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

July 31, 2014 updated by: Boehringer Ingelheim

Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® (Tenecteplase) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with acute myocardial infarction

Description

Inclusion Criteria:

  • none

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metalyse
weight-adjusted dose
Drug: Metalyse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: up to 30 days
up to 30 days
30-day mortality after the Metalyse® Injection
Time Frame: 30 days
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 31, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1123.25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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