A Phase 3 interventional study of Atorvastatin 80mg and Atorvastatin 10mg in Myocardial Edema, sponsored by National Cardiovascular Center Harapan Kita Hospital Indonesia. Completed. Open to male participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-23.
Sponsored by National Cardiovascular Center Harapan Kita Hospital Indonesia · Phase 3, Interventional, and Prevention
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:
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.
National Cardiovascular Center Harapan Kita Hospital Indonesia is the lead sponsor of 25 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects who will receive atorvastatin 80mg for two weeks
Drug: Atorvastatin 80mg
Subject who will receive atorvastatin 10mg
Drug: Atorvastatin 10mg
Subject will be given atorvastatin 80mg for two weeks
Also known as: Lipitor
Subjects will be give atorvastatin 10mg as part of standard therapy in hospital
Also known as: Lipitor
T2 relaxation time
T2 relaxation time (in ms) difference between control and study group
Time frame: day 6 after CABG
FSTL1 plasma level
FSTL1 plasma level difference between control and study group
Time frame: day 6 after CABG
PKA plasma level
PKA plasma level difference between control and study group
Time frame: day 6 after CABG
PKB plasma level
PKB plasma level difference between control and study group
Time frame: day 6 after CABG
hs-CRP plasma level
hs-CRP plasma level difference between control and study group
Time frame: day 1 after CABG
MDA plasma level
MDA plasma level difference between control and study group
Time frame: day 1 after CABG
Change from baseline FSTL1 plasma level
Time frame: day 1 and day 6 after CABG
Change from baseline PKA plasma level
Time frame: day 1 and day 6 after CABG
Change from baseline PKB plasma level
Time frame: day 1 and day 6 after CABG
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atorvastatin
National Cardiovascular Center Harapan Kita Hospital Indonesia