Post Marketing Surveillance to Monitor the Safety and Eff... | NCT02206646

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

NCT02206646

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Aug 1, 2014Estimated

Enrollment

987Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

Metalyse

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Feb 2009Actual

Completion Date

Not provided

First Submitted Date

Jul 31, 2014

First Submission Date that Met QC Criteria

Jul 31, 2014

First Posted Date

Aug 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2014

Last Update Posted Date

Aug 1, 2014Estimated

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

987Actual

Label	Type	Description	Intervention Names
Metalyse		weight-adjusted dose	Drug: Metalyse

Name	Type	Description	Arm Group Labels	Other Names
Metalyse	Drug		Metalyse

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

none

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients diagnosed with acute myocardial infarction

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077785	Tenecteplase

Ancestor Terms

ID	Term
D010959	Tissue Plasminogen Activator
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided