Erythropoietin and ischaemic heart disease. - EPO and IHD

• Conditions: 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: 6.1Level: PTClassification code 10000891

• Registration Number: EUCTR2005-004853-86-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 123

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified