ST-elevation myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction
Conditions
Interventions
Trade Name: ReoPro
Product Name: ReoPro
Pharmaceutical Form: Irrigation solution
INN or Proposed INN: ABCIXIMAB
CAS Number: 143653-53-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) >= 18 years of age 2) ST-elevation myocardial infarction, characterized by: a)Clinical symptoms: Angina pectoris 30 minutes b) ECG-criteria in 12-lead ECG: ST-segment elevation > 1mm in = 2 extremity leads and / or ST-segment elevation > 2mm in = 2 adjacent precordial leads 3) written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Known drug hypersensitivity to Abciximab, other components of the trial medication or murine monoclonal antibodies 2) Known drug hypersensitivity to ASS or heparin 3) Active peptic ulcus ventriculi or duodeni 4) Major surgical interventions, lithotripsy, intracranial / intraspinal interventions or puncture of a not sufficiently compressible vessel less than eight weeks before start of trial 5) Intracranial tumors 6) Active internal bleeding 7) Cerebrovascular complications less than 2 years befor start of trial 8) Known coagulation defect or thrombocytopenia 9) Arteriovenous malformations or aneurysm 10) Severe liver or renal insufficiency (creatinin clearence < 30 ml/min) 11) Uncontrolled hypertension, hypertensive retinopathy 12) Vasculitis 13) Previous thrombolysis (less than 12 hrs ago) 14) Lacking compliance 15) Pregnant or nursing women 16) Fertile female patients (< 2 years post their last menstruation) without using appropriate contraception (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) during trial participation 17) Participation in another interventional trial Additional exclusion criteria for the MRT substudy: 1) Severe claustrophobia 2) Hemodynamic instability 3) Pacemaker or internal cardioverter defibrillator (ICD) 4) Metallic cerebral or intracranial implants 5) Known frug hypersensitivity to Gadolinium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure;Secondary Objective: Key secondary endpoint(s) evaluating the efficacy of the trial therapy: ST-segment resolution 90 minute ECG; TIMI-flow post PCI; indirect infarct size by enzyme release; individual clinical endpoints;Primary end point(s): Combined clinical endpoint at 90 days consisting of mortality, reinfarction, and new congestive heart failure. | — |
Countries
Germany
Outcome results
None listed