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
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria: Age >= 18 and <= 75 years. Asian origin. Ischemic discomfort >= 30 minutes in duration. Onset of acute myocardial infarction (AMI) symptoms within 6 hours prior to randomization. A twelve lead electrocardiogram (ECG) with one of the following: ST segment elevation >= 0.1 mV in two or more limb leads; or >= 0.2 mV in two or more contiguous precordial leads indicative of AMI. Ability to give informed consent. Exclusion Criteria: Previous coronary artery bypass grafting (CABG) surgery. Cardiogenic shock (e.g. systolic blood pressure [SBP] < 90 mmHg). Systolic blood pressure (SBP) >= 180 mmHg and/or diastolic blood pressure (DBP) >= 110 mmHg during current admission on one reliable measurement prior to randomization. Inability to undergo cardiac catheterization. Significant bleeding disorder either at present or within the past 6 months. Major surgery, biopsy of a parenchymal organ, or significant trauma within 3 months. Any minor head trauma and/or any other trauma that occurred after onset of current myocardial infarction. Use of heparin, GPIIb/IIIa antagonists or other anticoagulants within the last 2 weeks. Any known history of stroke or transient ischemic attack or central nervous system structural damage (i.e. neoplasm, aneurysm, intracranial surgery). Prolonged cardiopulmonary resuscitation (> 10 minutes) within 2 weeks. Pregnancy, lactation or parturition within the previous 30 days. Women of childbearing potential must have had a negative pregnancy test and must have used a medically accepted method of birth control (i.e. uterine device, surgical sterilisation, progestogens alone). Previous treatment with TNK-tPA (tenecteplase). Inability to follow protocol and comply with follow-up. Drug abuse within the last year. Participation in another clinical trial within the previous 30 days.
Sites / Locations
- Beijing An Zhen Hospital
- Beijing University
- Beijing Friendship Hospital
- Beijing Xuan Wu Hospital
- Bejing Tongren Hospital
- Center Hospital of Dalian
- Center Hospital of Jinan
- Fudan University
- People's Hospital of Liaoning Province
- The University of Hong Kong, Cardiology Division
- Dongsan Medical Center
- Chunnam University Hospital
- Dong-A University Hospital
- Seoul National University Hospital
- Yonsei University Severance Hospital
- Seoul Joongang Hospital
- A-Jou University Hospital
- Wonju Christian Hospital (Yonsei University Hosp)