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NCT02206646 Clinical Trial

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

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02206646
Other study ID # 1123.25
Secondary ID
Status Completed
Phase N/A
First received July 31, 2014
Last updated July 31, 2014
Start date February 2003

Study information
Verified date July 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 987
Est. completion date
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Metalyse

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary 30-day mortality after the Metalyse® Injection 30 days No
Primary Outcome assessment - 'Improvement' or 'Failure' 'Improvement' was defined as survival on 30 days and 'Failure' as death on 30 days after the Metalyse treatment. 30 days No
Primary Number of patients with adverse events up to 30 days No
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