Myocardial infarction <= 12 hours MedDRA version: 15.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: prasugrel
Product Code: prasugrel
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PRASUGREL
CAS Number: 150322-43-3
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Stiftung Institut für Herzinfarktforschung
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >= 18years and =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: Age >= 75years Body weight < 60kg Thrombolytic therapy within 24hrs before randomization Oral anticoagulation Known hemorrhagic diathesis History of stroke or TIA Cardiogenic shock Evidence of active gastrointestinal or urogenital bleeding Major surgery within 6 weeks Contraindication to prasugrel or clopidogrel Severe renal or hepatic insufficiency Contraindication to coronary angiography Planned administration of GP IIb/IIIa inhibitor before angiography Pregnant or nursing women Patients currently treated with clopidogrel, prasugrel, ticlopidine, or ticagrelor Uncontrollable hypertension (blood pressure = 200/110 mmHg in repeated measurements) Treatment with NSAIDs Participation in another clinical or device trial within previous 30 days Expected time between administration of loading dose and start of PCI is < 20 minutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Inhibition of platelet aggregation by prasugrel and clopidogrel, assessed by the platelet reactivity index (PRI) 2 hrs. after initiation of therapy.;Secondary Objective: PRI 4 hrs. after initiation of therapy Rate of complete ST segement resolution 60min after PCI TIMI 2/3 patency of infarct related artery prior to PCI TIMI 3 patency before PCI TIMI 3 patency after PCI ST resolution before angiography Partial or no ST resolution 60min after PCI ST segment deviation 60min after PCI Death, re-MI, stent thrombosis and urgent revascularisation until 48hrs, day 7, and day 30 Stroke Severe bleeding complications;Primary end point(s): Platelet reactivity index measured by VASP phosphorylisation ;Timepoint(s) of evaluation of this end point: 2 hours after the initiation of the therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Platelet reactivity index 2) Complete (>70%) ST segment resolution 3) TIMI 2/3 patency 4) TIMI 3 patency 5) TIMI 3 patency 6) ST resolution 7) Partial or no ST resolution 8) ST segment deviation 9) Death, re-MI, stent thrombosis, urgent revascularisation;Timepoint(s) of evaluation of this end point: 1) 4 hours after the initiation of the therapy 2) 60 minutes after PCI 3) prior to PCI 4) before PCI 5) after PCI 6) immediately before angiography 7) 60 minutes after PCI 8) 60 minutes after PCI 9) 48 hours, day 7, day 30 | — |
Countries
Germany
Contacts
Public ContactProject Manager
Institut für Herzinfarktforschung
Outcome results
None listed