Lipitor In The Prevention Of Stroke, For Patients Who Have Had A Previous Stroke

NCT00147602 | Completed Phase 4

• 2 other identifiers: 0981-342A2581138
• Study Type: interventional
• Target: 4,732
• Locations: 24 countries
• Sites: 126

Brief Summary

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

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Time to occurrence of fatal or non-fatal stroke

Secondary Outcomes (2)

• Time to occurrence of an acute coronary event, consisting of cardiac death, nonfatal myocardial infarction, resuscitated cardiac arrest or unstable angina.

• Time to occurrence of a cerebrovascular event, defined as fatal or nonfatal stroke or TIA.

Interventions

atorvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous stroke or TIA

You may not qualify if:

• coronary heart disease

Sponsors & Collaborators

• Pfizer: lead

Study Sites (130)

Pfizer Investigational Site

East Gosford, New South Wales, 2250, Australia

Location

Pfizer Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Location

Pfizer Investigational Site

Footscray, Victoria, 3011, Australia

Location

Pfizer Investigational Site

Heidelberg Heights, Victoria, 3081, Australia

Location

Pfizer Investigational Site

Parkville, Victoria, 3050, Australia

Location

Pfizer Investigational Site

Prahran, Victoria, 3181, Australia

Location

Pfizer Investigational Site

Perth, Western Australia, 6000, Australia

Location

Pfizer Investigational Site

Graz, A-8036, Austria

Location

Pfizer Investigational Site

Innsbruck, A-6020, Austria

Location

Pfizer Investigational Site

Vienna, 1160, Austria

Location

Pfizer Investigational Site

Villach, A-9504, Austria

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Tielt, 8700, Belgium

Location

Pfizer Investigational Site

Waregem, 8790, Belgium

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 05403-000, Brazil

Location

Pfizer Investigational Site

Viña del Mar, Chile

Location

Pfizer Investigational Site

Brno, 65691, Czechia

Location

Pfizer Investigational Site

Ostrava, 70384, Czechia

Location

Pfizer Investigational Site

Ostrava-Poruba, 70852, Czechia

Location

Pfizer Investigational Site

Pilsen, 30599, Czechia

Location

Pfizer Investigational Site

Prague, 14021, Czechia

Location

Pfizer Investigational Site

Zlín, 76275, Czechia

Location

Pfizer Investigational Site

Copenhagen Nv, 2400, Denmark

Location

Pfizer Investigational Site

Glostrup Municipality, 2600, Denmark

Location

Pfizer Investigational Site

Hellerup, 2900, Denmark

Location

Pfizer Investigational Site

Hus, Helsinki, 00029, Finland

Location

Pfizer Investigational Site

Kotka, 48210, Finland

Location

Pfizer Investigational Site

Kuopio, 70210, Finland

Location

Pfizer Investigational Site

Lahti, 15850, Finland

Location

Pfizer Investigational Site

Lappeenranta, 53130, Finland

Location

Pfizer Investigational Site

Oulu, 90220, Finland

Location

Pfizer Investigational Site

Saint-Denis, Cedex 1, 93205, France

Location

Pfizer Investigational Site

Paris, Cedex 20, 75970, France

Location

Pfizer Investigational Site

Toulouse, Cedex 3, 31059, France

Location

Pfizer Investigational Site

Bourg-en-Bresse, Cedex, 01012, France

Location

Pfizer Investigational Site

Besançon, 25030, France

Location

Pfizer Investigational Site

Marseille, 13385, France

Location

Pfizer Investigational Site

Nice, 06000, France

Location

Pfizer Investigational Site

Paris, 75018, France

Location

Pfizer Investigational Site

Bad Rodach, 96476, Germany

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Essen, 45122, Germany

Location

Pfizer Investigational Site

Heidelberg, Germany

Location

Pfizer Investigational Site

Leipzig, 04103, Germany

Location

Pfizer Investigational Site

Mannheim, 69135, Germany

Location

Pfizer Investigational Site

Minden, 32427, Germany

Location

Pfizer Investigational Site

München, 81377, Germany

Location

Pfizer Investigational Site

München, 81545, Germany

Location

Pfizer Investigational Site

München, 81675, Germany

Location

Pfizer Investigational Site

Münster, 48149, Germany

Location

Pfizer Investigational Site

Regensburg, 93053, Germany

Location

Pfizer Investigational Site

Athens, Melissia, 15127, Greece

Location

Pfizer Investigational Site

Athens, 11527, Greece

Location

Pfizer Investigational Site

Athens, 15127, Greece

Location

Pfizer Investigational Site

Thessaloniki, 54636, Greece

Location

Pfizer Investigational Site

Thessaloniki, 57010, Greece

Location

Pfizer Investigational Site

Haifa, 34362, Israel

Location

Pfizer Investigational Site

Holon, 58100, Israel

Location

Pfizer Investigational Site

Petah Tikva, 49372, Israel

Location

Pfizer Investigational Site

Tel Aviv, Israel

Location

Pfizer Investigational Site

Via Brunamonti 15, Perugia, 06122, Italy

Location

Pfizer Investigational Site

Bari, 70124, Italy

Location

Pfizer Investigational Site

Bergamo, 24128, Italy

Location

Pfizer Investigational Site

Genova, 16132, Italy

Location

Pfizer Investigational Site

Milan, 20132, Italy

Location

Pfizer Investigational Site

Monza, 20052, Italy

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

Pfizer Investigational Site

Rotterdam, Gelderland, 3015, Netherlands

Location

Pfizer Investigational Site

Almelo, 7609 PP, Netherlands

Location

Pfizer Investigational Site

Delft, 2625 AD, Netherlands

Location

Pfizer Investigational Site

Goes, 4462 RA, Netherlands

Location

Pfizer Investigational Site

RB Groningen, 9700, Netherlands

Location

Pfizer Investigational Site

Tilburg, 5022 GC, Netherlands

Location

Pfizer Investigational Site

Takapuna, Auckland, New Zealand

Location

Pfizer Investigational Site

Auckland, New Zealand

Location

Pfizer Investigational Site

Christchurch, New Zealand

Location

Pfizer Investigational Site

Bialystok, 15-276, Poland

Location

Pfizer Investigational Site

Krakow, 31-503, Poland

Location

Pfizer Investigational Site

Lublin, 20-954, Poland

Location

Pfizer Investigational Site

Poznan, 30-355, Poland

Location

Pfizer Investigational Site

Sosnowiec, 41-200, Poland

Location

Pfizer Investigational Site

Warsaw, 01-211, Poland

Location

Pfizer Investigational Site

Warsaw, 02 - 957, Poland

Location

Pfizer Investigational Site

Wroclaw, 50-420, Poland

Location

Pfizer Investigational Site

Coimbra Codex, 3049, Portugal

Location

Pfizer Investigational Site

Lisbon, 1600, Portugal

Location

Pfizer Investigational Site

Porto, 4000, Portugal

Location

Pfizer Investigational Site

Bratislava, 81369, Slovakia

Location

Pfizer Investigational Site

Bratislava, 83301, Slovakia

Location

Pfizer Investigational Site

Bloemfontein, 9301, South Africa

Location

Pfizer Investigational Site

Cape Town, 7800, South Africa

Location

Pfizer Investigational Site

Parow, 7505, South Africa

Location

Pfizer Investigational Site

Alicante, Alicante, 03010, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08036, Spain

Location

Pfizer Investigational Site

L'Hospitalet (bcn), Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Burgos, Burgos, 09005, Spain

Location

Pfizer Investigational Site

Girona, Girona, 17007, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28006, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28040, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28046, Spain

Location

Pfizer Investigational Site

Málaga, Malaga, 29010, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41009, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41014, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46009, Spain

Location

Pfizer Investigational Site

Zaragoza, Zaragoza, 50009, Spain

Location

Pfizer Investigational Site

Palma de Mallorca, 07014, Spain

Location

Pfizer Investigational Site

Danderyd, 18288, Sweden

Location

Pfizer Investigational Site

Stockholm, 11281, Sweden

Location

Pfizer Investigational Site

Stockholm, 17176, Sweden

Location

Pfizer Investigational Site

Umeå, 90185, Sweden

Location

Pfizer Investigational Site

Uppsala, 75185, Sweden

Location

Pfizer Investigational Site

Västervik, 59381, Sweden

Location

Pfizer Investigational Site

Aarau, 5001, Switzerland

Location

Pfizer Investigational Site

Basel, 4031, Switzerland

Location

Pfizer Investigational Site

Bern, 3010, Switzerland

Location

Pfizer Investigational Site

Lausanne, 1011, Switzerland

Location

Pfizer Investigational Site

Zurich, 8091, Switzerland

Location

Pfizer Investigational Site

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Pfizer Investigational Site

Newport, South Wales, NP20 4SZ, United Kingdom

Location

Pfizer Investigational Site

Aberdeen, AB25 2ZN, United Kingdom

Location

Pfizer Investigational Site

Cardiff, CF4 4XW, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

Pfizer Investigational Site

Liverpool, L9 7AL, United Kingdom

Location

Pfizer Investigational Site

Nottingham, NG5 1PB, United Kingdom

Location

Pfizer Investigational Site

Woolwich, SE18 4HQ, United Kingdom

Location

Pfizer Investigational Site

Caracas, 1041, Venezuela

Location

Related Publications (12)

• 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.

  PMID: 16899775 RESULT

• Chemello K, Gallo A, Guedon AF, Techer R, Croyal M, Swietek MJ, Meilhac O, Amarenco P, Lambert G. Lipoprotein(a): A Residual Cardiovascular Risk Factor in Statin-Treated Stroke Survivors: Insights From the SPARCL Trial. JACC Adv. 2023 Aug 22;2(7):100557. doi: 10.1016/j.jacadv.2023.100557. eCollection 2023 Sep.

  PMID: 38939496 DERIVED

• 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.

  PMID: 32194196 DERIVED

• 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.

  PMID: 31020900 DERIVED

• 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.

  PMID: 29114094 DERIVED

• 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.

  PMID: 28081824 DERIVED

• 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.

  PMID: 25147328 DERIVED

• 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.

  PMID: 24582273 DERIVED

• 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.

  PMID: 21670382 DERIVED

• 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.

  PMID: 21570534 DERIVED

• 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.

  PMID: 20110538 DERIVED

• 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.

  PMID: 18962621 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: November 1, 1998
• Study Completion: November 1, 2005
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

ZA (3); PL (8); BE (4); NL (6); CH (5); VE (1); SE (6); GB (8); AU (7); IL (4); NZ (3); DE (12); CL (1); ES (16); PT (3); SL (2); ME (1); FR (8); DK (3); BR (2); GR (5); IT (6); FI (6); CZ (6)