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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
tenecteplase
enoxaparin
clopidogrel
percutaneous coronary intervention
Sponsored by
University of Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Heart Attack, ST Elevation Myocardial Infarction, fibrinolytic therapy, percutaneous coronary intervention, Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grey Nuns Community Hospital
  • Misericordia Hospital
  • Royal Alexandra Hospital
  • University of Alberta Hospital
  • Leduc General Hospital
  • Sturgeon Community Health Care Centre
  • Richmond Hospital
  • Surrey Memorial Hospital
  • Lions Gate Hospital
  • St. Paul's Hospital
  • Vancouver General Hospital
  • Dartmouth General Hospital
  • Queen Elizabeth II Hospital
  • Cobequid Community Health Centre Emergency Department
  • Montreal Heart Institute
  • Pierre Le Gardeur Hospital

Outcomes

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

Full Information

First Posted
July 13, 2005
Last Updated
May 18, 2017
Sponsor
University of Alberta
Collaborators
Hoffmann-La Roche, Sanofi, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00121446
Brief Title
Which Therapy for Acute Heart Attacks? (The WEST Study)
Official Title
Which Early ST Elevation Myocardial Infarction Therapy? The WEST Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
Hoffmann-La Roche, Sanofi, Eli Lilly and Company

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Heart Attack, ST Elevation Myocardial Infarction, fibrinolytic therapy, percutaneous coronary intervention, Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tenecteplase
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention
Primary Outcome Measure Information:
Title
composite of 6 elements defined by: death
Title
recurrent myocardial infarction
Title
heart failure
Title
cardiogenic shock
Title
refractory ischemia
Title
major ventricular arrhythmia
Secondary Outcome Measure Information:
Title
90 and 180 minute ECG ST resolution
Title
QRS determined infarct size at discharge/day 7
Title
CK infarct size determined by area under the curve or peak CK-MB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul W. Armstrong, M.D.
Organizational Affiliation
Canadian VIGOUR Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Misericordia Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Leduc General Hospital
City
Leduc
State/Province
Alberta
Country
Canada
Facility Name
Sturgeon Community Health Care Centre
City
St. Albert
State/Province
Alberta
Country
Canada
Facility Name
Richmond Hospital
City
Richmond
State/Province
British Columbia
Country
Canada
Facility Name
Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Lions Gate Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Dartmouth General Hospital
City
Dartmouth
State/Province
Nova Scotia
Country
Canada
Facility Name
Queen Elizabeth II Hospital
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Cobequid Community Health Centre Emergency Department
City
Lower Sackville
State/Province
Nova Scotia
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Pierre Le Gardeur Hospital
City
Repentigny
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16757491
Citation
Armstrong PW; WEST Steering Committee. A comparison of pharmacologic therapy with/without timely coronary intervention vs. primary percutaneous intervention early after ST-elevation myocardial infarction: the WEST (Which Early ST-elevation myocardial infarction Therapy) study. Eur Heart J. 2006 Jul;27(13):1530-8. doi: 10.1093/eurheartj/ehl088. Epub 2006 Jun 6.
Results Reference
background
PubMed Identifier
21315210
Citation
Westerhout CM, Bonnefoy E, Welsh RC, Steg PG, Boutitie F, Armstrong PW. The influence of time from symptom onset and reperfusion strategy on 1-year survival in ST-elevation myocardial infarction: a pooled analysis of an early fibrinolytic strategy versus primary percutaneous coronary intervention from CAPTIM and WEST. Am Heart J. 2011 Feb;161(2):283-90. doi: 10.1016/j.ahj.2010.10.033.
Results Reference
derived
Links:
URL
http://www.vigour.ualberta.ca
Description
Canadian VIGOUR Centre Homepage

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

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