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

May 18, 2017 updated by: University of Alberta

Which Early ST Elevation Myocardial Infarction Therapy? The WEST Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada
        • Grey Nuns Community Hospital
      • Edmonton, Alberta, Canada
        • Misericordia Hospital
      • Leduc, Alberta, Canada
        • Leduc General Hospital
      • St. Albert, Alberta, Canada
        • Sturgeon Community Health Care Centre
    • British Columbia
      • Richmond, British Columbia, Canada
        • Richmond Hospital
      • Surrey, British Columbia, Canada
        • Surrey Memorial Hospital
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada
        • St. Paul'S Hospital
      • Vancouver, British Columbia, Canada
        • Lions Gate Hospital
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada
        • Dartmouth General Hospital
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth II Hospital
      • Lower Sackville, Nova Scotia, Canada
        • Cobequid Community Health Centre Emergency Department
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Heart Institute
      • Repentigny, Quebec, Canada
        • Pierre Le Gardeur Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Eli Lilly and Company
Sanofi
Hoffmann-La Roche

Investigators

  • Study Chair: Paul W. Armstrong, M.D., Canadian VIGOUR Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Registration Dates

First Submitted

July 13, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVC1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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