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DLBS1033 for Acute NSTEMI Without Early Coronary Revascularization

NCT02146664 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2016-04-20

No results posted yet for this study

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

Interventions

DRUG

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

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

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Muhammad Munawar, SpJP(K), MD · Binawaluya Cardiac Hospital

  • Ismi Purnawan, SpJP(K), MD · Central Army Hospital RSPAD Gatot Soebroto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2018-03-31

Countries

  • Indonesia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02146664 on ClinicalTrials.gov