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
NCT ID: NCT00148460
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2001-03-31
2006-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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TNK-tPA
rt-PA
Eligibility Criteria
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Inclusion Criteria
2. Asian origin.
3. Ischemic discomfort \>= 30 minutes in duration.
4. Onset of acute myocardial infarction (AMI) symptoms within 6 hours prior to randomization.
5. 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.
6. Ability to give informed consent.
Exclusion Criteria
2. Cardiogenic shock (e.g. systolic blood pressure \[SBP\] \< 90 mmHg).
3. Systolic blood pressure (SBP) \>= 180 mmHg and/or diastolic blood pressure (DBP) \>= 110 mmHg during current admission on one reliable measurement prior to randomization.
4. Inability to undergo cardiac catheterization.
5. Significant bleeding disorder either at present or within the past 6 months.
6. Major surgery, biopsy of a parenchymal organ, or significant trauma within 3 months.
7. Any minor head trauma and/or any other trauma that occurred after onset of current myocardial infarction.
8. Use of heparin, GPIIb/IIIa antagonists or other anticoagulants within the last 2 weeks.
9. Any known history of stroke or transient ischemic attack or central nervous system structural damage (i.e. neoplasm, aneurysm, intracranial surgery).
10. Prolonged cardiopulmonary resuscitation (\> 10 minutes) within 2 weeks.
11. 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).
12. Previous treatment with TNK-tPA (tenecteplase).
13. Inability to follow protocol and comply with follow-up.
14. Drug abuse within the last year.
15. Participation in another clinical trial within the previous 30 days.
18 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim Shanghai
Locations
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Beijing An Zhen Hospital
Beijing, , China
Beijing University
Beijing, , China
Beijing Friendship Hospital
Beijing, , China
Beijing Xuan Wu Hospital
Beijing, , China
Bejing Tongren Hospital
Beijing, , China
Center Hospital of Dalian
Dalian, , China
Center Hospital of Jinan
Jinan, , China
Fudan University
Shanghai, , China
People's Hospital of Liaoning Province
Shenyang, , China
The University of Hong Kong, Cardiology Division
Hong Kong, , Hong Kong
Dongsan Medical Center
Jung-Ku, , South Korea
Chunnam University Hospital
Kwangju, , South Korea
Dong-A University Hospital
Pusan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Severance Hospital
Seoul, , South Korea
Seoul Joongang Hospital
Seoul, , South Korea
A-Jou University Hospital
Suwon, , South Korea
Wonju Christian Hospital (Yonsei University Hosp)
Wŏnju, , South Korea
Countries
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Other Identifiers
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1123.8
Identifier Type: -
Identifier Source: org_study_id