Acute myocardial infarction MedDRA version: 12.0 Level: LLT Classification code 10000891 Term: Acute myocardial infarction
Conditions
Interventions
Trade Name: Efient
Product Name: Prasugrel
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PRASUGREL
CAS Number: 150322-43-3
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Deutsches Herzzentrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients presenting within 24 hours from the onset of symptoms, with chest pain lasting = 20 minutes and with = 0.1 mV of ST-segment elevation in = 2 adjacent limb leads or = 0.2 mV in = 2 contiguous precordial leads or new left bundle branch block on surface ECG 2. Informed, written consent 3. In women with childbearing potential a pregnancy test is obligatory. 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 ;Inclusion criteria: 1. Patients presenting within 24 hours from the onset of symptoms, with chest pain lasting = 20 minutes and with = 0.1 mV of ST-segment elevation in = 2 adjacent limb leads or = 0.2 mV in = 2 contiguous precordial leads or new left bundle branch block on surface ECG 2. Informed, written consent 3. In women with childbearing potential a pregnancy test is obligatory. 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. Age < 18 years 2. Cardiogenic shock or prolonged cardio-pulmonary resuscitation 3. Active bleeding; bleeding diathesis; coagulopathy 4. History of gastrointestinal or genitourinary bleeding within the previous 2 months 5. Refusal to receive blood transfusion 6. Major surgery in the last 6 weeks 7. History of intracranial bleeding or structural abnormalities (intracerebral mass, aneurysm, arteriovenous malformation) 8. Suspected aortic dissection; 9. TIA within the last two weeks 10. Heparin-induced thrombocytopenia 11. Any previous stroke 12. Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI 13. Known relevant hematological deviations: hemoglobin < 100 g/l platelet count < 100 x 109 cells/l 14. Use of coumadin derivatives within the last 7 days 15. Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), cyclooxygenase-2 inhibitors, prasugrel. 16. Known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance 17. Known severe liver disease 18. Known severe renal failure with GFR <30 ml/min and/or dialysis 19. Known allergy to the study medications 20. Previous enrollment in this trial 21. Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding. 22. Patient’s inability to fully cooperate with the study protocol ;Exclusion criteria: 1. Age < 18 years 2. Cardiogenic shock or prolonged cardio-pulmonary resuscitation 3. Active bleeding; bleeding diathesis; coagulopathy 4. History of gastrointestinal or genitourinary bleeding within the previous 2 months 5. Refusal to receive blood transfusion 6. Major surgery in the last 6 weeks 7. History of intracranial bleeding or structural abnormalities (intracerebral mass, aneurysm, arteriovenous malformation) 8. Suspected aortic dissection; 9. TIA within the last two weeks 10. Heparin-induced thrombocytopenia 11. Any previous stroke 12. Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI 13. Known relevant hematological deviations: hemoglobin < 100 g/l platelet count < 100 x 109 cells/l 14. Use of coumadin derivatives within the last 7 days 15. Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), cyclooxygenase-2 inhibitors, prasugrel. 16. Known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance 17. Known severe liver disease 18. Known severe renal failure with GFR <30 ml/min and/or dialysis 19. Known allergy to the study medications 20. Previous enrollment in this trial 21. Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding. 22. Patient’s inability to fully cooperate with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The hypothesis to be tested is that in STEMI patients undergoing PPCI, a strategy based on 60 mg prasugrel pretreatment plus bivalirudin is superior to a strategy of 600 mg clopidogrel pretreatment plus heparin in terms of clinical outcomes (composite of all-cause death, recurrent myocardial infarction, urgent infarct-related artery revascularization, stroke, definite stent thrombosis or major bleeding; superiority hypothesis).;Secondary Objective: The secondary endpoints are the following: Composite of all-cause death, recurrent myocardial infarction, unplanned IRA revascularization, stroke or definite stent thrombosis at 30 days after randomization (ischemic end point) Incidence of major bleeding according to HORIZONS-AMI definitions at 30 days after randomization Bleeding events will also be assessed according to the TIMI criteria Cardiac death rate at 30 days after randomization;Primary end point(s): A composite of all-cause death, recurrent myocardial infarction, unplanned IRA revascularization, stroke, definite stent thrombosis (according to Academic Research Consortium definition) or major bleeding (according to HORIZONS-AMI trial definition) at 30 days after randomization. ;Main Objective: The hypothesis to be tested is that in STEMI patients undergoing PPCI, a strategy based on 60 mg prasugrel pretreatment plus bivalirudin is superior to a strategy of 600 mg clopidogrel pretreatment plus heparin in terms of clinical outcomes (composite of all-cause death, recurrent myocardial infarction, urgent infarct-related artery revascularization, stroke, definite stent thrombosis or major bleeding; superiority hypothesis).;Secondary Objective: The secondary endpoints are the following: Composite of all-cause death, recurrent myocardial infarction, unplanned IRA revascularization, stroke or definite stent thrombosis at 30 days after randomization (ischemic end point) Incidence of major bleeding according to HORIZONS-AMI definitions at 30 days afte | — |
Countries
Germany
Contacts
Public Contact; ;
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Outcome results
None listed