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

NCT02976701 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-09-08

No results posted yet for this study

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.

Conditions

  • ST Elevation Myocardial Infarction

Interventions

DRUG

DLBS1033

DRUG

Placebo

DRUG

Standard therapy

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.

Sponsors & Collaborators

  • Binawaluya Cardiac Hospital

    collaborator UNKNOWN

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

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

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
2016-11-30
Primary Completion
2023-01-31
Completion
2023-03-31

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 NCT02976701 on ClinicalTrials.gov