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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Villach
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Tielt
Country [8] 0 0
Belgium
State/province [8] 0 0
Waregem
Country [9] 0 0
Brazil
State/province [9] 0 0
RS
Country [10] 0 0
Brazil
State/province [10] 0 0
SP
Country [11] 0 0
Chile
State/province [11] 0 0
Vina Del Mar
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Brno
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Ostrava-Poruba
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Ostrava
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Pilsen
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Prague 4
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Zlin
Country [18] 0 0
Denmark
State/province [18] 0 0
Copenhagen Nv
Country [19] 0 0
Denmark
State/province [19] 0 0
Glostrup
Country [20] 0 0
Denmark
State/province [20] 0 0
Hellerup
Country [21] 0 0
Finland
State/province [21] 0 0
Hus, Helsinki
Country [22] 0 0
Finland
State/province [22] 0 0
Kotka
Country [23] 0 0
Finland
State/province [23] 0 0
Kuopio
Country [24] 0 0
Finland
State/province [24] 0 0
Lahti
Country [25] 0 0
Finland
State/province [25] 0 0
Lappeenranta
Country [26] 0 0
Finland
State/province [26] 0 0
Oulu
Country [27] 0 0
France
State/province [27] 0 0
Cedex 1
Country [28] 0 0
France
State/province [28] 0 0
Cedex 20
Country [29] 0 0
France
State/province [29] 0 0
Cedex 3
Country [30] 0 0
France
State/province [30] 0 0
Cedex
Country [31] 0 0
France
State/province [31] 0 0
Besancon
Country [32] 0 0
France
State/province [32] 0 0
Marseille
Country [33] 0 0
France
State/province [33] 0 0
Nice
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
Germany
State/province [35] 0 0
Bad Rodach
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Essen
Country [38] 0 0
Germany
State/province [38] 0 0
Heidelberg
Country [39] 0 0
Germany
State/province [39] 0 0
Leipzig
Country [40] 0 0
Germany
State/province [40] 0 0
Mannheim
Country [41] 0 0
Germany
State/province [41] 0 0
Minden
Country [42] 0 0
Germany
State/province [42] 0 0
Muenchen
Country [43] 0 0
Germany
State/province [43] 0 0
Muenster
Country [44] 0 0
Germany
State/province [44] 0 0
Regensburg
Country [45] 0 0
Greece
State/province [45] 0 0
Melissia
Country [46] 0 0
Greece
State/province [46] 0 0
Athens
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
Country [48] 0 0
Israel
State/province [48] 0 0
Haifa
Country [49] 0 0
Israel
State/province [49] 0 0
Holon
Country [50] 0 0
Israel
State/province [50] 0 0
Petach-tikva
Country [51] 0 0
Israel
State/province [51] 0 0
Tel Aviv
Country [52] 0 0
Italy
State/province [52] 0 0
Perugia
Country [53] 0 0
Italy
State/province [53] 0 0
Bari
Country [54] 0 0
Italy
State/province [54] 0 0
Bergamo
Country [55] 0 0
Italy
State/province [55] 0 0
Genova
Country [56] 0 0
Italy
State/province [56] 0 0
Milano
Country [57] 0 0
Italy
State/province [57] 0 0
Monza
Country [58] 0 0
Mexico
State/province [58] 0 0
Nuevo Leon
Country [59] 0 0
Netherlands
State/province [59] 0 0
GD
Country [60] 0 0
Netherlands
State/province [60] 0 0
Almelo
Country [61] 0 0
Netherlands
State/province [61] 0 0
Delft
Country [62] 0 0
Netherlands
State/province [62] 0 0
Goes
Country [63] 0 0
Netherlands
State/province [63] 0 0
RB Groningen
Country [64] 0 0
Netherlands
State/province [64] 0 0
Tilburg
Country [65] 0 0
New Zealand
State/province [65] 0 0
Auckland
Country [66] 0 0
New Zealand
State/province [66] 0 0
Christchurch
Country [67] 0 0
Poland
State/province [67] 0 0
Bialystok
Country [68] 0 0
Poland
State/province [68] 0 0
Krakow
Country [69] 0 0
Poland
State/province [69] 0 0
Lublin
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Poland
State/province [70] 0 0
Poznan
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Poland
State/province [71] 0 0
Sosnowiec
Country [72] 0 0
Poland
State/province [72] 0 0
Warszawa
Country [73] 0 0
Poland
State/province [73] 0 0
Wroclaw
Country [74] 0 0
Portugal
State/province [74] 0 0
Coimbra Codex
Country [75] 0 0
Portugal
State/province [75] 0 0
Lisboa
Country [76] 0 0
Portugal
State/province [76] 0 0
Porto
Country [77] 0 0
Slovakia
State/province [77] 0 0
Bratislava
Country [78] 0 0
South Africa
State/province [78] 0 0
Bloemfontein
Country [79] 0 0
South Africa
State/province [79] 0 0
Cape Town
Country [80] 0 0
South Africa
State/province [80] 0 0
Parow
Country [81] 0 0
Spain
State/province [81] 0 0
Barcelona
Country [82] 0 0
Spain
State/province [82] 0 0
Malaga
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Spain
State/province [83] 0 0
Alicante
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Spain
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Burgos
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Spain
State/province [85] 0 0
Girona
Country [86] 0 0
Spain
State/province [86] 0 0
Madrid
Country [87] 0 0
Spain
State/province [87] 0 0
Palma de Mallorca
Country [88] 0 0
Spain
State/province [88] 0 0
Sevilla
Country [89] 0 0
Spain
State/province [89] 0 0
Valencia
Country [90] 0 0
Spain
State/province [90] 0 0
Zaragoza
Country [91] 0 0
Sweden
State/province [91] 0 0
Danderyd
Country [92] 0 0
Sweden
State/province [92] 0 0
Stockholm
Country [93] 0 0
Sweden
State/province [93] 0 0
Umea
Country [94] 0 0
Sweden
State/province [94] 0 0
Uppsala
Country [95] 0 0
Sweden
State/province [95] 0 0
Vaestervik
Country [96] 0 0
Switzerland
State/province [96] 0 0
Aarau
Country [97] 0 0
Switzerland
State/province [97] 0 0
Basel
Country [98] 0 0
Switzerland
State/province [98] 0 0
Bern
Country [99] 0 0
Switzerland
State/province [99] 0 0
Lausanne
Country [100] 0 0
Switzerland
State/province [100] 0 0
Zurich
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Scotland
Country [102] 0 0
United Kingdom
State/province [102] 0 0
South Wales
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Aberdeen
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Cardiff
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Glasgow
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Liverpool
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Nottingham
Country [108] 0 0
United Kingdom
State/province [108] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Amarenco P, Bogousslavsky J, Callahan A 3rd, Golds... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00147602