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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
Sponsor:
Information provided by (Responsible Party):
Rita Zahara, National Cardiovascular Center Harapan Kita Hospital Indonesia

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?

Condition or disease Intervention/treatment Phase
Myocardial Edema Drug: Atorvastatin 80mg Drug: Atorvastatin 10mg Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. T2 relaxation time [ Time Frame: day 6 after CABG ]
    T2 relaxation time (in ms) difference between control and study group


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
Investigators
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Principal Investigator: Rita Zahara National Cardiovascular Center Harapan Kita

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Responsible Party: Rita Zahara, Cardiologist, National Cardiovascular Center Harapan Kita Hospital Indonesia
ClinicalTrials.gov Identifier: NCT02901379     History of Changes
Other Study ID Numbers: LB.02.01/VII/090/KEP.013/2016
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rita Zahara, National Cardiovascular Center Harapan Kita Hospital Indonesia:
atorvastatin
myocardial edema
Follistatin-like 1
FSTL1
atorvastatin 80mg
coronary artery bypass surgery
Additional relevant MeSH terms:
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Edema
Signs and Symptoms
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors