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)

Last updated: July 11, 2014
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

3

Condition

Cardiac Disease

Myocardial Ischemia

Blood Clots

Treatment

N/A

Clinical Study ID

NCT02182011
1123.5
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 leadsindicative of AMI, or new left bundle-branch block

  • Age ≥ 18

Exclusion

Exclusion Criteria:

  • Hypertension defined as blood pressure > 180/110 mmHg (systolic BP > 180 mmHg and/ordiastolic BP > 110 mmHg) on repeated measurements during current admission prior torandomisation

  • 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 currentmyocardial 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 childbearingpotential must have a negative pregnancy test

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

  • Previous enrolment in this study

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

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

Study Design

Total Participants: 49
Study Start date:
May 01, 2000
Estimated Completion Date: