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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00147602




Registration number
NCT00147602
Ethics application status
Date submitted
6/09/2005
Date registered
7/09/2005
Date last updated
22/04/2015

Titles & IDs
Public title
Lipitor In The Prevention Of Stroke, For Patients Who Have Had A Previous Stroke
Scientific title
A Double-Blind, Randomized, Placebo- Controlled Study Of Atorvastatin As Prevention Of Cerebrovascular Events In Patients With A Previous Transient Ischemic Attack (TIA) Or Stroke
Secondary ID [1] 0 0
A2581138
Secondary ID [2] 0 0
0981-342
Universal Trial Number (UTN)
Trial acronym
SPARCL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - atorvastatin

Treatment: Drugs: atorvastatin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to occurrence of fatal or non-fatal stroke
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time to occurrence of an acute coronary event, consisting of cardiac death, nonfatal myocardial infarction, resuscitated cardiac arrest or unstable angina.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Time to occurrence of a cerebrovascular event, defined as fatal or nonfatal stroke or TIA.
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Previous stroke or TIA
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- coronary heart disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - East Gosford
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Randwick, Sydney
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Footscray
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Heidelberg Heights
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Parkville
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Prahran
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2250 - East Gosford
Recruitment postcode(s) [2] 0 0
2031 - Randwick, Sydney
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
3181 - Prahran
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
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Graz
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Austria
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Innsbruck
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Austria
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Villach
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Austria
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Wien
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Tielt
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Belgium
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Waregem
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Brazil
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RS
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Brazil
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SP
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Chile
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Vina Del Mar
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Czech Republic
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Brno
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Czech Republic
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Ostrava-Poruba
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Czech Republic
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Ostrava
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Czech Republic
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Pilsen
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Czech Republic
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Prague 4
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Czech Republic
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Zlin
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Denmark
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Copenhagen Nv
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Denmark
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Glostrup
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Denmark
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Hellerup
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Finland
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Hus, Helsinki
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Finland
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Kotka
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Finland
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Kuopio
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Finland
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Lahti
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Finland
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Lappeenranta
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Finland
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Oulu
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France
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Cedex 1
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France
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Cedex 20
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France
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Cedex 3
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France
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Cedex
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France
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Besancon
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France
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Marseille
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France
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Nice
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Paris
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Germany
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Bad Rodach
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Berlin
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Germany
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Essen
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Mannheim
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Germany
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Minden
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Germany
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Muenchen
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Germany
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Muenster
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Germany
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Regensburg
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Greece
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Melissia
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Athens
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Greece
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Thessaloniki
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Israel
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Haifa
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Israel
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Holon
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Israel
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Petach-tikva
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Israel
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Tel Aviv
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Italy
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Perugia
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Bari
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Italy
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Bergamo
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Genova
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Milano
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Monza
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Nuevo Leon
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GD
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Almelo
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Delft
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Goes
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Netherlands
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RB Groningen
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Netherlands
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Tilburg
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Auckland
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Wroclaw
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Portugal
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Coimbra Codex
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Lisboa
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Portugal
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Porto
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Bratislava
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Bloemfontein
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Cape Town
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Parow
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Barcelona
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Malaga
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Alicante
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Burgos
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Girona
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Danderyd
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Uppsala
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Sweden
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Vaestervik
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Switzerland
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Aarau
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Lausanne
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Switzerland
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Zurich
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United Kingdom
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Scotland
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United Kingdom
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South Wales
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United Kingdom
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Aberdeen
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United Kingdom
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Cardiff
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United Kingdom
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Glasgow
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United Kingdom
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Liverpool
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United Kingdom
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Nottingham
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United Kingdom
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Woolwich
Country [109] 0 0
Venezuela
State/province [109] 0 0
Caracas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a
previous stroke or transient ischemic attack.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00147602
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00147602