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

NCT02976701 | Terminated Phase 2 DMC

• 1 other identifier: DLBS1033-0716
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

STEMI; acute coronary syndrome; DLBS1033; microvascular resistance index; Left ventricular function

Outcome Measures

Primary Outcomes (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.

  Week 4

Secondary Outcomes (10)

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

  Week 4

• LV function

  Week 4

• Routine hematology

  Week 0 and 4

• Routine hematology (Hemoglobin)

  Week 0, 2 and 4

• Routine hematology (Hematocrit)

  Week 0, 2 and 4

Study Arms (2)

DLBS1033

EXPERIMENTAL

DLBS1033 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

Drug: DLBS1033; Drug: Standard therapy

Placebo

PLACEBO COMPARATOR

Placebo is administered two tablets three times daily, everyday for four weeks of study period

Drug: Placebo; Drug: Standard therapy

Interventions

DLBS1033 DRUG

Also known as: Disolf

DLBS1033

Placebo DRUG

Placebo

Standard therapy DRUG

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.

Also known as: Asp-Clopi

DLBS1033; 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:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Dexa Medica Group: lead
• Binawaluya Cardiac Hospital: collaborator

Study Sites (1)

Binawaluya Cardiac Hospital

Jakarta, 13570, Indonesia

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Acute Coronary Syndrome

Interventions

DLBS 1033; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Muhammad Munawar, SpJP(K), MD

  Binawaluya Cardiac Hospital

  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: November 21, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

ID (1)