Acute ST elevation myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction
Conditions
Interventions
Trade Name: NeoRecormon
Product Name: NeoRecormon
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
R
Sponsors
Imperial College Heathcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: =18 years of age Weight between = 50 kg and =120 kg Suspected of having his/her first-documented STEMI Symptoms of ischemia of = 20 min with = 6h prior to PCI =1mm ST elevation in at least two contiguous limb leads or = 2mm ST elevation in 2 contiguous chest leads Primary PCI to occur within 6h from the onset of symptoms Women of childbearing potential must have a negative pregnancy test 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: Age = 80 History or ECG evidence of previous STEMI Cardiogenic shock NYHA class III-IV heart failure LBBB or AF on electrocardiogram Major trauma, major surgery, eye, spinal cord, or brain surgery within the last 3 months History of advanced liver disease History of chronic renal impairment (creatinine >200µmol/L) History of stroke Pregnancy or breast-feeding Dependence on alcohol or other drugs of abuse Significant psychiatric/neurological disease that might prevent adherence to the requirements of the protocol Current treatment with human recombinant erythropoietin Current haemodialysis or peritoneal dialysis History of malignancy including haematological and other solid tissue tumours History of primary or secondary polycythaemia Inability to read the patient information sheet History of pulmonary embolism or deep vein thrombosis History of critical limb ischaemia Patients with poorly controlled hypertension (systolic BP>180, diastolic BP>100mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of erythropoietin to reduce myocardial infarct size as a proportion of area at risk in patients with acute ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention within 6h of symptom onset;Secondary Objective: To evaluate the efficacy of erythropoietin to improve measures of global and regional remodelling and contractile function in patients with acute ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention within 6h of symptom onset;Primary end point(s): Difference in regional end-systolic wall thickness in the distribution territory of the culprit artery subjects treated with placebo and erythropoietin at 180 days. Change in myocardial infarct size as a proportion of area at risk between the day 3-5 cardiovascular MR scan and the day 180 cardiovascular MR scan in subjects treated with placebo and erythropoietin. | — |
Countries
United Kingdom
Outcome results
None listed