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

2016-11-30 15:45:21 | BioPortfolio


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.


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 490 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


ST Elevation Myocardial Infarction


DLBS1033, Placebo, Standard therapy


Binawaluya Cardiac Hospital




Dexa Medica Group

Results (where available)

View Results


Published on BioPortfolio: 2016-11-30T15:45:21-0500

Clinical Trials [1421 Associated Clinical Trials listed on BioPortfolio]

Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size

This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in patients with ST-elevation myocardial infarction randomized to receive cangrelor during their ...

GLP-1 on Non-ST-Segment Elevation Myocardial Infarction

We planned to evaluate the effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction (NSTEMI).

Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients With Acute Myocardial Infarction

The purpose of the IMPRESSION study is to determine whether intravenous administration of morphine prior to ticagrelor administration in ST-segment elevation myocardial infarction (STEMI) ...

MCC-135 as Adjunct Therapy to Primary Percutaneous Coronary Intervention in ST-Segment Elevation Acute Myocardial Infarction Patients

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary objectives of this study are to examine the safety, tolerability, and efficacy of intr...

ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)

Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The cur...

PubMed Articles [17716 Associated PubMed Articles listed on BioPortfolio]

Race and Sex Differences in Management and Outcomes of Patients After ST-Elevation and Non-ST-Elevation Myocardial Infarct: Results From the NCDR.

Race and sex have been shown to affect management of myocardial infarction (MI); however, it is unclear if such disparities exist in contemporary care of ST-segment elevation myocardial infarction (ST...

A System of Care for Patients With ST-Segment Elevation Myocardial Infarction in India: The Tamil Nadu-ST-Segment Elevation Myocardial Infarction Program.

Challenges to improving ST-segment elevation myocardial infarction (STEMI) care are formidable in low- to middle-income countries because of several system-level factors.

Air pollution and ST-elevation myocardial infarction: A case-crossover study of the Belgian STEMI registry 2009-2013.

Previous studies have shown that air pollution particulate matter (PM) is associated with an increased risk for myocardial infarction. The effects of air pollution on the risk of ST-elevation myocardi...

Data from the German Chest Pain Unit Registry: The well known gap between knowledge and practice.

In-hospital mortality of acute myocardial infarction with ST segment elevation remains high and is influenced by many factors, some of which are modifiable such as time to treatment initiation and mod...

Epicardial collaterals spasm as a cause of ST elevation myocardial infarction.

ST elevation myocardial infarction in a 61-year-old man with a history of previous coronary artery bypass grafts. Spasm of collaterals to the circumflex coronary artery was the cause of acute presenta...

Medical and Biotech [MESH] Definitions

MYOCARDIAL INFARCTION in which the anterior wall of the heart is involved. Anterior wall myocardial infarction is often caused by occlusion of the left anterior descending coronary artery. It can be categorized as anteroseptal or anterolateral wall myocardial infarction.

MYOCARDIAL INFARCTION in which the inferior wall of the heart is involved. It is often caused by occlusion of the right coronary artery.

Laceration or tearing of cardiac tissues appearing after MYOCARDIAL INFARCTION.

A malformation that is characterized by a muscle bridge over a segment of the CORONARY ARTERIES. Systolic contractions of the muscle bridge can lead to narrowing of coronary artery; coronary compression; MYOCARDIAL ISCHEMIA; MYOCARDIAL INFARCTION; and SUDDEN CARDIAC DEATH.

An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.

More From BioPortfolio on "Effect of DLBS1033 After Primary PCI in Patients With STE-ACS"

Quick Search

Searches Linking to this Trial