Track topics on Twitter Track topics that are important to you
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 intravenous MCC-135 in limiting final infarct size, as measured by single photon emission computed tomography (SPECT), in patients who require percutaneous coronary intervention (PCI) for a first-documented ST-segment elevation acute myocardial infarction (AMI).
Patients will be male or female aged 18 years and older who present to the emergency room (ER) < 6 hours from onset of AMI symptoms. The AMI must be confirmed by a 12-lead electrocardiogram (ECG) and documented in at least 2 leads. Each potential patient must be a candidate for primary PCI and not have thrombolytic therapy planned. To be eligible, patients must not have a prior history of ST-segment elevation MI.
Patients will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups: A, B, and C. Group A will receive MCC-135 4.5 mg/kg/48 hours; Group B will receive MCC-135 9.0 mg/kg/48 hours; and Group C will receive placebo/48 hours. Three hundred thirty patients with a TIMI flow grade of 0/1 are required to complete the study. Because patients will be enrolled and will receive study medication prior to assessment of TIMI flow, it is expected that at least 414 patients may need to be randomized in order to obtain the required 330 qualified patients. All randomized patients will receive 48 hours of study medication, with ongoing assessments during this period, and will have follow-up assessments on Days 3, 4, 5, 30, and 180 as described below, regardless of preoperative TIMI flow grade.
Following initial physical examination, vital signs, establishment of a separate and dedicated IV access, baseline blood sampling, and confirmation of all study eligibility requirements, patients will be randomized and begin receiving study drug as an adjunct to standard therapy. Patients will begin study drug infusion as soon as possible, but < 6 hours following onset of AMI symptoms (i.e., symptoms of myocardial ischemia). Examples of ischemic symptoms include chest, arm, and/or jaw pain, shortness of breath, nausea, diaphoresis, or other symptoms that the investigator considers to be of ischemic origin. A negative result from a urine pregnancy test must be obtained for females of childbearing potential prior to the start of study drug infusion.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Massachusetts General Hospital/ Harvard Medical School
Mitsubishi Tanabe Pharma Corporation
Published on BioPortfolio: 2014-07-23T21:52:07-0400
Long-term beta-blocker therapy has not been investigated in contemporary randomized clinical trials in patients with myocardial infarction and normal heart function. The aim of this study ...
ST-elevation myocardial infarction is a major cause of morbidity and mortality worldwide. ST-elevation myocardial infarction damages the regional myocardium that undergoes ischemia and nec...
This is a multicenter retrospective observational study with STEMI (ST Elevation Myocardial Infarction) patients who have been treated in the northern Galician Hospitals. The study tries t...
Prospective cohort evaluating patients in the State of Santa Catarina (Brazil) with the diagnosis of the first acute myocardial infarction from July 2016 until December 2020.
Recent clinical studies have shown that systemic therapeutic hypothermia improving the outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary percutan...
First, describe how acute myocardial infarction criteria are used to diagnose type 1 (T1MI) and 2 (T2MI) myocardial infarction. Second, determine whether subjective or objective criteria are used for ...
After the introduction of the universal definition of myocardial infarction, the incidence and diagnosis of type 2 myocardial infarction have risen dramatically, yet there are no clear guidelines on c...
The intensity of the inflammatory response and hemodynamic repercussion in acute myocardial infarction causing the presence in the peripheral circulation of nucleated red blood cells (NRBCs), increase...
Primary percutaneous coronary intervention (pPCI) is recommended in patients presenting with ST-elevation myocardial infarction (STEMI) within
A 68-year-old man with a non-ST elevation myocardial infarction (NSTEMI) presented with a low risk profile indicating invasive revascularization within 72 h. However, left ventricular (LV) global long...
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.
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).
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).
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.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...