Condition category
Circulatory System
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
10/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alastair Mitchell Buchan

ORCID ID

Contact details

Room 1162
Foothills Hospital
1403 - 29th Street N.W.
Calgary
Alberta
T2N 2T9
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00109382

Protocol/serial number

MCT-63529

Study information

Scientific title

Acronym

FASTER

Study hypothesis

1. To determine whether a rapid commencement of clopidogrel plus aspirin (ASA) within 12 hours of acute transient ischemic attack (TIA) or minor stroke is more effective than ASA in reducing the 90-day risk of stroke by an absolute difference of 2%
2. To determine whether a rapid commencement of simvastatin plus ASA within 12 hours of acute TIA or minor stroke is more effective than ASA in reducing the 90-day risk of stroke by an absolute difference of 2%
3. To determine whether a rapid commencement of clopidogrel plus simvastatin plus ASA within 12 hours of acute TIA or minor stroke is more effective than ASA in reducing the 90-day risk of stroke by an absolute difference of 4%
4. To determine whether the incidence of adverse events is different among treatment groups

Ethics approval

Ethics approval received from the Health Research Ethics Board of University of Calgary on the 4th October 2004.

Study design

Multicentre randomised controlled double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Stroke

Intervention

All patients will receive open-label enteric-coated aspirin in the range of 81 mg, with dose determined by the treating physician.
Arm 1: Clopidogrel 300 mg + simvastatin 40 mg on day 1, then clopidogrel 75 mg once daily (OD) + simvastatin 40 mg OD on days 2 - 90
Arm 2: 4 Clopidogrel-placebo tablets + simvastatin 40 mg on day 1, then clopidogrel-placebo tablet OD + simvastatin 40 mg OD on days 2 - 90
Arm 3: Clopidogrel 300 mg + 1 simvastatin-placebo tablet on day 1, then clopidogrel 75 mg OD + 1 simvastatin-placebo tablet OD on days 2 - 90
Arm 4: 4 Clopidogrel-placebo tablets + 1 simvastatin-placebo tablet on day 1, then 1 clopidogrel-placebo tablet OD + 1 simvastatin-placebo tablet OD on days 2 - 90

Intervention type

Drug

Phase

Not Specified

Drug names

Clopidogrel, simvastatin, aspirin

Primary outcome measures

Any stroke within three months.

Secondary outcome measures

Composite of any stroke, myocardial infarction and vascular death.

Overall trial start date

01/04/2003

Overall trial end date

30/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with TIA or minor acute ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] equalling 3 at the time of randomisation) who must not be candidates for acute thrombolytic or anticoagulant therapy within 12 hours of symptom onset
2. Aged 40 years or over, either sex
3. Patients with:
3.1. Weakness at time of TIA/minor stroke and/or language disturbance at time of TIA/minor stroke
3.2. Duration of neurological deficit (TIA) equals 5 minutes
4. Patients can be randomised within 12 hours of symptom onset. Symptom onset is defined by the 'last seen well' principle

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Patients with pure sensory symptoms, pure vertigo or dizziness, or pure visual loss
2. Patients for whom thrombolysis or other acute intervention is indicated as the current standard of care
3. 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
4. Patients, who in the opinion of the site Investigator, should be commenced on statin therapy
5. Patients with neurological deficit due to intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, epidural hematoma), tumor, infection or any finding not consistent with acute brain ischemia as the cause of presenting symptoms
6. Presumed cardiac source of embolus (e.g. atrial fibrillation, prosthetic cardiac valve, known/suspected endocarditis)
7. Patient with a concomitant acute coronary syndrome (acute myocardial infarction or unstable angina)
8. Modified Rankin Score of 3 or more (pre-morbid historical assessment)
9. Patients in whom the qualifying event was due to a complication of cerebral angiography, a revascularization procedure or trauma
10. Uncontrolled hypertension at baseline (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg), or malignant hypertension defined by brain plus other acute organ involvement due to acute hypertension
11. 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
12. Evidence of contraindication for use of Trial Medication:
12.1. Current or past history of severe renal insufficiency
12.2. Current or past history of severe hepatic dysfunction
12.3. Current or past history of thrombocytopenia
12.4. Current or past history of neutropenia
12.5. Current or past history of bleeding diathesis or coagulopathy
12.6. Current or past history of serious systemic bleeding
12.7. Past History of hypersensitivity to aspirin, thienopyridine drugs (clopidogrel or ticlopidine) or statins
13. Life expectancy of less than 90 days
14. Geographical or other factors that render follow-up impractical or that render evaluation of outcome events impossible (e.g. severe dementia). Patients may be randomised who could and are willing to complete their follow-up at another participating centre
15. Participation in another clinical therapeutic trial (drug or device) either concurrently or within the previous 30 days, or prior participation in FASTER

Recruitment start date

01/04/2003

Recruitment end date

30/03/2004

Locations

Countries of recruitment

Canada

Trial participating centre

Room 1162
Calgary, Alberta
T2N 2T9
Canada

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

2500 University Drive N.W.
Calgary
Alberta
T2N 1N4
Canada

Sponsor type

University/education

Website

http://www.ucalgary.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63529)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes