Ignite Creation Date:
2024-05-06 @ 9:25 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02976701
Status:
TERMINATED
Last Update Posted:
2023-09-08
First Post:
2016-11-21
Brief Title:
Effect of DLBS1033 After Primary PCI in Patients With STE-ACS
Sponsor:
Dexa Medica Group
Organization:
Dexa Medica Group
Study Overview
Official Title:
The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome STE-ACS After Primary Percutaneous Coronary Intervention
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The investigational cases were no longer relevant considering the recent implementation of our current national healthcare system
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 drugs 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
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 ie 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 drugs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None