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

NCT00121446 | Completed Phase 2

• 1 other identifier: CVC1002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 16

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.

Conditions

Myocardial Infarction

Keywords

Heart Attack; ST Elevation Myocardial Infarction; fibrinolytic therapy; percutaneous coronary intervention; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (6)

• composite of 6 elements defined by: death

• recurrent myocardial infarction

• heart failure

• cardiogenic shock

• refractory ischemia

• major ventricular arrhythmia

Secondary Outcomes (3)

• 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

Interventions

tenecteplase DRUG

enoxaparin DRUG

clopidogrel DRUG

percutaneous coronary intervention PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Hoffmann-La Roche: collaborator
• Sanofi: collaborator
• Eli Lilly and Company: collaborator

Study Sites (16)

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Location

Misericordia Hospital

Edmonton, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Leduc General Hospital

Leduc, Alberta, Canada

Location

Sturgeon Community Health Care Centre

St. Albert, Alberta, Canada

Location

Richmond Hospital

Richmond, British Columbia, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, Canada

Location

Lions Gate Hospital

Vancouver, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

Location

Queen Elizabeth II Hospital

Halifax, Nova Scotia, Canada

Location

Cobequid Community Health Centre Emergency Department

Lower Sackville, Nova Scotia, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Pierre Le Gardeur Hospital

Repentigny, Quebec, Canada

Location

Related Publications (2)

• 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.

  PMID: 16757491 BACKGROUND

• 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.

  PMID: 21315210 DERIVED

Related Links

• Canadian VIGOUR Centre Homepage

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Tenecteplase; Enoxaparin; Clopidogrel; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Paul W. Armstrong, M.D.

  Canadian VIGOUR Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2005
• First Posted: July 21, 2005
• Study Start: July 1, 2003
• Last Updated: May 19, 2017

Record last verified: 2005-07

Locations

CA (16)