Effect of DLBS1033 After Primary PCI in Patients With STE-ACS (NCT02976701) | Clinical Trial Compass
TerminatedPhase 2/3
Effect of DLBS1033 After Primary PCI in Patients With STE-ACS
Stopped: The investigational cases were no longer relevant considering the recent implementation of our current national healthcare system.
Indonesia23 participantsStarted 2016-11
Plain-language 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.
Who can participate
Age range30 Years – 75 Years
SexALL
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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:
✓. 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.
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).