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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
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
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Austria
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Innsbruck
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Austria
State/province [3] 0 0
Villach
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Austria
State/province [4] 0 0
Wien
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Belgium
State/province [5] 0 0
Gent
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Belgium
State/province [6] 0 0
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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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
State/province [23] 0 0
Kuopio
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Finland
State/province [24] 0 0
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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France
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Paris
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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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Athens
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Thessaloniki
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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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Bergamo
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Burgos
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Girona
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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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Uppsala
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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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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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Aberdeen
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Cardiff
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Glasgow
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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/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
Other publications