A phase 2 randomised trial to investigate the effects of recombinant human erythropoietin on infarct size in patients undergoing primary percutaneous coronary angiography for ST-segment elevation myocardial infarction. - Erythropoietin in acute MI

• Conditions: Acute ST elevation myocardial infarction; MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction

• Registration Number: EUCTR2004-005259-32-GB
• Lead Sponsor: Imperial College Heathcare NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-07
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br><br>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.<br>