DLBS1033 for Acute NSTEMI Without Early Coronary Revascularization

NCT02146664 | Withdrawn Phase 2 DMC

• 1 other identifier: DLBS1033-0513
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Non-ST Elevation Myocardial Infarction

Keywords

Acute NSTEMI; DLBS1033; SPECT; Infarct size; Left ventricular function

Outcome Measures

Primary Outcomes (1)

• Infarct size

  The quantitative change of infarct size, measured using SPECT.

  Week 0, week 8, week 24

Secondary Outcomes (12)

• LV function

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

• Composite endpoints

  Week 0 - 24

• Individual event of MACE and other cardiovascular events

  Week 0 - 24

• Nitroglycerin amount

  Week 0 - 24

• Plasma fibrinogen level

  Week 0, 4, 8, and 24

Study Arms (2)

DLBS1033

EXPERIMENTAL

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

Drug: DLBS1033

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DLBS1033 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

Also known as: Disolf

DLBS1033

Placebo 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

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (2)

Central Army Hospital RSPAD Gatot Soebroto

Central Jakarta, Jakarta Special Capital Region, Indonesia

Location

Binawaluya Cardiac Hospital

Jakarta, Jakarta Special Capital Region, 13570, Indonesia

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

DLBS 1033

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Muhammad Munawar, SpJP(K), MD

  Binawaluya Cardiac Hospital

  PRINCIPAL INVESTIGATOR

• Ismi Purnawan, SpJP(K), MD

  Central Army Hospital RSPAD Gatot Soebroto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 26, 2014
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

ID (2)