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ST Elevation Myocardial InfarctionPhase 2/3NCT02976701

Effect of DLBS1033 After Primary PCI in Patients With STE-ACS

A Phase 2/3 study testing DLBS1033 and Standard therapy in people with ST Elevation Myocardial Infarction, run by Dexa Medica Group at 1 site in Indonesia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the study. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
DLBS1033 and Standard therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteIndonesia
Study dates
Nov 2016to Mar 2023
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

  • Signed informed consent.
  • Men or women of 30-75 years of age.
  • Evidence of acute ST elevation myocardial infarction (STEMI) at screening, as confirmed by ECG presentation of STEMI: new ST elevation at the J point in two contiguous leads with the cut-points: ≥ 0.1 mV in all leads other than leads V2-V3, where the following cut-points apply: ≥ 0.2 mV in men ≥ 40 years, ≥ 0.25 mV in men < 40 years, or ≥ 0.15 mV in women; or new or presumably new left bundle-branch block (LBBB); and with at least one of the following:
  • Positive plasma biomarkers of myocardial necrosis (cardiac troponin I [cTnI]).
  • Possible ischaemic symptoms include various combinations of chest, upper extremity, mandibular or epigastric discomfort (with exertion or at rest) or an ischaemic equivalent such as dyspnoea or fatigue.
  • The onset of the STEMI is > 3 hours before undergoing the primary PCI.
  • Therapy with study medication can be started within 24 hours after primary PCI.
  • Able to take oral medication.

Who cannot join

  • Females of childbearing potential: pregnancy, breast-feeding.
  • History of hemorrhagic stroke, serious head injury within the last 3 months.
  • History of major surgery within the last 6 months.
  • History of PCI or CABG, or previous myocardial infarction.
  • 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).
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  • Present with cardiogenic shock, 3rd degree atrioventricular (AV) block, complex anatomical coronary condition.
  • Planned for a staged PCI within 30 days after the current PCI
  • Inadequate liver function
  • CRUSADE bleeding score of > 30
  • Known or suspected allergy to other lumbrokinase products.
  • Prior experience with DLBS1033 or other oral lumbrokinase products.
  • Clinical evidence of malignancies with survival period < 1 year.
  • Any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could jeopardize patient's safety or interfere with trial participation or trial evaluation.
  • Subjects enrolled in other interventional protocol within 30 days prior to Screening
  • Any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could jeopardize patient's safety or interfere with trial participation or trial evaluation.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Binawaluya Cardiac Hospital

    Jakarta, 13570

Other trials in Indonesia

About this study

Official title: The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention

This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the study.

Read the detailed description

STE-ACS patients who undergo intermediate-delayed (> 3 hours after the onset of the STEMI) primary PCI will be enrolled in the study. Before the intervention, they will be given standard medication for PCI.

Right after PCI, all eligible subjects will be assessed for microvascular perfusion, using a pressure-temperature sensor-tipped coronary guidewire.

The day after, in addition to the dual antiplatelet therapy, i.e. 80 mg aspirin once daily and clopidogrel 75 mg once daily, DLBS1033 at a dose of 980 mg three times daily or its placebo will be given to the subjects for 4 weeks.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at Baseline (right after subjects undergo the primary PCI) and at the End of study (week 4th of DLBS1033 therapy).

Being tested
DLBS1033, Placebo, Standard therapy
Keywords
STEMI, acute coronary syndrome, DLBS1033, microvascular resistance index, Left ventricular function
Medical subject headings
ST Elevation Myocardial Infarction, Acute Coronary Syndrome

What participants receive

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

  • DLBS1033Drug

    Also called Disolf

  • PlaceboDrug

  • Standard therapyDrug

    Also called Asp-Clopi

    Standard therapy which consists of: aspirin enteric-coated tablet 1 x 80 mg and clopidogrel film-coated tablet 1 x 75 mg daily for four weeks will be given to both arms.

Study groups in NCT02976701
Study groupRoleWhat they receive
DLBS1033ExperimentalDLBS1033 enteric-coated tablet is administered at the dose of 980 mg (two tablets@490 mg) three times daily, everyday for four weeks of study period
Receives: Drug: DLBS1033; Drug: Standard therapy
PlaceboPlacebo comparatorPlacebo is administered two tablets three times daily, everyday for four weeks of study period
Receives: Drug: Placebo; Drug: Standard therapy

What is being measured

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

  1. Index of microvascular resistance (IMR)

    Improvement in the index of microvascular resistance (IMR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.

    Measured: Week 4

Secondary outcomes (10)

  1. Improvement in fractional flow reserve (FFR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire

    Improvement in fractional flow reserve (FFR) from baseline and to Week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.

    Measured: Week 4

  2. LV function

    Improvement in several parameters of left ventricular (LV) function [EF, ESV, EDV], from baseline and to Week 4th of treatment will be measured by 2D echocardiography.

    Measured: Week 4

  3. Routine hematology

    Routine hematology, including: RBC, WBC, and platelet count, will be measured at baseline and week 4th of treatment.

    Measured: Week 0 and 4

  4. Routine hematology (Hemoglobin)

    Hemoglobin will be measured at baseline and every interval of 2 weeks over the 4 weeks of treatment.

    Measured: Week 0, 2 and 4

  5. Routine hematology (Hematocrit)

    Hematocrit will be measured at baseline and every interval of 2 weeks over the 4 weeks of treatment.

    Measured: Week 0, 2 and 4

  6. Liver function

    Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), alkaline phosphatase, and total bilirubin.

    Measured: Week 0 and 4

  7. Renal function

    Renal function measured includes: serum creatinine and BUN.

    Measured: Week 0 and 4

  8. Haemostasis parameter (Prothrombin time (PT))

    Prothrombin time (PT) will be measured at baseline and every interval of 2 weeks over the 4 weeks of study treatment.

    Measured: Week 0, 2, and 4

  9. Haemostasis parameter (International Normalized Ratio (INR))

    International Normalized Ratio (INR) will be measured at baseline and every interval of 2 weeks over the 4 weeks of study treatment.

    Measured: Week 0, 2, and 4

  10. Adverse event

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

    Measured: Week 0 - 4

Timeline

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

  1. First posted29 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionJan 2023
  4. Study completionMar 2023

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02976701
Sponsor's protocol ID
DLBS1033-0716
Status last verified
Sep 2023
First submitted
21 Nov 2016
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DLBS1033 and Standard therapy in people with ST Elevation Myocardial Infarction, run by Dexa Medica Group at 1 site 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 8 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: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 stopped early (reason given: The investigational cases were no longer relevant considering the recent implementation of our current national healthcare system.). Results are not available in the source record.

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?

Index of microvascular resistance (IMR) (time frame: Week 4). 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 NCT02976701.

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 8 Sep 2023.

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