Clinical trial NCT00147602: Lipitor In The Prevention Of Stroke, For Patients Who Have Had A Previous Stroke
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 4732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.


Eligibility criteria: Inclusion Criteria:

* Previous stroke or TIA

Exclusion Criteria:

* coronary heart disease

Primary outcomes:
measure: Time to occurrence of fatal or non-fatal stroke
Secondary outcomes:
measure: Time to occurrence of an acute coronary event, consisting of cardiac death, nonfatal myocardial infarction, resuscitated cardiac arrest or unstable angina.
measure: Time to occurrence of a cerebrovascular event, defined as fatal or nonfatal stroke or TIA.
Other outcomes:
Locations:
city: East Gosford
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Randwick, Sydney
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Footscray
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Heidelberg Heights
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Prahran
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Graz
country: Austria
facility: Pfizer Investigational Site
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Villach
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Tielt
country: Belgium
facility: Pfizer Investigational Site
city: Waregem
country: Belgium
facility: Pfizer Investigational Site
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Vina Del Mar
country: Chile
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava-Poruba
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava
country: Czech Republic
facility: Pfizer Investigational Site
city: Pilsen
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague 4
country: Czech Republic
facility: Pfizer Investigational Site
city: Zlin
country: Czech Republic
facility: Pfizer Investigational Site
city: Copenhagen Nv
country: Denmark
facility: Pfizer Investigational Site
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
city: Hellerup
country: Denmark
facility: Pfizer Investigational Site
city: Hus, Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kotka
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Lahti
country: Finland
facility: Pfizer Investigational Site
city: Lappeenranta
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Saint Denis
country: France
facility: Pfizer Investigational Site
state: Cedex 1
city: Paris
country: France
facility: Pfizer Investigational Site
state: Cedex 20
city: Toulouse
country: France
facility: Pfizer Investigational Site
state: Cedex 3
city: Bourg En Bresse
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Besancon
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Bad Rodach
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Minden
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Regensburg
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
state: Melissia
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: Holon
country: Israel
facility: Pfizer Investigational Site
city: Petach-tikva
country: Israel
facility: Pfizer Investigational Site
city: Tel Aviv
country: Israel
facility: Pfizer Investigational Site
city: Via Brunamonti 15
country: Italy
facility: Pfizer Investigational Site
state: Perugia
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Bergamo
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Monza
country: Italy
facility: Pfizer Investigational Site
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
state: GD
city: Almelo
country: Netherlands
facility: Pfizer Investigational Site
city: Delft
country: Netherlands
facility: Pfizer Investigational Site
city: Goes
country: Netherlands
facility: Pfizer Investigational Site
city: RB Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Tilburg
country: Netherlands
facility: Pfizer Investigational Site
city: Takapuna
country: New Zealand
facility: Pfizer Investigational Site
state: Auckland
city: Auckland
country: New Zealand
facility: Pfizer Investigational Site
city: Christchurch
country: New Zealand
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Sosnowiec
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Coimbra Codex
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Parow
country: South Africa
facility: Pfizer Investigational Site
city: L'Hospitalet (BCN)
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: MÃ¡laga
country: Spain
facility: Pfizer Investigational Site
state: Malaga
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Burgos
country: Spain
facility: Pfizer Investigational Site
city: Girona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Danderyd
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Umea
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Vaestervik
country: Sweden
facility: Pfizer Investigational Site
city: Aarau
country: Switzerland
facility: Pfizer Investigational Site
city: Basel
country: Switzerland
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Newport
country: United Kingdom
facility: Pfizer Investigational Site
state: South Wales
city: Aberdeen
country: United Kingdom
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Nottingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Woolwich
country: United Kingdom
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA; Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549-59. doi: 10.1056/NEJMoa061894.
citation: Szarek M, Amarenco P, Callahan A, DeMicco D, Fayyad R, Goldstein LB, Laskey R, Sillesen H, Welch KM; SPARCL Committees and Investigators. Atorvastatin Reduces First and Subsequent Vascular Events Across Vascular Territories: The SPARCL Trial. J Am Coll Cardiol. 2020 May 5;75(17):2110-2118. doi: 10.1016/j.jacc.2020.03.015. Epub 2020 Mar 16.
citation: Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.
citation: Ganz P, Amarenco P, Goldstein LB, Sillesen H, Bao W, Preston GM, Welch KMA; SPARCL Steering Committee. Association of Osteopontin, Neopterin, and Myeloperoxidase With Stroke Risk in Patients With Prior Stroke or Transient Ischemic Attacks: Results of an Analysis of 13 Biomarkers From the Stroke Prevention by Aggressive Reduction in Cholesterol Levels Trial. Stroke. 2017 Dec;48(12):3223-3231. doi: 10.1161/STROKEAHA.117.017965. Epub 2017 Nov 7.
citation: Byun YS, Yang X, Bao W, DeMicco D, Laskey R, Witztum JL, Tsimikas S; SPARCL Trial Investigators. Oxidized Phospholipids on Apolipoprotein B-100 and Recurrent Ischemic Events Following Stroke or Transient Ischemic Attack. J Am Coll Cardiol. 2017 Jan 17;69(2):147-158. doi: 10.1016/j.jacc.2016.10.057.
citation: Amarenco P, Callahan A 3rd, Campese VM, Goldstein LB, Hennerici MG, Messig M, Sillesen H, Welch KM, Wilson DJ, Zivin JA. Effect of high-dose atorvastatin on renal function in subjects with stroke or transient ischemic attack in the SPARCL trial. Stroke. 2014 Oct;45(10):2974-82. doi: 10.1161/STROKEAHA.114.005832. Epub 2014 Aug 21.
citation: Ovbiagele B, Goldstein LB, Amarenco P, Messig M, Sillesen H, Callahan A 3rd, Hennerici MG, Zivin J, Welch KM; SPARCL Investigators. Prediction of major vascular events after stroke: the stroke prevention by aggressive reduction in cholesterol levels trial. J Stroke Cerebrovasc Dis. 2014 Apr;23(4):778-84. doi: 10.1016/j.jstrokecerebrovasdis.2013.12.001. Epub 2014 Feb 24.
citation: Callahan A, Amarenco P, Goldstein LB, Sillesen H, Messig M, Samsa GP, Altafullah I, Ledbetter LY, MacLeod MJ, Scott R, Hennerici M, Zivin JA, Welch KM; SPARCL Investigators. Risk of stroke and cardiovascular events after ischemic stroke or transient ischemic attack in patients with type 2 diabetes or metabolic syndrome: secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Arch Neurol. 2011 Oct;68(10):1245-51. doi: 10.1001/archneurol.2011.146. Epub 2011 Jun 13.
citation: Schwartz GG, Chaitman BR, Goldberger JJ, Messig M. High-dose atorvastatin and risk of atrial fibrillation in patients with prior stroke or transient ischemic attack: analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Am Heart J. 2011 May;161(5):993-9. doi: 10.1016/j.ahj.2011.02.002.
citation: Amarenco P, Goldstein LB, Sillesen H, Benavente O, Zweifler RM, Callahan A 3rd, Hennerici MG, Zivin JA, Welch KM; Stroke Prevention by Aggressive Reduction in Cholesterol Levels Investigators. Coronary heart disease risk in patients with stroke or transient ischemic attack and no known coronary heart disease: findings from the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Stroke. 2010 Mar;41(3):426-30. doi: 10.1161/STROKEAHA.109.564781. Epub 2010 Jan 28.
citation: Amarenco P, Goldstein LB, Callahan A 3rd, Sillesen H, Hennerici MG, O'Neill BJ, Rudolph AE, Simunovic L, Zivin JA, Welch KM; SPARCL Investigators. Baseline blood pressure, low- and high-density lipoproteins, and triglycerides and the risk of vascular events in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Atherosclerosis. 2009 Jun;204(2):515-20. doi: 10.1016/j.atherosclerosis.2008.09.008. Epub 2008 Sep 18.