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

NCT ID: NCT00147602

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

4732 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Study Completion Date

2005-11-30

Brief Summary

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

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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atorvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previous stroke or TIA

Exclusion Criteria

* coronary heart disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

East Gosford, New South Wales, Australia

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Randwick, Sydney, New South Wales, Australia

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Footscray, Victoria, Australia

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Heidelberg Heights, Victoria, Australia

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Parkville, Victoria, Australia

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Prahran, Victoria, Australia

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Perth, Western Australia, Australia

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Graz, , Austria

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Innsbruck, , Austria

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Vienna, , Austria

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Villach, , Austria

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Ghent, , Belgium

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Leuven, , Belgium

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Tielt, , Belgium

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Waregem, , Belgium

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Viña del Mar, , Chile

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Brno, , Czechia

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Ostrava, , Czechia

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Ostrava-Poruba, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Zlín, , Czechia

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Copenhagen Nv, , Denmark

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Glostrup Municipality, , Denmark

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Hellerup, , Denmark

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Hus, Helsinki, , Finland

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Kotka, , Finland

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Kuopio, , Finland

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Lahti, , Finland

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Lappeenranta, , Finland

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Oulu, , Finland

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Saint-Denis, Cedex 1, France

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Paris, Cedex 20, France

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Toulouse, Cedex 3, France

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Bourg-en-Bresse, Cedex, France

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Besançon, , France

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Marseille, , France

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Nice, , France

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Paris, , France

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Bad Rodach, , Germany

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Berlin, , Germany

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Essen, , Germany

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Heidelberg, , Germany

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Leipzig, , Germany

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Mannheim, , Germany

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Minden, , Germany

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München, , Germany

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München, , Germany

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München, , Germany

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Münster, , Germany

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Regensburg, , Germany

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Athens, Melissia, Greece

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Athens, , Greece

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Athens, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Haifa, , Israel

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Holon, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Via Brunamonti 15, Perugia, Italy

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Bari, , Italy

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Bergamo, , Italy

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Genova, , Italy

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Milan, , Italy

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Monza, , Italy

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Monterrey, Nuevo León, Mexico

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Rotterdam, Gelderland, Netherlands

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Almelo, , Netherlands

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Delft, , Netherlands

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Goes, , Netherlands

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RB Groningen, , Netherlands

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Tilburg, , Netherlands

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Takapuna, Auckland, New Zealand

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Bialystok, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Sosnowiec, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Coimbra Codex, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Parow, , South Africa

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Alicante, Alicante, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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L'Hospitalet (bcn), Barcelona, Spain

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Burgos, Burgos, Spain

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Girona, Girona, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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Seville, Sevilla, Spain

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Seville, Sevilla, Spain

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Zaragoza, Zaragoza, Spain

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Palma de Mallorca, , Spain

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Danderyd, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Västervik, , Sweden

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Aarau, , Switzerland

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Basel, , Switzerland

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Bern, , Switzerland

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Lausanne, , Switzerland

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Zurich, , Switzerland

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Dundee, Scotland, United Kingdom

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Newport, South Wales, United Kingdom

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Aberdeen, , United Kingdom

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Cardiff, , United Kingdom

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Glasgow, , United Kingdom

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Liverpool, , United Kingdom

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Nottingham, , United Kingdom

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Woolwich, , United Kingdom

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Caracas, , Venezuela

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Countries

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Australia Austria Belgium Brazil Chile Czechia Denmark Finland France Germany Greece Israel Italy Mexico Netherlands New Zealand Poland Portugal Slovakia South Africa Spain Sweden Switzerland United Kingdom Venezuela

References

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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.

Reference Type RESULT
PMID: 16899775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38939496 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32194196 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31020900 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29114094 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28081824 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25147328 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24582273 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21670382 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21570534 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20110538 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18962621 (View on PubMed)

Other Identifiers

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A2581138

Identifier Type: -

Identifier Source: secondary_id

0981-342

Identifier Type: -

Identifier Source: org_study_id

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