Status:
COMPLETED
The STREAM Percutaneous Coronary Intervention Anticoagulant Sub-study
Lead Sponsor:
Robert Welsh
Collaborating Sponsors:
Sanofi
Boehringer Ingelheim
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and efficacy of Enoxaparin and Unfractionated Heparin in St Elevation Myocardial Infarction patients undergoing primary percutaneous coronary interven...
Detailed Description
Past research in stable patients with coronary artery disease and those with non-ST elevation acute coronary syndromes (NSTEMI) has demonstrated the safety and efficacy of enoxaparin as an anticoagula...
Eligibility Criteria
Inclusion
- 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 acute STEMI: \>2 mm ST elevation across 2 contiguous precordial leads (best 2 of V1-V6) or leads I, AVL for a minimum combined total of \>4 mm ST elevation,or \>3 mm ST elevation in 2 contiguous inferior leads (best 2 of II, III, AVF) for a minimum combined total of \> 6 mm ST elevation.
- Informed consent received
Exclusion
- PCI (1st balloon inflation) expected to commence \< 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the cardiac catheterization laboratory (1st balloon 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 within the 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 or clinical diagnosis associated with increased risk of bleeding including: known active peptic ulceration and/or neoplasm with increased bleeding risk.
- Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (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 \<3 months)
- 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 2 weeks
- Known acute pericarditis and/or subacute bacterial endocarditis
- Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, 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 of childbearing potential must be using a medically accepted method of birth control
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days
- Known hypersensitivity to tenecteplase, alteplase, ASA, clopidogrel, enoxaparin, or to any of the excipients or to the contrast media used in angiography Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00882635
Start Date
October 1 2008
End Date
June 1 2012
Last Update
July 2 2012
Active Locations (2)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
Southlake
Newmarket, Ontario, Canada, l3y 2P9