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

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT00121446

Collaborator

Hoffmann-La Roche (Industry), Sanofi (Industry), Eli Lilly and Company (Industry)

300

Enrollment

Locations

18.8

Patients Per Site

Study Details

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.

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

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Which Early ST Elevation Myocardial Infarction Therapy? The WEST Study

Study Start Date :

Jul 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
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
5	Leduc General Hospital	Leduc	Alberta	Canada
6	Sturgeon Community Health Care Centre	St. Albert	Alberta	Canada
7	Richmond Hospital	Richmond	British Columbia	Canada
8	Surrey Memorial Hospital	Surrey	British Columbia	Canada
9	Lions Gate Hospital	Vancouver	British Columbia	Canada
10	St. Paul's Hospital	Vancouver	British Columbia	Canada
11	Vancouver General Hospital	Vancouver	British Columbia	Canada
12	Dartmouth General Hospital	Dartmouth	Nova Scotia	Canada
13	Queen Elizabeth II Hospital	Halifax	Nova Scotia	Canada
14	Cobequid Community Health Centre Emergency Department	Lower Sackville	Nova Scotia	Canada
15	Montreal Heart Institute	Montreal	Quebec	Canada
16	Pierre Le Gardeur Hospital	Repentigny	Quebec	Canada