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

Boehringer Ingelheim

Status: Completed

Conditions: Myocardial Infarction

Treatments: Drug: Metalyse

Study type: Observational

Funder types: Industry

Identifiers

NCT02206646

1123.25

Details and patient eligibility

About

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.

Enrollment: 987 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• none

Exclusion criteria

• none

Trial design

987 participants in 1 patient group

Metalyse

Description:

weight-adjusted dose

Treatment:

Drug: Metalyse