Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® in Korean Patients With Acute Myocardial Infarction

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Metalyse

• Registration Number: NCT02206646
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations:

1. Unexpected adverse drug reactions

2. Frequency and nature of adverse events (AEs)

3. Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of Metalyse® was also assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2009-02
• Status Verified: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-07-31
• Last Update Submitted: 2014-07-31
• Study First Posted: 2014-08-01
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 987

Inclusion Criteria

• none

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metalyse	Metalyse	weight-adjusted dose

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 30 days
30-day mortality after the Metalyse® Injection	30 days
Outcome assessment - 'Improvement' or 'Failure'	30 days	'Improvement' was defined as survival on 30 days and 'Failure' as death on 30 days after the Metalyse treatment.