Status:
COMPLETED
Which Therapy for Acute Heart Attacks? (The WEST Study)
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Hoffmann-La Roche
Sanofi
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
In the setting of acute myocardial infarction (heart attacks), the principle objective of the WEST Study is to compare the impact on clinical outcomes of 3 different treatment strategies. The first is...
Detailed Description
The principal objective of WEST is to compare the impact on clinical outcomes of the following three treatment groups defined as Group A: optimal pharmacologic therapy (prompt administration of tenect...
Eligibility Criteria
Inclusion
- Male or non-pregnant female patients aged \>18 years
- Patients with symptoms presumed secondary to STEMI lasting at least 20 minutes and accompanied by ECG evidence \>2 mm of ST elevation in 2 or more contiguous precordial leads or in 2 or more limb leads;or \> 1mm ST elevation in 2 or more limb leads coupled with \>1 mm ST depression in 2 or more contiguous precordial leads such that the total ST deviation is \>4 mm; or presumed new left bundle branch block
- Earliest point of care and randomisation must be within 6 hours of onset of symptoms as defined in previous criteria
- Females of child-bearing age, not using a generally accepted method of contraception must have a negative urine pregnancy test
- Written informed consent prior to randomisation of study
Exclusion
- PCI expected to commence within \< 60 minutes from identification of suitable candidate
- Inability to have angiography/PCI within 3 hrs from randomisation
- Active bleeding or known hemorrhagic diathesis
- Any history of stroke, transient ischemic attack, dementia or structural CNS damage e.g. neoplasm, aneurysm, AV malformation
- Major surgery or trauma within the past 3 months
- Previous Coronary Artery Bypass Graft (CABG)
- Use of abciximab (ReoPro) or other GP IIb/IIIa antagonists within the preceding 7 days
- Any minor head trauma and/or any other trauma occurring after onset of the current myocardial infarction
- Significant hypertension (i.e. SBP \> 180 mm HG and/or DBP \> 110mm HG) at any time from presentation (earliest point of care) to randomisation
- Current treatment with vitamin K antagonist (warfarin) resulting with an INR \> 1.5
- Anticipated difficulty obtaining vascular access
- Prolonged (\>10 min) cardiopulmonary resuscitation or cardiogenic shock
- Patients who have participated in an investigational drug study within 7 days prior to randomisation
- Known renal insufficiency (prior creatinine \>2.5 mg% for men and \>2.0 mg% for women)
- Treatment with standard unfractionated heparin (heparin sodium) \>5000 IU or a therapeutic dose of any low molecular weight heparin, within 6 hours prior to randomisation
- Known thrombocytopenia (prior platelet count below 100 000/ul)
- Known sensitivity to TNKase, clopidogrel, heparin, low molecular weight heparin or abciximab
- Pregnancy or lactation, parturition within the previous 30 days
- Any serious concomitant systemic or life limiting disorder that would be incompatible with the trial
- Inability to follow protocol and comply with follow-up requirements
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00121446
Start Date
July 1 2003
Last Update
May 19 2017
Active Locations (16)
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1
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
2
Misericordia Hospital
Edmonton, Alberta, Canada
3
Royal Alexandra Hospital
Edmonton, Alberta, Canada
4
University of Alberta Hospital
Edmonton, Alberta, Canada