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Acute Non-ST Elevation Myocardial InfarctionPhase 2/3NCT02146664

DLBS1033 for Acute NSTEMI Without Early Coronary Revascularization

A Phase 2/3 study testing DLBS1033 in people with Acute Non-ST Elevation Myocardial Infarction, run by Dexa Medica Group at 2 sites in Indonesia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without early coronary revascularization. Read more about this study

Who is it for?
Ages 30 to 75 years
What is being tested?
DLBS1033
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesIndonesia
Study dates
Nov 2015to Mar 2018
Phase
Phase 2/3
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women of 30-75 years of age.
  • Evidence of acute non-ST elevation myocardial infarction (NSTEMI) at screening, as confirmed by all of the following:
  • ECG transient ST-segment deviation/depression (≥ 1 mm) or prominent T-wave inversion, in multiple precordial leads;
  • Positive plasma biomarkers of myocardial necrosis: cardiac troponin I (cTnI);
  • Clinical symptoms of chest discomfort/pain or anginal equivalent (dyspnea, diaphoresis, excessive vomiting in diabetic patients and arm or jaw pain).
  • High risk subjects, defined as having Thrombolysis in Myocardial Infarction (TIMI) score ≥ 4
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  • Subjects refuse to undergo reperfusion therapies, such as coronary artery-bypass surgery (CABG) or percutaneous coronary intervention (PCI) within the next six months.
  • Therapy with study medication can be started within 7 days after first presentation in the hospital.
  • Able to take oral medication.

Who cannot join

  • For females of childbearing potential: pregnancy, breast-feeding, the intention of becoming pregnant.
  • ECG presentation of STEMI.
  • History of hemorrhagic stroke within the last 3 months.
  • Patients with seizure at the onset of stroke or with regular medication for seizure/epilepsy.
  • History of serious head injury within the last 3 months.
  • History of major surgery within the last 3 months.
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  • Ongoing long term need for oral anticoagulants, antiplatelets, fibrinolytic, or antithrombotic agents, other than the study medication.
  • Having any implanted pacemaker or cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy defibrillators (CRT-D).
  • Clinically significant arrhythmias or atrioventricular conduction block greater than first degree.
  • Acute or chronic heart failure as defined by the New York Heart Association (NYHA) classification as functional Class IV.
  • Known severe LV dysfunction (EF ≤ 40 and EDD > 55 mm).
  • Inadequate liver function: ALT > 3 times upper limit of normal (ULN).
  • Inadequate renal function: serum creatinine ≥ 1.5 times upper limit of normal (ULN).
  • Uncontrolled hypertension (SBP > 185 mmHg or DBP > 110 mmHg).
  • Random plasma glucose ≥ 180 mg/dL and HbA1c ≥ 7.0% at Screening.
  • Moderate to high risk of bleeding, defined as those who have the CRUSADE bleeding score of > 30.
  • Known or suspected allergy to any of study medications used in the study, including other lumbrokinase products.
  • Prior experience with DLBS1033 or other oral lumbrokinase products.
  • Clinical evidence of malignancies with survival period < 1 year.
  • Any other disease which judged by the investigator could interfere with trial participation or trial evaluation.
  • Enrolled in other interventional protocol within 30 days prior to Screening.

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Central Army Hospital RSPAD Gatot Soebroto

    Central Jakarta, Jakarta Special Capital Region

  • Binawaluya Cardiac Hospital

    Jakarta, Jakarta Special Capital Region, 13570

Other trials in Indonesia

About this study

Official title: The Role of DLBS1033 in The Management of Acute Non-ST Elevation of Myocardial Infarction (NSTEMI) Without Early Coronary Revascularization

This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without early coronary revascularization. It is hypothesized that the combination of DLBS1033 with aspirin and clopidogrel will result in greater reduction of infarct size in comparison with that of aspirin and clopidogrel alone.

Read the detailed description

After diagnosed NSTEMI, patient is hospitalized and given medications according to the standard management of acute NSTEMI, including anticoagulant low molecular weight heparin. Eligible subjects are then randomized to receive either DLBS1033 at a dose of 490 mg three times daily or its placebo in addition to clopidogrel 75 mg once daily and aspirin 160 mg once daily for an 8-week course of therapy. Afterwards, the administration of DLBS1033 and its placebo are stopped, while the dual antiplatelet therapy (aspirin and clopidogrel) remains for another 16 weeks at the same dose regimen as the previous.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety are performed at baseline, week 4, week 8, and week 24. To guard the safety of the study subjects, haemostasis parameters, hematology parameters, and CRUSADE bleeding score are evaluated every two-week-interval over the first eight weeks of treatment.

Being tested
DLBS1033, Placebo
Keywords
Acute NSTEMI, DLBS1033, SPECT, Infarct size, Left ventricular function
Medical subject headings
Non-ST Elevated Myocardial Infarction

What participants receive

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

  • DLBS1033Drug

    Also called Disolf

    Investigational drug or placebo will be given in addition to the standard therapy which consists of: aspirin enteric-coated tablet 1 x 160 mg (two tablets @ 80 mg) and clopidogrel film-coated tablet 1 x 75 mg daily for eight weeks. Standard therapy alone will still be given afterwards, for another sixteen weeks

  • PlaceboDrug

    Investigational drug or placebo will be given in addition to the standard therapy which consists of: aspirin enteric-coated tablet 1 x 160 mg (two tablets @ 80 mg) and clopidogrel film-coated tablet 1 x 75 mg daily for eight weeks. Standard therapy alone will still be given afterwards, for another sixteen weeks

Study groups in NCT02146664
Study groupRoleWhat they receive
DLBS1033ExperimentalDLBS1033 enteric-coated tablet is administered at the dose of 490 mg, one tablet three times daily, everyday for eight weeks of study period
Receives: Drug: DLBS1033
PlaceboPlacebo comparatorPlacebo is administered one tablet three times daily, everyday for eight weeks of study period
Receives: Drug: Placebo

What is being measured

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

  1. Infarct size

    The quantitative change of infarct size, measured using SPECT.

    Measured: Week 0, week 8, week 24

Secondary outcomes (12)

  1. LV function

    Improvement in left ventricular (LV) function, measured by 2D echocardiography.

    Measured: Week 0, week 4, week 8, and week 24

  2. Composite endpoints

    Composite endpoints (composite of major adverse cardiovascular events), comprising of all-cause of death, recurrent myocardial infarction or ischemic stroke within the study period.

    Measured: Week 0 - 24

  3. Individual event of MACE and other cardiovascular events

    Individual event of MACE and other cardiovascular events, such as: shock, pulmonary oedema, congestive heart failure, arrhythmias, hemodynamic instability/cardiogenic shock, including the presence of new infarct(s) within the study period.

    Measured: Week 0 - 24

  4. Nitroglycerin amount

    Number of nitroglycerin (rescue medicine) taken during the study period.

    Measured: Week 0 - 24

  5. Plasma fibrinogen level

    Change in plasma fibrinogen level.

    Measured: Week 0, 4, 8, and 24

  6. Plasma d-dimer level

    Change in plasma d-dimer level.

    Measured: Week 0, 4, 8, and 24

  7. hs-CRP

    Change in hs-CRP.

    Measured: Week 0, 4, 8, and 24

  8. Routine hematology

    Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count. Particularly for hemoglobin and hematocrit level, they are measured at baseline and every interval of 2 weeks over the first 8 weeks of treatment and at the end of study (week 24).

    Measured: Week 0, 4, 8, and 24

  9. Liver function

    Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), alkaline phosphatase, and total bilirubin. Particularly for serum ALT, it is measured at baseline and every interval of 2 weeks over the first 8 weeks of treatment and at the end of study (week 24).

    Measured: Week 0, 4, 8, and 24

  10. Renal function

    Renal function measured includes: serum creatinine and BUN. Particularly for serum creatinine, it is measured at baseline and every interval of 2 weeks over the first 8 weeks of treatment and at the end of study (week 24).

    Measured: Week 0, 4, 8, and 24

  11. Haemostasis parameter

    Haemostasis parameter measured includes: prothrombin time (PT), International Normalized Ratio (INR), and activated partial thromboplastin time (aPTT). Particularly for PT and INR, they are measured at baseline and every interval of 2 weeks over the first 8 weeks of treatment and at the end of study (week 24).

    Measured: Week 0, 4, 8, and 24

  12. Adverse event

    Adverse events (especially major and minor bleeding) are observed and carefully evaluated along the course of the study.

    Measured: Week 0 - 24

Timeline

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

  1. First posted26 May 2014 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2017 (estimated)
  4. Study completionMar 2018 (estimated)

Why it stopped: The investigational cases were no longer relevant considering the recent implementation of our current national healthcare system.

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146664
Sponsor's protocol ID
DLBS1033-0513
Status last verified
Apr 2016
First submitted
13 May 2014
Last updated
20 Apr 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DLBS1033 in people with Acute Non-ST Elevation Myocardial Infarction, run by Dexa Medica Group at 2 sites in 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 9 inclusion and 21 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: withdrawn, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Infarct size (time frame: Week 0, week 8, week 24). 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 NCT02146664.

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 20 Apr 2016.

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