A Study to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With Acute Myocardial Infarction (AMI)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values.

Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence of adverse events (AE's), in -hospital complications, major or minor bleedings and serious adverse events.

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

Details

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

Criteria

Inclusion Criteria:

• Onset of symptoms of AMI within 6 hours from randomisation

• A twelve-lead electrocardiogram (ECG) showing ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguous precordial leads indicative of AMI, or new left bundle-branch block

• Age ≥ 18

Exclusion Criteria:

• Hypertension defined as blood pressure > 180/110 mmHg (systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg) on repeated measurements during current admission prior to randomisation

• Use of abciximab (ReoPro®) within the preceding 7 days or eptifibatide (Integrilin®) or tirofiban (aggrastat®) within the past 48 hours

• Use of heparin within the preceding 12 hours

• Current therapeutic oral anticoagulation

• Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months

• Any minor head trauma and any other trauma occurring after the onset of the current myocardial infarction

• Any known history of stroke or transient ischemic attack or dementia

• Any known structural damage of the central nervous system

• Ruptured aortic aneurism

• Active bleeding

• Prolonged cardiopulmonary resuscitation (> 10 minutes) in the previous two weeks

• Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test

• Any known active participation in another investigative drug study or device protocol in the past 30 days

• Previous enrolment in this study

• Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy were initiated

• Inability to follow the protocol and comply with follow-up requirements