DLBS1033 for Acute NSTEMI Without Early Coronary Revascularization

NCT ID: NCT02146664

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-03-31

Brief 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. 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.

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.

Conditions

Acute Non-ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DLBS1033

DLBS1033 enteric-coated tablet is administered at the dose of 490 mg, one tablet three times daily, everyday for eight weeks of study period

Group Type: EXPERIMENTAL

DLBS1033

Intervention Type: DRUG

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

Placebo

Placebo is administered one tablet three times daily, everyday for eight weeks of study period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

DLBS1033

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Disolf

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Munawar, SpJP(K), MD

Role: PRINCIPAL_INVESTIGATOR

Binawaluya Cardiac Hospital

Ismi Purnawan, SpJP(K), MD

Role: PRINCIPAL_INVESTIGATOR

Central Army Hospital RSPAD Gatot Soebroto

Locations

Central Army Hospital RSPAD Gatot Soebroto

Central Jakarta, Jakarta Special Capital Region, Indonesia

Binawaluya Cardiac Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

DLBS1033-0513

Identifier Type: -

Identifier Source: org_study_id