NCT02206646

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. 1.Unexpected adverse drug reactions
  2. 2.Frequency and nature of adverse events (AEs)
  3. 3.Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of Metalyse® was also assessed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
987

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

6 years

First QC Date

July 31, 2014

Last Update Submit

July 31, 2014

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

  • 30-day mortality after the Metalyse® Injection

    30 days

  • 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

  • Number of patients with adverse events

    up to 30 days

Study Arms (1)

Metalyse

weight-adjusted dose

Drug: Metalyse

Interventions

MetalyseDRUG
Metalyse

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with acute myocardial infarction

You may qualify if:

  • none

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Tissue Plasminogen ActivatorSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 1, 2014

Study Start

February 1, 2003

Primary Completion

February 1, 2009

Last Updated

August 1, 2014

Record last verified: 2014-07