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
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised, Open-Label, Multi-Center, Angiographic Trial to Compare the Efficacy and Safety of Single Bolus TNK-tPA (Tenecteplase, Metalyse) With Accelerated Infusion of rt-PA (Alteplase, Actilyse) in Asian Patients With Acute Myocardial Infarction|
- The percentage of patients with thrombolysis in myocardial infarction (TIMI) grade 3 flow in the infarct-related artery (IRA) [ Time Frame: at 90 minutes after the start of thrombolytic treatment ]
- Infarct-related artery patency [ Time Frame: at 90 minutes ]
- The percentage of subjects with ST-segment resolution [ Time Frame: at 60 and 180 minutes ]
- Mortality [ Time Frame: 30-days ]
- The effects of TNK-tPA on coagulation and fibrinogenolysis (at selected clinical sites)
|Study Start Date:||March 2001|
|Estimated Study Completion Date:||February 2006|
This was a randomized (1:1), 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 (i.e. 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 subject's study I.D. 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.
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.
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.
|Beijing, China, 100044|
|Beijing Xuan Wu Hospital|
|Beijing, China, 100050|
|Beijing Friendship Hospital|
|Beijing, China, 100050|
|Beijing An Zhen Hospital|
|Beijing, China, 100029|
|Bejing Tongren Hospital|
|Beijing, China, 100730|
|Center Hospital of Dalian|
|Dalian, China, 116033|
|Center Hospital of Jinan|
|Jinan, China, 250013|
|Shanghai, China, 200032|
|People's Hospital of Liaoning Province|
|Shenyang, China, 110015|
|The University of Hong Kong, Cardiology Division|
|Hong Kong, Hong Kong|
|Korea, Republic of|
|Dongsan Medical Center|
|Jung-Ku, Korea, Republic of, 700711|
|Chunnam University Hospital|
|Kwang-Ju, Korea, Republic of, 501757|
|Dong-A University Hospital|
|Pusan, Korea, Republic of, 602715|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 100744|
|Seoul Joongang Hospital|
|Seoul, Korea, Republic of, 138736|
|Yonsei University Severance Hospital|
|Seoul, Korea, Republic of, 120752|
|A-Jou University Hospital|
|Suwon, Korea, Republic of, 443721|
|Wonju Christian Hospital (Yonsei University Hosp)|
|Wonju, Korea, Republic of|
|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Shanghai|