a Patients with ST-segment elevation AMI treated within 6 hours of symptom-onset. b Patients with chronic stable angina refractory to medical therapy who are not candidates for surgical or percutaneous coronary revascularisation. MedDRA version: 6.1 Level: PT Classification code 10000891
Conditions
Interventions
Trade Name: EPREX IV SC 1FL 1ML 10000 UI
Pharmaceutical Form: Solution for injection
CAS Number: 113427-24-0
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients with AMI - continuous chest pain lasting 30 minutes but 6 hours; - 1mm ST-segment elevation on 2 ECG leads or new left bundle branch block; - planned treatment by primary percutaneous coronary angioplasty; - age 75 years; - signed informed consent. Inclusion criteria for patients with CSA - significant coronary artery disease at angiography; - maximal drug therapy; - inducible ischaemia on exercise testing; - no indication to undergo percutaneous or surgical coronary revascularisation; - age 75 years; - signed 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: Exclusion criteria for patients with AMI - previous myocardial infarction; - previous thrombolysis or treatment with EPO; - previous cerebrovascular event; - uncontrolled hypertension; - hematocrit 48 in men and 45 in women; - haemoglobin 16 g/dl in men and 15 g/dl in women; - major surgery, major trauma or blood transfusions in the previous 6 weeks; - current oral anticoagulant therapy; - allergy to aspirin; - renal, lung or liver failure; - myeloproliferative diseases or malignancies; - possible or known pregnancy; - participation in other clinical randomised trial; - pacemaker in situ. Exclusion criteria for patients with CSA - previous treatment with EPO; - previous cerebrovascular event; - uncontrolled hypertension; - hematocrit 48 in men and 45 in women; - haemoglobin 16 g/dl in men and 15 g/dl in women; - major surgery, major trauma or blood transfusions in the previous 6 weeks; - current oral anticoagulant therapy; - allergy to aspirin; - renal, lung or liver failure; - myeloproliferative diseases or malignancies; - possible or known pregnancy; - participation in other clinical randomised trial; - percutaneous or surgical coronary revascularisation in the previous 6 months; - pacemaker in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to compare the effects of erythropoietin EPO versus placebo on myocardial function and possible adverse drug-related events.;Secondary Objective: The secondary aim of the study is to compare the effects of EPO versus placebo on a left ventricular remodelling in patients with AMI, and on b myocardial perfusion in patients with chronic stable angina.;Primary end point(s): To assess differences in infarct size for patients with AMI or in ischaemic threshold for patients with CSA between those randomized to receive EPO and those receiving placebo. | — |
Countries
Italy
Outcome results
None listed