ACUTE MYOCARDIAL INFARCTION MedDRA version: 14.1 Level: LLT Classification code 10000894 Term: Acute myocardial infarction, of anterolateral wall, initial episode of care System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: METALYSE
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: TENECTEPLASE
CAS Number: 191588-94-0
Concentration unit: IU/ml international unit(s)/millil
Sponsors
FRANCISCO JOSE MORALES PONCE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -ST-segment elevation acute myocardial infarction (STEMI) =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: -Cardiogenic shock -Previous myocardial infarction (chronic) -Sever active bleeding -Contraindications for fibrinolytics or abciximab -Contraindicaction for cardiac magnetic resonance with contrast (angio-MNR), such as metallic intracraneal implants, pacemakers, moderate-to-severe renal insufficiency) -Age under 18 -Pregnancy -Severe hepatic insufficiency -Severe diseases which can limit life expectancy under 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary angioplasty (primary PCI) is the preferred procedure to treat patients with ST- elevation acute myocardial infarction (STEMI). We sought to investigate whether, in patients with STEMI of anterior wall who are treated with standard pharmacological treatment (aspirin, a thienopiridine and heparin) and primary angioplasty, an intracoronary administration (instead of intravenous administration) of a fibrinolytic agent (tenecteplase) could be superior to that of the antiplatelet abciximab (a GP IIbIIIa platelet inhibitor) in the reduction of the final size of the myocardial infarction, on the basis of a higher efficacy of the fibrinolytic agent in the resolution of the macrovascular and microvascular obstruction by coronary thrombi;Secondary Objective: -To assess which one of both antithrombotic treatments (tenecteplase vs abciximab) is more adequate to disolve coronary thrombus when administered during primary angioplasty in STEMI patients, and to improve myocardial perfusion -To analyze whether intracoronary tenecteplase reduces the final myocardial infarction more than the antiplatelet abciximab does (as assessed with both a cardiac magnetic resonance and the ROC curve of the release of myocardial damage biochemical markers) -To evaluate the effect of both drugs on the preservation of systolic and diastolic ventricular function -To evaluate which variables (including the study drugs) are predictive of ventricular remodeling - To identify which variables are predictive of adverse outcome in these patients -To evaluate the safety of the intracoronary administration of tenecteplase, compared with the safety of intracoronary abciximab;Primary end point(s): Comparison between both treatment groups (intracoronary teneceplase group vs abciximab group) in final myocardial infarction size (as assessed with cardiac magnetic resonance with agent contrast -gadobutrol- performed 4 months after STEMI -Definition of final myocardial infarct size: mass of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ----Efficacy variables related to myocardial perfusion and ventricular function: -Electrocardiographic: Percent of ST segment elevation resolution in ECG performed 90 minutes after primary angioplasty (with respect to basal ECG, as expressed in mV and percent value) -Biochemical myocardial infarct size: Area under ROC curve of the release of CK and troponin -Angiographic: Corrected TIMI frame count, myocardial perfusion grade (myocardial blush grade, TMPG 0-3), left ventricle ejection fraction (%) -Echocardiographic (Doppler): deceleration time of mitral inflow, R/A ratio, E/E’ ratio, Tei index, end-systolic and end-diastolic left ventricle volumes, ejection fraction ---Safety variables: major cardiovascular events, and major bleeding events. -Definition of major cardiovascular events: death, new-onset myocardial infarction (chest pain plus new ST segment changes plus new CK-MB elevation), stroke or target-lesion revascularization during follow-up. -Definition of major bleeding events: those which result in death, a drop > 4 gr/dl in hemoglobin, intrapericardial effusion which results in cardiac tamponade, or any intracraneal bleeding;Timepoint(s) of evaluation of this end point: ----Efficacy variables related to myocardial perfusion and ventricular function: -Electrocardiographic: At admission and 90 minutes after primary angioplasty -Biochemical myocardial infarct size: 72 hours after STEMI onset -Angiographic: Just after primary angioplasty, and 12-24 hours later (angiographic control 12-24 hours later) -Echocardiographic (Doppler): Basal and 6 months after STEMI ---Safety variables: major cardiovascular events, and major bleeding events: At 12-month follow-up | — |
Countries
Spain
Contacts
Public ContactDIANA REGUEIRO
FUNDACION PARA LA GESTION DE LA INVESTIGACION BIOMEDICA DE CADIZ
Outcome results
None listed