The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882466
• Other study ID #: EPO in AMI
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2009
• Last updated: April 16, 2009
• Start date: May 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute myocardial infarction <12hr

• Age >18yrs

• First myocardial infarction

• culprit lesion : proximal to mid left anterior descending artery

• Baseline coronary flow : TIMI Grade 0~1

Exclusion Criteria:

• Patients with previous myocardial infarction

• History of thrombotic complication

• History of cerebral infarction

• Uncontrolled hypertension

• Increased hemoglobin level >17g/dL

• Patients with mechanical valve

• Cardiogenic shock

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• human recombinant erythropoietin
intravenous bolus injection of EPO (50unit/kg)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine kinase (CK), creatinine kinase-MB (CK-MB)		4hr, 8hr, 12hr, 24hr, 48hr, 72hr	No
Secondary	Infarct size assessed by cardiac MRI		day 4	No