Phase
Condition
Coronary Artery Disease
Heart Defect
Congestive Heart Failure
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age equal or greater than 18 years
Onset of symptoms of STEMI < 3 hours prior to randomisation
12-lead ECG (ST elevation will be measured from the J point) indicative of an acuteSTEMI: >2 mm ST elevation across 2 contiguous precordial leads (best 2 of V1-V6) orleads I, AVL for a minimum combined total of >4 mm ST elevation,or >3 mm ST elevationin 2 contiguous inferior leads (best 2 of II, III, AVF) for a minimum combined totalof > 6 mm ST elevation.
Informed consent received
Exclusion
Exclusion Criteria:
PCI (1st balloon inflation) expected to commence < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the cardiac catheterization laboratory (1stballoon inflation) within 3 hours after randomisation.
Anticipated or obvious problem with vascular access.
Previous CABG
Left bundle branch block or ventricular pacing.
Patients with cardiogenic shock - Killip Class 4
Patients with a body weight < 55 kg (known or estimated)
Uncontrolled hypertension, defined as blood pressure measurement > 180/110 mm Hg (systolic BP > 180 mm Hg and/or diastolic BP > 110 mm Hg) confirmed on repeat measures (2 documented measurements at any time) prior to randomization.
Known use oral anticoagulants (warfarin or coumadin) or GP IIb/IIIa antagonists withinthe preceding 7 days or recent administration of any IV or SC anticoagulation within 12 hours including: unfractionated heparin, enoxaparin, and/or bivalirudin.
Active bleeding, known bleeding diathesis/disorder including thrombocytopenia orclinical diagnosis associated with increased risk of bleeding including: known activepeptic ulceration and/or neoplasm with increased bleeding risk.
Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2months (this includes any trauma associated with the current AMI)
Any history of central nervous system abnormality (i.e. neoplasm, aneurysm,intracranial or spinal surgery) or recent trauma to the head or cranium (i.e <3months)
Any known history of haemorrhagic stroke or stroke of unknown origin
Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months
Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2weeks
Known acute pericarditis and/or subacute bacterial endocarditis
Known acute pancreatitis or known severe hepatic dysfunction, including hepaticfailure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
Chronic dialysis or 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 or parturition within the previous 30 days; women ofchildbearing potential must be using a medically accepted method of birth control
Previous enrolment in this study or treatment with an investigational drug or deviceunder another study protocol in the past 7 days
Known hypersensitivity to tenecteplase, alteplase, ASA, clopidogrel, enoxaparin, or toany of the excipients or to the contrast media used in angiography Inability to followthe protocol and comply with follow-up requirements or any other reason that theinvestigator feels would place the patient at increased risk if the investigationaltherapy is initiated
Study Design
Study Description
Connect with a study center
University of Alberta Hospital
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Southlake
NewMarket, Ontario l3y 2P9
CanadaSite Not Available
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