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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02206646

Enrollment

987

Registered

2014-08-01

Start date

2003-02-28

Completion date

Unknown

Last updated

2014-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

Interventions

DRUGMetalyse

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* none

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
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.
Number of patients with adverse events	up to 30 days	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026