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Completed

NCT Number: NCT02901379

Effect of 80-mg Atorvastatin on Myocardial Edema

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?

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin 80mg

Drug

Subject will be given atorvastatin 80mg for two weeks

Other names: Lipitor

Atorvastatin 10mg

Drug

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

Other names: Lipitor

Primary outcomes

  1. T2 relaxation time

    Time frame: day 6 after CABG

    T2 relaxation time (in ms) difference between control and study group

Secondary outcomes

  1. FSTL1 plasma level

    Time frame: day 6 after CABG

    FSTL1 plasma level difference between control and study group

  2. PKA plasma level

    Time frame: day 6 after CABG

    PKA plasma level difference between control and study group

  3. PKB plasma level

    Time frame: day 6 after CABG

    PKB plasma level difference between control and study group

  4. hs-CRP plasma level

    Time frame: day 1 after CABG

    hs-CRP plasma level difference between control and study group

  5. MDA plasma level

    Time frame: day 1 after CABG

    MDA plasma level difference between control and study group

  6. Change from baseline FSTL1 plasma level

    Time frame: day 1 and day 6 after CABG

  7. Change from baseline PKA plasma level

    Time frame: day 1 and day 6 after CABG

  8. Change from baseline PKB plasma level

    Time frame: day 1 and day 6 after CABG

Sponsors and collaborators

Lead sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Other

Registry information

Official study title

Effect of 80-mg Atorvastatin on Myocardial Edema Following Coronary Artery Bypass Surgery in Relation With Follistatin-Like Protein-1

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2016
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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