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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group
• Collaborator: Binawaluya Cardiac Hospital, Jakarta

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