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

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.

Completed

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

none

Exclusion criteria

none

Treatment and study plan

Metalyse

Drug

Primary outcomes

30-day mortality after the Metalyse® Injection

Time frame: 30 days
Outcome assessment - 'Improvement' or 'Failure'

Time frame: 30 days

'Improvement' was defined as survival on 30 days and 'Failure' as death on 30 days after the Metalyse treatment.
Number of patients with adverse events

Time frame: up to 30 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2009
First posted: Aug 1, 2014
Registry last updated: Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed