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Myocardial InfarctionPhase 2/3NCT00121446

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

A Phase 2/3 study testing tenecteplase, enoxaparin and clopidogrel in people with Myocardial Infarction, run by University of Alberta at 16 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
tenecteplase, enoxaparin and clopidogrel
Type of treatment
Surgery or procedure
How many people
300 participants
Where
16 sitesCanada
Study dates
Jul 2003to not given
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 20Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Canada16 sites

  • Dartmouth General Hospital

    Dartmouth, Nova Scotia

  • Grey Nuns Community Hospital

    Edmonton, Alberta

  • Misericordia Hospital

    Edmonton, Alberta

  • Royal Alexandra Hospital

    Edmonton, Alberta

  • University of Alberta Hospital

    Edmonton, Alberta

  • Queen Elizabeth II Hospital

    Halifax, Nova Scotia

  • Leduc General Hospital

    Leduc, Alberta

  • Cobequid Community Health Centre Emergency Department

    Lower Sackville, Nova Scotia

  • Montreal Heart Institute

    Montreal, Quebec

  • Pierre Le Gardeur Hospital

    Repentigny, Quebec

  • Richmond Hospital

    Richmond, British Columbia

  • Sturgeon Community Health Care Centre

    St. Albert, Alberta

  • Surrey Memorial Hospital

    Surrey, British Columbia

  • Lions Gate Hospital

    Vancouver, British Columbia

  • St. Paul's Hospital

    Vancouver, British Columbia

  • Vancouver General Hospital

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
tenecteplase, enoxaparin, clopidogrel, percutaneous coronary intervention
Keywords
Heart Attack, ST Elevation Myocardial Infarction, fibrinolytic therapy, percutaneous coronary intervention, Acute Myocardial Infarction
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tenecteplaseDrug

  • enoxaparinDrug

  • clopidogrelDrug

  • percutaneous coronary interventionProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. composite of 6 elements defined by: death

  2. recurrent myocardial infarction

  3. heart failure

  4. cardiogenic shock

  5. refractory ischemia

  6. major ventricular arrhythmia

Secondary outcomes (3)

  1. 90 and 180 minute ECG ST resolution

  2. QRS determined infarct size at discharge/day 7

  3. CK infarct size determined by area under the curve or peak CK-MB

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2005 (estimated)
  2. Study startJul 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121446
Sponsor's protocol ID
CVC1002
Status last verified
Jul 2005
First submitted
13 Jul 2005
Last updated
19 May 2017
Results posted
No

Publications

  • 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.

    PubMed 16757491

  • 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.

    PubMed 21315210

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tenecteplase, enoxaparin and clopidogrel in people with Myocardial Infarction, run by University of Alberta at 16 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite of 6 elements defined by: death. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00121446, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.

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