Trials / Terminated
TerminatedNCT02976701
Effect of DLBS1033 After Primary PCI in Patients With STE-ACS
The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Dexa Medica Group · Industry
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DLBS1033 | |
| DRUG | Placebo | |
| DRUG | Standard therapy | Standard therapy which consists of: aspirin enteric-coated tablet 1 x 80 mg and clopidogrel film-coated tablet 1 x 75 mg daily for four weeks will be given to both arms. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2023-01-01
- Completion
- 2023-03-01
- First posted
- 2016-11-29
- Last updated
- 2023-09-08
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT02976701. Inclusion in this directory is not an endorsement.