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

Sponsor

Dexa Medica Group (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02976701

Collaborator

Binawaluya Cardiac Hospital, Jakarta (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Drug: DLBS1033 Drug: Placebo Drug: Standard therapy	Phase 2/Phase 3

Detailed Description

STE-ACS patients who undergo intermediate-delayed (> 3 hours after the onset of the STEMI) primary PCI will be enrolled in the study. Before the intervention, they will be given standard medication for PCI.

Right after PCI, all eligible subjects will be assessed for microvascular perfusion, using a pressure-temperature sensor-tipped coronary guidewire.

The day after, in addition to the dual antiplatelet therapy, i.e. 80 mg aspirin once daily and clopidogrel 75 mg once daily, DLBS1033 at a dose of 980 mg three times daily or its placebo will be given to the subjects for 4 weeks.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at Baseline (right after subjects undergo the primary PCI) and at the End of study (week 4th of DLBS1033 therapy).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DLBS1033 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 Other Names: Disolf 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. Other Names: Asp-Clopi
Placebo Comparator: Placebo Placebo is administered two tablets three times daily, everyday for four weeks of study period	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. Other Names: Asp-Clopi

Arm

Intervention/Treatment

Experimental: DLBS1033

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

Other Names:

Disolf

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.

Other Names:

Asp-Clopi

Placebo Comparator: Placebo

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

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.

Other Names:

Asp-Clopi

Outcome Measures

Primary Outcome Measures

Index of microvascular resistance (IMR) [Week 4]
Improvement in the index of microvascular resistance (IMR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.

Secondary Outcome Measures

Improvement in fractional flow reserve (FFR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire [Week 4]
Improvement in fractional flow reserve (FFR) from baseline and to Week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.
LV function [Week 4]
Improvement in several parameters of left ventricular (LV) function [EF, ESV, EDV], from baseline and to Week 4th of treatment will be measured by 2D echocardiography.
Routine hematology [Week 0 and 4]
Routine hematology, including: RBC, WBC, and platelet count, will be measured at baseline and week 4th of treatment.
Routine hematology (Hemoglobin) [Week 0, 2 and 4]
Hemoglobin will be measured at baseline and every interval of 2 weeks over the 4 weeks of treatment.
Routine hematology (Hematocrit) [Week 0, 2 and 4]
Hematocrit will be measured at baseline and every interval of 2 weeks over the 4 weeks of treatment.
Liver function [Week 0 and 4]
Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), alkaline phosphatase, and total bilirubin.
Renal function [Week 0 and 4]
Renal function measured includes: serum creatinine and BUN.
Haemostasis parameter (Prothrombin time (PT)) [Week 0, 2, and 4]
Prothrombin time (PT) will be measured at baseline and every interval of 2 weeks over the 4 weeks of study treatment.
Haemostasis parameter (International Normalized Ratio (INR)) [Week 0, 2, and 4]
International Normalized Ratio (INR) will be measured at baseline and every interval of 2 weeks over the 4 weeks of study treatment.
Adverse event [Week 0 - 4]
Adverse events (especially major and minor bleeding) are observed and carefully evaluated along the course of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

KEY Inclusion Criteria:

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.

KEY Exclusion Criteria:

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
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.