindicated for MRI
• high degree ventricular arrhytmia
• coagulation disorder
• COPD (chronic obsructive pulmonary disease)
• HIV (Human Immunodeficiency Virus) +, HBV (Hepatitis B Virus)+, HCV (Hepatitis C Virus) +
• conduction abnormality, pacemaker
• electrolyte or blood gas disturbance
• receiving immunosuppressive drug or cytotoxic agent 4 weeks before surgery
• receiving macrolide, azole antifungal, fibrate, or protease inhibitor HIV drug

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role: lead

Responsible Party

Rita Zahara

Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita Zahara

Role: PRINCIPAL_INVESTIGATOR

National Cardiovascular Center Harapan Kita

Other Identifiers

LB.02.01/VII/090/KEP.013/2016

Identifier Type: -

Identifier Source: org_study_id