Effect of 80-mg Atorvastatin on Myocardial Edema

NCT02901379 | Completed Phase 3 DMC

• 1 other identifier: LB.02.01/VII/090/KEP.013/2016
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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. 1.whether atorvastatin 80mg can influence Follistatin-like 1 (FSTL1) plasma level following bypass surgery?
2. 2.whether there is correlation between myocardial edema and FSTL1 plasma level?
3. 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. 4.the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in raising PKA and PKB plasma level following bypass surgery?

Conditions

Myocardial Edema

Keywords

atorvastatin; myocardial edema; Follistatin-like 1; FSTL1; atorvastatin 80mg; coronary artery bypass surgery

Outcome Measures

Primary Outcomes (1)

• T2 relaxation time

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

  day 6 after CABG

Secondary Outcomes (8)

• FSTL1 plasma level

  day 6 after CABG

• PKA plasma level

  day 6 after CABG

• PKB plasma level

  day 6 after CABG

• hs-CRP plasma level

  day 1 after CABG

• MDA plasma level

  day 1 after CABG

Study Arms (2)

Atorvastatin 80mg

EXPERIMENTAL

Subjects who will receive atorvastatin 80mg for two weeks

Drug: Atorvastatin 80mg

Atorvastatin 10mg

ACTIVE COMPARATOR

Subject who will receive atorvastatin 10mg

Drug: Atorvastatin 10mg

Interventions

Atorvastatin 80mg DRUG

Subject will be given atorvastatin 80mg for two weeks

Also known as: Lipitor

Atorvastatin 80mg

Atorvastatin 10mg DRUG

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

Also known as: Lipitor

Atorvastatin 10mg

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with coronary artery disease indicated for CABG surgery
• has signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Rita Zahara

  National Cardiovascular Center Harapan Kita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 15, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share