Which Therapy for Acute Heart Attacks? (The WEST Study)

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Sanofi
Eli Lilly and Company
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00121446
First received: July 13, 2005
Last updated: January 19, 2006
Last verified: July 2005
  Purpose

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 using medical (drug) therapy alone with standard care. The second strategy is identical medical (drug) therapy as the first group combined with early heart catheterization (within 24 hours) for angiography and if required, intervention. The third treatment strategy is direct admission (within 3 hrs) to the heart catheterization lab for angioplasty.

WEST patients will be enrolled at first medical contact (using emergency medical services, e.g. ambulance) if possible or through Emergency Departments in participating health care facilities.


Condition Intervention Phase
Myocardial Infarction
Drug: tenecteplase
Drug: enoxaparin
Drug: clopidogrel
Procedure: percutaneous coronary intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Which Early ST Elevation Myocardial Infarction Therapy? The WEST Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • composite of 6 elements defined by: death
  • recurrent myocardial infarction
  • heart failure
  • cardiogenic shock
  • refractory ischemia
  • major ventricular arrhythmia

Secondary Outcome Measures:
  • 90 and 180 minute ECG ST resolution
  • QRS determined infarct size at discharge/day 7
  • CK infarct size determined by area under the curve or peak CK-MB

Estimated Enrollment: 300
Study Start Date: July 2003
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 tenecteplase (TNKase) and enoxaparin) at the earliest point of medical contact with usual post MI care; Group B: an identical pharmacological reperfusion strategy followed by an early invasive strategy including timely mechanical intervention, Group C: timely primary percutaneous coronary intervention (PCI), undertaken after enoxaparin and an oral loading dose of clopidogrel.

The secondary objective of WEST is to compare clinical outcomes of patients receiving optimal pharmacologic therapy and a strategy of usual post-MI care, Group A versus protocol-mandated early catheterisation and PCI, Group B.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121446

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Misericordia Hospital
Edmonton, Alberta, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Leduc General Hospital
Leduc, Alberta, Canada
Sturgeon Community Health Care Centre
St. Albert, Alberta, Canada
Canada, British Columbia
Richmond Hospital
Richmond, British Columbia, Canada
Surrey Memorial Hospital
Surrey, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Lions Gate Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Dartmouth General Hospital
Dartmouth, Nova Scotia, Canada
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Cobequid Community Health Centre Emergency Department
Lower Sackville, Nova Scotia, Canada
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Pierre Le Gardeur Hospital
Repentigny, Quebec, Canada
Sponsors and Collaborators
University of Alberta
Hoffmann-La Roche
Sanofi
Eli Lilly and Company
Investigators
Study Chair: Paul W. Armstrong, M.D. Canadian VIGOUR Centre
  More Information

Additional Information:
No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00121446     History of Changes
Other Study ID Numbers: CVC1002
Study First Received: July 13, 2005
Last Updated: January 19, 2006
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Heart Attack
ST Elevation Myocardial Infarction
fibrinolytic therapy
percutaneous coronary intervention
Acute Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Enoxaparin
Tenecteplase
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014