Effect of 80-mg Atorvastatin on Myocardial Edema
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|ClinicalTrials.gov Identifier: NCT02901379|
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : August 23, 2018
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:
- whether atorvastatin 80mg can influence Follistatin-like 1 (FSTL1) plasma level following bypass surgery?
- whether there is correlation between myocardial edema and FSTL1 plasma level?
- 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?
- the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in raising PKA and PKB plasma level following bypass surgery?
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Edema||Drug: Atorvastatin 80mg Drug: Atorvastatin 10mg||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of 80-mg Atorvastatin on Myocardial Edema Following Coronary Artery Bypass Surgery in Relation With Follistatin-Like Protein-1|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Experimental: Atorvastatin 80mg
Subjects who will receive atorvastatin 80mg for two weeks
Drug: Atorvastatin 80mg
Subject will be given atorvastatin 80mg for two weeks
Other Name: Lipitor
Active Comparator: Atorvastatin 10mg
Subject who will receive atorvastatin 10mg
Drug: Atorvastatin 10mg
Subjects will be give atorvastatin 10mg as part of standard therapy in hospital
Other Name: Lipitor
- T2 relaxation time [ Time Frame: day 6 after CABG ]T2 relaxation time (in ms) difference between control and study group
- FSTL1 plasma level [ Time Frame: day 6 after CABG ]FSTL1 plasma level difference between control and study group
- PKA plasma level [ Time Frame: day 6 after CABG ]PKA plasma level difference between control and study group
- PKB plasma level [ Time Frame: day 6 after CABG ]PKB plasma level difference between control and study group
- hs-CRP plasma level [ Time Frame: day 1 after CABG ]hs-CRP plasma level difference between control and study group
- MDA plasma level [ Time Frame: day 1 after CABG ]MDA plasma level difference between control and study group
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901379
|Principal Investigator:||Rita Zahara||National Cardiovascular Center Harapan Kita|