Clinical trial NCT02976701: Effect of DLBS1033 After Primary PCI in Patients With STE-ACS
Official title: The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: ST Elevation Myocardial Infarction
Keywords: STEMI
acute coronary syndrome
DLBS1033
microvascular resistance index
Left ventricular function
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
Collaborators: name: Binawaluya Cardiac Hospital
First posted: 2016-11-29
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: KEY Inclusion Criteria:

1. Signed informed consent.
2. Men or women of 30-75 years of age.
3. 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.
4. The onset of the STEMI is \> 3 hours before undergoing the primary PCI.
5. Therapy with study medication can be started within 24 hours after primary PCI.
6. Able to take oral medication.

KEY Exclusion Criteria:

1. Females of childbearing potential: pregnancy, breast-feeding.
2. History of hemorrhagic stroke, serious head injury within the last 3 months.
3. History of major surgery within the last 6 months.
4. History of PCI or CABG, or previous myocardial infarction.
5. Ongoing long term need for oral anticoagulants, antiplatelets, fibrinolytic, or antithrombotic agents, other than the study medication.
6. Having any implanted pacemaker or cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy defibrillators (CRT-D).
7. Present with cardiogenic shock, 3rd degree atrioventricular (AV) block, complex anatomical coronary condition.
8. Planned for a staged PCI within 30 days after the current PCI
9. Inadequate liver function
10. CRUSADE bleeding score of \> 30
11. Known or suspected allergy to other lumbrokinase products.
12. Prior experience with DLBS1033 or other oral lumbrokinase products.
13. Clinical evidence of malignancies with survival period \< 1 year.
14. 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.
15. Subjects enrolled in other interventional protocol within 30 days prior to Screening
16. 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.

Primary outcomes:
measure: Index of microvascular resistance (IMR)
timeFrame: Week 4
Secondary outcomes:
measure: Improvement in fractional flow reserve (FFR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire
timeFrame: Week 4
measure: LV function
timeFrame: Week 4
measure: Routine hematology
timeFrame: Week 0 and 4
measure: Routine hematology (Hemoglobin)
timeFrame: Week 0, 2 and 4
measure: Routine hematology (Hematocrit)
timeFrame: Week 0, 2 and 4
measure: Liver function
timeFrame: Week 0 and 4
measure: Renal function
timeFrame: Week 0 and 4
measure: Haemostasis parameter (Prothrombin time (PT))
timeFrame: Week 0, 2, and 4
measure: Haemostasis parameter (International Normalized Ratio (INR))
timeFrame: Week 0, 2, and 4
measure: Adverse event
timeFrame: Week 0 - 4
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Binawaluya Cardiac Hospital
Study officials:
affiliation: Binawaluya Cardiac Hospital
name: Muhammad Munawar, SpJP(K), MD
role: PRINCIPAL_INVESTIGATOR
References: