Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 (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 (alte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00148460
Start Date
March 1 2001
End Date
February 1 2006
Last Update
October 29 2013
Active Locations (18)
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1
Beijing An Zhen Hospital
Beijing, China, 100029
2
Beijing University
Beijing, China, 100044
3
Beijing Friendship Hospital
Beijing, China, 100050
4
Beijing Xuan Wu Hospital
Beijing, China, 100050