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Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI) (ASSENT 3)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Full dose TNK-tPA
Half dose TNK-tPA
Heparin
Enoxaparin
Abciximab
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 six hours prior to randomisation
  • A twelve-lead electrocardiogram with one of the following: 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 left bundle-branch block
  • Age ≥ 18
  • Informed consent received

Exclusion Criteria:

  • Hypertension defined as blood pressure > 180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on repeated measurements during current admission prior to randomization
  • Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding 7 days
  • Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
  • Any minor head trauma and any other trauma occurring after 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
  • Prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks
  • Current oral anticoagulation
  • Standard unfractionated heparin (heparin sodium) >5000 IU or a subcutaneous dose within 6 hours of randomization of a therapeutic dose of any low molecular weight heparin
  • Known thrombocytopenia (prior platelet count below 100000 cells/μl (100 x10**9/l))
  • Known renal insufficiency (prior S-creatinine >2.5 mg% (>220 μmol/l) for men and >2.0 mg% (>175 μmol/l)) for women
  • Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control
  • Treatment with an investigational drug under another study protocol in the past 7 days
  • Previous enrollment in this study
  • Known sensitivity to TNK-tPA, tPA, abciximab, heparin or low molecular weight heparin
  • Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
  • Inability to follow protocol and comply with follow-up requirements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    TNK-tPA + heparin

    TNK-tPA + enoxaparin

    TNK-tPA + abciximab + heparin

    Arm Description

    Outcomes

    Primary Outcome Measures

    Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH)
    Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia

    Secondary Outcome Measures

    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
    NCT02181985
    Brief Title
    Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI)
    Acronym
    ASSENT 3
    Official Title
    A Phase IIIb, Randomised, Open Label Trial With 3 Parallel Groups: Full Dose TNK-tPA Together With Heparin Sodium, Full Dose TNK-tPA Together With Enoxaparin, and Half Dose TNK-tPA Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction: ASSENT 3 (Assessment of the Safety and Efficacy of New Thrombolytic Regimens)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2000 (undefined)
    Primary Completion Date
    April 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
    The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with abciximab and heparin sodium (group C).

    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
    5989 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TNK-tPA + heparin
    Arm Type
    Active Comparator
    Arm Title
    TNK-tPA + enoxaparin
    Arm Type
    Experimental
    Arm Title
    TNK-tPA + abciximab + heparin
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Full dose TNK-tPA
    Intervention Type
    Drug
    Intervention Name(s)
    Half dose TNK-tPA
    Intervention Type
    Drug
    Intervention Name(s)
    Heparin
    Intervention Type
    Drug
    Intervention Name(s)
    Enoxaparin
    Intervention Type
    Drug
    Intervention Name(s)
    Abciximab
    Primary Outcome Measure Information:
    Title
    Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH)
    Time Frame
    Up to 30 days after discharge from hospital
    Title
    Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia
    Time Frame
    Up to 30 days after 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 six hours prior to randomisation A twelve-lead electrocardiogram with one of the following: 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 left bundle-branch block Age ≥ 18 Informed consent received Exclusion Criteria: Hypertension defined as blood pressure > 180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on repeated measurements during current admission prior to randomization Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding 7 days Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months Any minor head trauma and any other trauma occurring after 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 Prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks Current oral anticoagulation Standard unfractionated heparin (heparin sodium) >5000 IU or a subcutaneous dose within 6 hours of randomization of a therapeutic dose of any low molecular weight heparin Known thrombocytopenia (prior platelet count below 100000 cells/μl (100 x10**9/l)) Known renal insufficiency (prior S-creatinine >2.5 mg% (>220 μmol/l) for men and >2.0 mg% (>175 μmol/l)) for women Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control Treatment with an investigational drug under another study protocol in the past 7 days Previous enrollment in this study Known sensitivity to TNK-tPA, tPA, abciximab, heparin or low molecular weight heparin Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated Inability to follow 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/1123/1123.10_U02.1224.pdf
    Description
    Related Info

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    Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI)

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