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Transient Ischemic AttackPhase 2/3NCT00109382

Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence (FASTER)

A Phase 2/3 study testing Aspirin, Clopidogrel and Simvastatin in people with Transient Ischemic Attack and Stroke, run by University of Calgary at 18 sites in 2 countries.

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

Current management of patients with TIA (transient ischemic attack) or minor stroke includes the prompt investigation and treatment in the days and weeks after the event. However, new evidence shows patients are at the highest risk of stroke in the first few days after the TIA, with 50% of strokes which happen in the… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Transient Ischemic Attack, Stroke
What is being tested?
Aspirin, Clopidogrel and Simvastatin
How many people
500 participants
Where
18 sitesin 2 countries
Study dates
May 2003to Feb 2007
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with TIA or minor acute ischemic stroke (NIHSS < 4 at the time of randomization) who must NOT be candidates for acute thrombolysis or other acute intervention indicated as the current standard of care
  • Aged 40 years or older
  • Patients with: (a) weakness at time of TIA/minor stroke and/or language disturbance at time of TIA/minor stroke and; (b) duration of neurological deficit (TIA) > 5 minutes
  • Patients can be randomized within 24 hours of symptom onset. Symptom onset is defined by the "last seen well" principle
  • Patients must have provided written, informed consent to participate in the FASTER trial.

Who cannot join

  • Patients with pure sensory symptoms, pure vertigo or dizziness, pure ataxia or pure visual loss
  • Patients for whom thrombolysis or other acute intervention is indicated as the current standard of care
  • Patients who are currently on statin therapy, antiplatelet therapy (not including aspirin), or long-term non-steroidal anti-inflammatory drugs (NSAIDs but not COX inhibitors), or anticoagulation
  • Patients who in the opinion of the site Investigator, should be commenced on statin therapy
  • Patients with neurological deficit due to intracranial hemorrhage (intracranial hemorrhage, subarachnoid hemorrhage, subdural hematoma, epidural hematoma), tumor, infection or any finding not consistent with acute brain ischemia as the cause of presenting symptoms
  • Presumed cardiac source of embolus (e.g. atrial fibrillation, prosthetic cardiac valve, known/suspected endocarditis)
Show all 15Show fewer
  • Patient with a concomitant acute coronary syndrome (acute myocardial infarction or unstable angina)
  • Modified Rankin Score 3 or more (pre-morbid historical assessment)
  • Patients in whom the qualifying event was due to a complication of cerebral angiography, a revascularization procedure or trauma
  • Uncontrolled hypertension at baseline (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg), or malignant hypertension defined by brain plus acute organ involvement due to acute hypertension
  • Women who are breast-feeding or pregnant. Women of childbearing potential must have a negative pregnancy test prior to randomization. Women of childbearing potential may still participate in the trial but must plan on not becoming pregnant during the course of the study and must practice a suitable method of birth control. If a patient becomes pregnant or begins breast-feeding during the study, both study drugs will be discontinued immediately, and the patient followed for the duration of the study
  • Evidence of contraindication for use of Trial Medication: (i) serious systemic bleeding precluding antiplatelet therapy; (ii) hypersensitivity to aspirin, thienopyridine drugs (clopidogrel or ticlopidine) or statins; (iii) current or past history of renal insufficiency [serum Creatinine >150 umol]; (iv) hepatic dysfunction indicated by any or all of the following [ALT >3xULN, AST >3xULN, ALP >3xULN]; (v) thrombocytopenia [platelet count < 150 x10^9/L]; (vi) neutropenia [neutrophil count < 0.5 x10^9/L]; (vii) bleeding diathesis or coagulopathy indicated by any or all of the following [INR >1.2, PT >1.2xULN, PTT >1.2xULN]
  • Life expectancy of less than 90 days
  • Participation in another clinical therapeutic trial (drug or device) either concurrently or within the previous 30 days, or prior participation in FASTER
  • Geographical or other factors that render follow-up impractical or that render evaluation of outcome events impossible (e.g. severe dementia). Patients may be randomized who could and are willing to complete their follow-up at a participating centre

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

Canada17 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Chicoutimi Hospital

    Chicoutimi, Quebec, G7H 6B9

  • Universtiy of Alberta Walter MacKenzie Health Sciences Centre

    Edmonton, Alberta, T6G 2B7

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • Queen Elizabeth ll Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • University of Lethbridge Hospital

    Lethbridge, Alberta, T1J 0N9

  • London Health Sciences Centre - University Hospital

    London, Ontario, N5A 5A5

  • Trillium Health Centre

    Mississauga, Ontario, L5B 4A2

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • St. John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Sunnybrook Women's Health Centrre

    Toronto, Ontario, M4N 3M5

  • St. Mike's Hospital

    Toronto, Ontario, M5C 1R6

  • Toronto Western Hospital -University Health Network

    Toronto, Ontario, M5T 2S8

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 3J5

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Centre for Stroke Research

    Victoria, British Columbia, V8R 4R4

Other trials in Canada

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Current management of patients with TIA (transient ischemic attack) or minor stroke includes the prompt investigation and treatment in the days and weeks after the event. However, new evidence shows patients are at the highest risk of stroke in the first few days after the TIA, with 50% of strokes which happen in the three months following TIA occurring within 48-72 hours. To date, there is no evidence to guide physicians on how to safely reduce this risk.

The FASTER trial is focusing on the initial period of high risk, starting patients on stroke prevention treatments in the hours following a TIA or minor stroke. The drugs to be tested have been shown to be effective in the similar setting of cardiology, reducing recurrent cardiac events in patients with unstable angina when commenced with the same speed after an event.

All patients will be on aspirin. The trial will see if adding another drug, clopidogrel, has an additional benefit in reducing the number of strokes after TIA or minor stroke within three months of TIA or minor stroke. It will also look if the very early introduction of simvastatin, a cholesterol lowering therapy, reduces stroke after TIA or minor stroke, both by itself and in addition to clopidogrel. The final aim of the trial is to ensure that these treatments are safe to be used in this population of patients.

Read the detailed description

The Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence (FASTER) is a randomized clinical trial designed to investigate the effect of hyper-acute initiation of stroke prevention treatments in patients with a minor stroke or transient ischemic attack (TIA).

This group of individuals has been recognized as being at high risk of recurrent events. Johnston et al. (2000) were the first to suggest that the risk of stroke after TIA was front-loaded in the first few days. This has been confirmed elsewhere with Lovett et al. (2003) having shown in the Oxfordshire Community Stroke Project that the 7-day risk of recurrent stroke was 8.6%, and a 30-day risk of 12.0%. These findings are similarly found in the Oxford Vascular Study; 8.0% and 11.5% respectively for a recurrent event (Coull et al., 2004). The NASCET (North American Symptomatic Carotid Endarterectomy Trial) study also supports the finding of high risk of early recurrent stroke. 8.5% of patients with a hemispheric TIA suffered a recurrent stroke within one week rising to 20% at 90-days (Eliasziw et al., 2004). This data suggest that patients with carotid stenosis are at the highest risk of early recurrent stoke.

Only one in four patients with acute ischemic stroke presenting within three hours of symptom onset are being treated with t-PA (Barber et al., 2001). The most common reason for exclusion from treatment is that a patient's deficit will be too mild for treatment or will have completely resolved thereby not meriting the risks of treatment with tPA. These are the patients that have a higher risk of early recurrence. The clinical imperative is to identify hyper-acute treatment strategies to minimize that risk.

FASTER is a double blind, randomized controlled trial with a 2x2 factorial design with patients followed for 90-days. Patients will be randomized within 24 hours of symptom onset to one of four possible treatment arms:

  • Aspirin
  • Aspirin and Clopidogrel
  • Aspirin and Simvastatin
  • Aspirin and Clopidogrel and Simvastatin

Study Hypotheses

  1. A rapid commencement of clopidogrel plus aspirin within 24 hours of acute TIA or minor stroke is more effective than aspirin in reducing the 90-day risk of stroke by an absolute difference of 2%.
  2. A rapid commencement of simvastatin plus aspirin within 24 hours of acute TIA or minor stroke is more effective than aspirin in reducing the 90-day risk of stroke by an absolute difference of 2%.
  3. A rapid commencement of clopidogrel plus aspirin plus simvastatin within 24 hours of acute TIA or minor stroke is more effective than aspirin alone in reducing the 90-day risk of stroke by an absolute difference of 4%.
  4. The incidence of adverse events is not different among treatment groups.
Keywords
Transient Ischemic Attack, Stroke, Stroke Prevention, Recurrence, Neuroprotection, Antiplatelet Therapy, Statins
Medical subject headings
Ischemic Attack, Transient, Stroke, Recurrence

What participants receive

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

What is being measured

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

  1. Any stroke at 90 days

  2. Stroke severity

Secondary outcomes (3)

  1. Composite of stroke

  2. Myocardial infarction

  3. Vascular death at 90 days

Timeline

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

  1. First posted27 Apr 2005 (estimated)
  2. Study startMay 2003
  3. Study completionFeb 2007

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
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109382
Sponsor's protocol ID
CSP-100
Status last verified
Jun 2007
First submitted
27 Apr 2005
Last updated
8 Apr 2008
Results posted
No

Publications

  • Palumbo V, Eliasziw M, Buchan AM, on behalf of the FASTER Investigators. Urgent Stroke Imaging is also Feasible for Secondary Prevention Trial. 28th International Conference on Stroke and Cerebral Circulation, American Heart Association Stroke Conference. Clinical Trials Abstract. Accepted as Poster Presentation. 2003

  • Kennedy J, Eliasziw M, Buchan AM on behalf of the FASTER Collaborators. The Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence (FASTER) Trial. 28th International Conference on Stroke and Cerebral Circulation, American Heart Association Stroke Conference. Clinical Trials Abstract. http://www.strokeconference.org/sc_includes/pdfs/CTP24.pdf Accepted as Poster Presentation. 2003

  • Kennedy J, Eliasziw M, Hill MD, Buchan AM. The Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence (FASTER) Trial. Seminars in Cerebrovascular Diseases and Stroke, March 2003 Ed. J. Biller. Vol 3/1 pp 25-30. 2003

  • Kennedy J, Eliasziw M, Buchan AM on behalf of the FASTER Investigators. The Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence (FASTER) Trial. 29th International Conference on Stroke and Cerebral Circulation, American Heart Association Stroke Conference. Clinical Trials Abstract. Accepted as Poster Presentation. 2004

  • Kennedy J, Ma C, Buchan AM. FASTER prevention, fastest neuroprotection. Pharmacology of Cerebral Ischemia, Proceedings of the Marburg Conference 2004. Ed. J Krigelstein. (In Press)

  • Kennedy J, Buchan AM on behalf of the FASTER Investigators. The Fast Assessment of Stroke and Transient ischemic attack to prevent Early Recurrence (FASTER) Trial. 30th International Conference on Stroke and Cerebral Circulation, American Heart Association Stroke Conference. Clinical Trials Abstract. Accepted as Poster Presentation. 2005

  • Eliasziw M, Kennedy J, Hill MD, Buchan AM, Barnett HJ; North American Symptomatic Carotid Endarterectomy Trial Group. Early risk of stroke after a transient ischemic attack in patients with internal carotid artery disease. CMAJ. 2004 Mar 30;170(7):1105-9. doi: 10.1503/cmaj.1030460.

    PubMed 15051694

  • Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. doi: 10.1016/S1474-4422(07)70250-8. Epub 2007 Oct 10.

    PubMed 17931979

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Aspirin, Clopidogrel and Simvastatin in people with Transient Ischemic Attack and Stroke, run by University of Calgary at 18 sites in 2 countries.

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 15 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 8 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Canada, United States. 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?

Any stroke at 90 days. The study lists 2 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 NCT00109382, which also lists 8 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 8 Apr 2008.

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