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

NCT00109382 | Completed Phase 2

• 1 other identifier: CSP-100
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 18

Brief 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 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.

Conditions

Transient Ischemic Attack; Stroke

Keywords

Transient Ischemic Attack; Stroke; Stroke Prevention; Recurrence; Neuroprotection; Antiplatelet Therapy; Statins

Outcome Measures

Primary Outcomes (2)

• Any stroke at 90 days

• Stroke severity

Secondary Outcomes (3)

• Composite of stroke

• Myocardial infarction

• Vascular death at 90 days

Interventions

Aspirin DRUG

Clopidogrel DRUG

Simvastatin DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Stroke Consortium (CSC): collaborator

Study Sites (18)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Universtiy of Alberta Walter MacKenzie Health Sciences Centre

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Lethbridge Hospital

Lethbridge, Alberta, T1J 0N9, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 3J5, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Centre for Stroke Research

Victoria, British Columbia, V8R 4R4, Canada

Location

St. John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Queen Elizabeth ll Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, N5A 5A5, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 4A2, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Women's Health Centrre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Mike's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

Toronto Western Hospital -University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Chicoutimi Hospital

Chicoutimi, Quebec, G7H 6B9, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (8)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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)

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 15051694 BACKGROUND

• 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.

  PMID: 17931979 DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient; Stroke; Recurrence

Interventions

Aspirin; Clopidogrel; Simvastatin

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Alastair M Buchan

  Dept of Clinical Neurosciences, University of Calgary

  PRINCIPAL INVESTIGATOR

• James Kennedy

  Nuffield Dept of Clinical Medicine, University of Oxford

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2005
• First Posted: April 27, 2005
• Study Start: May 1, 2003
• Study Completion: February 1, 2007
• Last Updated: April 8, 2008

Record last verified: 2007-06

Locations

US (1); CA (17)