Advertisement

Topics

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

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

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.

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 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

Conditions

ST Elevation Myocardial Infarction

Intervention

DLBS1033, Placebo, Standard therapy

Location

Binawaluya Cardiac Hospital
Jakarta
Indonesia
13570

Status

Recruiting

Source

Dexa Medica Group

Results (where available)

View Results

Links

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

Clinical Trials [1475 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 [17820 Associated PubMed Articles listed on BioPortfolio]

Ischemic stroke complicating thrombolytic therapy with tenecteplase for ST elevation myocardial infarction: two case reports.

Hemorrhagic complications are quite common in the rare cases where thrombolysis is performed. Ischemic stroke in the aftermath of thrombolysis for a ST elevation myocardial infarction is a very rare a...

Optimal Antiplatelet Therapy in ST-Segment Elevation Myocardial Infarction.

Cardiovascular disease is the leading cause of death worldwide. Case-fatality rates for myocardial infarction (MI) in the United States have decreased over the past decades, in large part due to advan...

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.

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

A clinical syndrome defined by MYOCARDIAL ISCHEMIA symptoms; persistent elevation in the ST segments of the ELECTROCARDIOGRAM; and release of BIOMARKERS of myocardial NECROSIS (e.g., elevated TROPONIN levels). ST segment elevation in the ECG is often used in determining the treatment protocol (see also NON-ST ELEVATION MYOCARDIAL INFARCTION).

A myocardial infarction that does not produce elevations in the ST segments of the ELECTROCARDIOGRAM. ST segment elevation of the ECG is often used in determining the treatment protocol (see also ST Elevation Myocardial Infarction).

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.

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

Quick Search
Advertisement
 

Searches Linking to this Trial