Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148460
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2005-09-07
Brief Title:
Trial to Compare the Efficacy and Safety of a Single Bolus of TNK-tPA Tenecteplase Metalyse With Accelerated Infusion of Rt-PA Alteplase Actilyse in Asian Patients With Acute Myocardial Infarction
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Open-label Multi-center Angiographic Trial to Compare the Efficacy and Safety of Single Bolus of Tenecteplase Metalyse With Accelerated Infusion of Alteplase in Asian Patients With Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this trial was to compare the efficacy and safety of a single bolus of TNK-tPA tenecteplase Metalyse compared with rt-PA alteplase Actilyse in Asian patients
Detailed Description:
This was a randomized 11 open-label multi-center active-control parallel-group study to compare the efficacy and safety of TNK-tPA tenecteplase Metalyse with that of accelerated rt-PA alteplase Actilyse in Asian patients with AMI The primary endpoint TIMI 3 Flow and the secondary endpoint TIMI frame count were evaluated in a blinded manner in the core laboratory
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups ie TNK-tPA or accelerated rt-PA
The study period totaled 30-37 days and included baseline randomisation study drug administration in-hospital follow-up and thirty-day follow-up
Coronary angiography was performed at 90 minutes after the start of study drug administration 12-lead electrocardiograms ECGs were obtained before randomization between 60 to 75 minutes and 180 15 minutes after the start of study drug administration and at hospital discharge
If the patient showed rapid and progressive hemodynamic deterioration before 90 minutes rescue PTCA or other appropriate interventions should be performed at the discretion of the treating physician
Following the analysis of TIMI flow and frame count at each study center the results were carefully recorded on the CRFs This data was stored on a compact disk or a film and labeled with the subjects study ID number It was then sent with the summary worksheets and ECGs to the Angiographic Core Laboratory located at the Leuven Coordinating Center LCC of the University Hospital Gasthuisberg Leuven Belgium for central evaluations
Study Hypothesis
The null hypothesis tested was that there was no difference between the two treatment groups TNK-tPA Tenecteplase Metalyse and accelerated rt-PA Actilyse against the alternative that there was a difference
Comparisons
The primary endpoint of the study was TIMI 3 flow at 90 minutes after start of thrombolytic therapy angiograms were evaluated in a blinded manner in a core laboratory
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups ie TNK-tPA or accelerated rt-PA
The study period totaled 30-37 days and included baseline randomisation study drug administration in-hospital follow-up and thirty-day follow-up
Coronary angiography was performed at 90 minutes after the start of study drug administration 12-lead electrocardiograms ECGs were obtained before randomization between 60 to 75 minutes and 180 15 minutes after the start of study drug administration and at hospital discharge
If the patient showed rapid and progressive hemodynamic deterioration before 90 minutes rescue PTCA or other appropriate interventions should be performed at the discretion of the treating physician
Following the analysis of TIMI flow and frame count at each study center the results were carefully recorded on the CRFs This data was stored on a compact disk or a film and labeled with the subjects study ID number It was then sent with the summary worksheets and ECGs to the Angiographic Core Laboratory located at the Leuven Coordinating Center LCC of the University Hospital Gasthuisberg Leuven Belgium for central evaluations
Study Hypothesis
The null hypothesis tested was that there was no difference between the two treatment groups TNK-tPA Tenecteplase Metalyse and accelerated rt-PA Actilyse against the alternative that there was a difference
Comparisons
The primary endpoint of the study was TIMI 3 flow at 90 minutes after start of thrombolytic therapy angiograms were evaluated in a blinded manner in a core laboratory
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None