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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)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tenecteplase
Alteplase
Streptokinase
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Tenecteplase

    Alteplase

    Streptokinase

    Arm Description

    Single i.v. bolus followed by infusion, weight adjusted

    Single i.v. bolus followed by infusion

    I.V. infusion

    Outcomes

    Primary Outcome Measures

    Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)

    Secondary Outcome Measures

    Changes from baseline in TAT
    Changes from baseline in D-dimers
    Changes from baseline in prothrombin fragments 1+2 (F1+F2)
    Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)
    Changes from baseline in plasmin-antiplasmin complex (PAP)
    Occurrence of adverse events (AE's)
    Occurrence of major bleedings
    Occurrence of minor bleedings
    Occurrence of serious adverse events (SAE's)
    Occurrence of in-hospital complications

    Full Information

    First Posted
    July 2, 2014
    Last Updated
    July 11, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02182011
    Brief Title
    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)
    Official Title
    An Open-label, Randomised, Parallel-group Comparison to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With AMI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2000 (undefined)
    Primary Completion Date
    June 2001 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tenecteplase
    Arm Type
    Experimental
    Arm Description
    Single i.v. bolus followed by infusion, weight adjusted
    Arm Title
    Alteplase
    Arm Type
    Active Comparator
    Arm Description
    Single i.v. bolus followed by infusion
    Arm Title
    Streptokinase
    Arm Type
    Active Comparator
    Arm Description
    I.V. infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Tenecteplase
    Intervention Type
    Drug
    Intervention Name(s)
    Alteplase
    Intervention Type
    Drug
    Intervention Name(s)
    Streptokinase
    Primary Outcome Measure Information:
    Title
    Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
    Time Frame
    Baseline, 2 hours after start of treatment
    Secondary Outcome Measure Information:
    Title
    Changes from baseline in TAT
    Time Frame
    Baseline, 6 and 24 hours after start of treatment
    Title
    Changes from baseline in D-dimers
    Time Frame
    Baseline, 2, 6 and 24 hours after start of treatment
    Title
    Changes from baseline in prothrombin fragments 1+2 (F1+F2)
    Time Frame
    Baseline, 2, 6 and 24 hours after start of treatment
    Title
    Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)
    Time Frame
    Baseline, 2, 6 and 24 hours after start of treatment
    Title
    Changes from baseline in plasmin-antiplasmin complex (PAP)
    Time Frame
    Baseline, 2, 6 and 24 hours after start of treatment
    Title
    Occurrence of adverse events (AE's)
    Time Frame
    Up to 30 days
    Title
    Occurrence of major bleedings
    Time Frame
    Up to 30 days
    Title
    Occurrence of minor bleedings
    Time Frame
    Up to 30 days
    Title
    Occurrence of serious adverse events (SAE's)
    Time Frame
    Up to 30 days
    Title
    Occurrence of in-hospital complications
    Time Frame
    Start of treatment until discharge from hospital

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.5_U02-1039.pdf
    Description
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    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)

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