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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00148460 |
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.
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction |
Drug: TNK-tPA Drug: rt-PA |
Phase III |
Study Type: | Interventional |
Study Design: | Active Control, Open Label, Parallel Assignment, Randomized, Safety/Efficacy Study, 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 |
Estimated Enrollment: | 240 |
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.
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.
Comparison(s):
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A twelve lead electrocardiogram (ECG) with one of the following:
Exclusion Criteria:
China | |
Beijing University | |
Beijing, China, 100044 | |
Beijing Xuan Wu Hospital | |
Beijing, China, 100050 | |
Beijing Friendship Hospital | |
Beijing, China, 100050 | |
Beijing An Zhen Hospital | |
Beijing, China, 100029 | |
Center Hospital of Jinan | |
Jinan, China, 250013 | |
People's Hospital of Liaoning Province | |
Shenyang, China, 110015 | |
Center Hospital of Dalian | |
Dalian, China, 116033 | |
Fudan University | |
Shanghai, China, 200032 | |
Bejing Tongren Hospital | |
Beijing, China, 100730 | |
Hong Kong | |
The University of Hong Kong, Cardiology Division | |
Hong Kong, Hong Kong | |
Korea, Republic of | |
Wonju Christian Hospital (Yonsei University Hosp) | |
Wonju, Korea, Republic of | |
Chunnam University Hospital | |
Kwang-Ju, Korea, Republic of, 501757 | |
Dongsan Medical Center | |
Jung-Ku, Korea, Republic of, 700711 | |
Dong-A University Hospital | |
Pusan, Korea, Republic of, 602715 | |
Yonsei University Severance Hospital | |
Seoul, Korea, Republic of, 120752 | |
Seoul Joongang Hospital | |
Seoul, Korea, Republic of, 138736 | |
A-Jou University Hospital | |
Suwon, Korea, Republic of, 443721 | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 100744 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai |
Study ID Numbers: | 1123.8 |
Study First Received: | September 7, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00148460 History of Changes |
Health Authority: | China: State Food and Drug Administration; Hong Kong: Department of Health; South Korea: Korea Food and Drug Administration (KFDA) |
Fibrin Modulating Agents Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases Tissue Plasminogen Activator |
Tenecteplase Fibrinolytic Agents Cardiovascular Agents Ischemia Infarction Myocardial Infarction |
Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Hematologic Agents Vascular Diseases Tenecteplase Fibrinolytic Agents Cardiovascular Agents Ischemia |
Pharmacologic Actions Necrosis Fibrin Modulating Agents Pathologic Processes Therapeutic Uses Cardiovascular Diseases Infarction Myocardial Infarction |