A Trial on Efficacy and Safety of Full Dose Tenecteplase Combined With Unfractionated Heparin (UFH) or Enoxaparin in Acute Myocardial Infarction (AMI) in the Prehospital Setting (ASSENT 3 Plus)

This is an interventional treatment trial for Myocardial Infarction Read More

Inclusion Criteria:

• Onset of symptoms of AMI within six hours prior to randomisation
• A 12-lead ECG 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 (BP) > 180/110 mmHg (systolic blood pressure (SBP) 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg) on repeated measurements during current admission prior to randomisation
• Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding seven days
• Major surgery, biopsy of a parenchymal organ, or significant trauma within two months
• Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction (MI)
• Any known history of stroke or transient ischaemic attack or dementia
• Any known structural damage of the central nervous system
• Prolonged cardiopulmonary resuscitation (> 10 min) in the previous two weeks
• Current oral anticoagulation
• Standard UFH (heparin sodium) > 5000 international units (IU), or a subcutaneous (SC) therapeutic dose of any low molecular weight heparin (LMWH) within six hours of randomisation
• Known thrombocytopenia (prior platelet count below 100 000 cells/μL (100 x 10**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 had to 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 seven days
• Previous enrolment in this study
• Known sensitivity to tenecteplase, tissue plasminogen activator (tPA), abciximab, heparin or LMWH
• Any other condition that the investigator felt would place the patient at increased risk if the investigational therapy was initiated (e.g. known haemorrhagic diathesis, acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, severe hepatic dysfunction, diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions, active peptic ulceration, arterial aneurysm and known arterial/venous malformation, neoplasm with increased bleeding risk)
• Inability to follow protocol and comply with follow-up requirements