Clinical trial NCT02181985: 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)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 5989
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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)
timeFrame: Up to 30 days after discharge from hospital
measure: Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia
timeFrame: Up to 30 days after discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
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