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
About this trial
This is an interventional treatment trial for Myocardial Infarction
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
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
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
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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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