Overview

Effect of 80-mg Atorvastatin on Myocardial Edema

Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
0
Participant gender:
Male
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?
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Treatments:
Atorvastatin
Atorvastatin Calcium
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