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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 September 2023
• Main ID: NCT02976701
• Date of registration: 21/11/2016
• Prospective Registration: No
• Primary sponsor: Dexa Medica Group
• Public title: Effect of DLBS1033 After Primary PCI in Patients With STE-ACS
• Scientific title: The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention
• Date of first enrolment: November 2016
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02976701
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Indonesia

Contacts

• Name: Muhammad Munawar, SpJP(K), MD
• Affiliation: Binawaluya Cardiac Hospital

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

ST Elevation Myocardial Infarction

Intervention(s)

Drug: DLBS1033

Drug: Placebo

Drug: Standard therapy

Primary Outcome(s)

Index of microvascular resistance (IMR) [Time Frame: Week 4]

Secondary Outcome(s)

Renal function [Time Frame: Week 0 and 4]

Routine hematology (Hematocrit) [Time Frame: Week 0, 2 and 4]

Haemostasis parameter (Prothrombin time (PT)) [Time Frame: Week 0, 2, and 4]

Haemostasis parameter (International Normalized Ratio (INR)) [Time Frame: Week 0, 2, and 4]

Routine hematology [Time Frame: Week 0 and 4]

Improvement in fractional flow reserve (FFR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire [Time Frame: Week 4]

Adverse event [Time Frame: Week 0 - 4]

Liver function [Time Frame: Week 0 and 4]

LV function [Time Frame: Week 4]

Routine hematology (Hemoglobin) [Time Frame: Week 0, 2 and 4]

Secondary ID(s)

DLBS1033-0716

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Binawaluya Cardiac Hospital