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Myocardial EdemaPhase 3NCT02901379

Effect of 80-mg Atorvastatin on Myocardial Edema

A Phase 3 study testing Atorvastatin 80mg and Atorvastatin 10mg in people with Myocardial Edema, run by National Cardiovascular Center Harapan Kita Hospital Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, men only
Conditions the study is for
Myocardial Edema
What is being tested?
Atorvastatin 80mg and Atorvastatin 10mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Oct 2016to Aug 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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%
Show all 16Show fewer
  • 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

About this study

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

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?
Read the 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.

Being tested
Atorvastatin 80mg, Atorvastatin 10mg
Keywords
atorvastatin, myocardial edema, Follistatin-like 1, FSTL1, atorvastatin 80mg, coronary artery bypass surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 80mgDrug

    Also called Lipitor

    Subject will be given atorvastatin 80mg for two weeks

  • Atorvastatin 10mgDrug

    Also called Lipitor

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

Study groups in NCT02901379
Study groupRoleWhat they receive
Atorvastatin 80mgExperimentalSubjects who will receive atorvastatin 80mg for two weeks
Receives: Drug: Atorvastatin 80mg
Atorvastatin 10mgActive comparatorSubject who will receive atorvastatin 10mg
Receives: Drug: Atorvastatin 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. T2 relaxation time

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

    Measured: day 6 after CABG

Secondary outcomes (8)

  1. FSTL1 plasma level

    FSTL1 plasma level difference between control and study group

    Measured: day 6 after CABG

  2. PKA plasma level

    PKA plasma level difference between control and study group

    Measured: day 6 after CABG

  3. PKB plasma level

    PKB plasma level difference between control and study group

    Measured: day 6 after CABG

  4. hs-CRP plasma level

    hs-CRP plasma level difference between control and study group

    Measured: day 1 after CABG

  5. MDA plasma level

    MDA plasma level difference between control and study group

    Measured: day 1 after CABG

  6. Change from baseline FSTL1 plasma level

    Measured: day 1 and day 6 after CABG

  7. Change from baseline PKA plasma level

    Measured: day 1 and day 6 after CABG

  8. Change from baseline PKB plasma level

    Measured: day 1 and day 6 after CABG

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02901379
Sponsor's protocol ID
LB.02.01/VII/090/KEP.013/2016
Status last verified
Aug 2018
First submitted
6 Sep 2016
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atorvastatin 80mg and Atorvastatin 10mg in people with Myocardial Edema, run by National Cardiovascular Center Harapan Kita Hospital Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

T2 relaxation time (time frame: day 6 after CABG). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02901379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.

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