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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tenecteplase; Tissue Plasminogen Activator

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.