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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00148460
First received: September 7, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 3

Study Type: Interventional
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 of Tenecteplase (Metalyse®) With Accelerated Infusion of Alteplase in Asian Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Safety
  • The effects of TNK-tPA on coagulation and fibrinogenolysis (at selected clinical sites)

Estimated Enrollment: 270
Study Start Date: March 2001
Estimated Study Completion Date: February 2006
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 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >= 18 and <= 75 years.
  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:

  1. Previous coronary artery bypass grafting (CABG) surgery.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148460

Locations
China
Beijing An Zhen Hospital
Beijing, China, 100029
Beijing Friendship Hospital
Beijing, China, 100050
Beijing University
Beijing, China, 100044
Beijing Xuan Wu Hospital
Beijing, China, 100050
Bejing Tongren Hospital
Beijing, China, 100730
Center Hospital of Dalian
Dalian, China, 116033
Center Hospital of Jinan
Jinan, China, 250013
Fudan University
Shanghai, China, 200032
People's Hospital of Liaoning Province
Shenyang, China, 110015
Hong Kong
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 Joongang Hospital
Seoul, Korea, Republic of, 138736
Seoul National University Hospital
Seoul, Korea, Republic of, 100744
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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00148460     History of Changes
Other Study ID Numbers: 1123.8
Study First Received: September 7, 2005
Last Updated: October 28, 2013
Health Authority: China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Hong Kong: Department of Health

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Tenecteplase
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014