Secondary Prevention of Small Subcortical Strokes Trial

NCT ID: NCT00059306

Last Updated: 2013-04-04

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

PHASE3

Total Enrollment

3020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2012-04-30

Brief Summary

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The goal of this study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for the prevention of recurrent stroke and cognitive decline, and if intensive blood pressure control is associated with fewer recurrent strokes and cognitive decline.

On July 21, 2011 the DSMB recommended terminating the anti platelet arm of the study due to an imbalance of overall and major non-CNS hemorrhagic SAE's and total deaths in the investigational anti platelet combination of aspirin + clopidogrel and an interim statistical analysis that demonstrated futility in the investigational anti platelet arm. It was recommended that patients be continued on standard care of aspirin mono therapy until their study close-out visit. Also, recommended the continuation and completion of the plood pressure arm following the protocol.

Detailed Description

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Stroke is damage to the brain caused by problems in the blood vessels. Strokes often cause paralysis, loss of sensation and speech, and other problems. A lacunar or small Subcortical stroke affects the inner part of the brain causing small "pea sized" areas of damage due to blockage of small blood vessels within the brain.

This multi-center study will recruit 3000 participants (20 percent of whom will be Hispanic) to find out if using aspirin and clopidogrel is more effective than using aspirin alone to prevent recurrent stroke in patients with lacunar stroke confirmed by MRI, and if lowering a patient's blood pressure below the usual limits will also help prevent recurrent stroke and maintain thinking ability. Both aspirin and clopidogrel are widely-used for blood clotting and stroke prevention. Investigators intend to find out if using the drugs together is more effective than using aspirin alone.

Participants will be randomly assigned to one of 2 types of treatment: either aspirin alone or the combination of aspirin and clopidogrel. In addition, participants will be assigned to one of 2 groups of blood pressure control. The difference between the two groups is the target level of systolic blood pressure-either 130-149 or below 130. The goal of the blood pressure aspect of this trial is to find out if lowering blood pressure after stroke helps to prevent recurrent stroke and preserves cognition.

Conditions

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Cerebrovascular Accident Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Antiplatelet

Participants receive aspirin + placebo OR aspirin + clopidogrel

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

Participants receive aspirin + placebo, specifically: aspirin (325 mg) with placebo (an inactive substance). Participants will take 1 of each pill a day until the end of the study.

clopidogrel

Intervention Type DRUG

Participants will receive aspirin + clopidogrel, specifically: aspirin (325 mg) with clopidogrel (75 mg)-- Participants will take 1 of each pill a day until the end of the study.

placebo

Intervention Type OTHER

an inactive substance

Blood pressure

The goal of the blood pressure aspect of this trial is to find out if lowering blood pressure after stroke helps to prevent recurrent stroke and preserves cognition.

Group Type ACTIVE_COMPARATOR

Target of Blood Pressure

Intervention Type OTHER

Participants will be assigned to one of 2 groups of blood pressure control. The difference between the two groups is the target level of systolic blood pressure-either 130-149 mmHg or below 130 mmHg; to do so, the scientists will use medications that are already in the market for blood pressure management.

Interventions

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aspirin

Participants receive aspirin + placebo, specifically: aspirin (325 mg) with placebo (an inactive substance). Participants will take 1 of each pill a day until the end of the study.

Intervention Type DRUG

clopidogrel

Participants will receive aspirin + clopidogrel, specifically: aspirin (325 mg) with clopidogrel (75 mg)-- Participants will take 1 of each pill a day until the end of the study.

Intervention Type DRUG

Target of Blood Pressure

Participants will be assigned to one of 2 groups of blood pressure control. The difference between the two groups is the target level of systolic blood pressure-either 130-149 mmHg or below 130 mmHg; to do so, the scientists will use medications that are already in the market for blood pressure management.

Intervention Type OTHER

placebo

an inactive substance

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Small subcortical ischemic stroke or subcortical TIA.


* One of the lacunar stroke clinical syndromes (adapted from Fisher) lasting \> 24 hrs within the past 6 months
* Absence of signs or symptoms of cortical dysfunction such as aphasia, apraxia, agnosia, agraphia, homonymous visual field defect, etc.
* No ipsilateral cervical carotid stenosis (≥50%) by a reliable imaging modality done in an approved laboratory since the qualifying small subcortical stroke (S3), if hemispheric.
* No major-risk cardioembolic sources requiring anticoagulation or other specific therapy. Minor-risk cardioembolic sources will be permitted if anticoagulation is not prescribed by the patient's primary care physician.
* Subcortical TIA with corresponding lesion on DWI.
* MRI evidence of S3: a. Presence of an S3 (1.5 and 2 cm in diameter corresponding to the qualifying event on DWI; when TIA, ADC image must confirm lesion or T2/FLAIR (hyperintense lesions) (required for all brainstem events) OR multiple S3s on FLAIR/TI(\<1.5 cm in diameter) (hypointense lesions) b. Absence of cortical stroke and large subcortical stroke (recent or remote).

EXCLUSION:

To be eligible for entry into the study, the patient must not meet any of the criteria listed below:

* Disabling stroke (Modified Rankin Scale less than or equal to 4)
* Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
* Age under 30 years
* High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc)
* Anticipated requirement for long-term use of anticoagulants (e.g. recurrent DVT) or other antiplatelets
* Prior cortical stroke (diagnosed either clinically or by neuroimaging), or prior cortical or retinal TIA
* Prior ipsilateral carotid endarterectomy
* Impaired renal function: GFR \<40
* Intolerance or contraindications to aspirin or clopidogrel (including thrombocytopenia, prolonged INR)
* A score \< 24 (adjusted for age and education) on the Folstein Mini Mental Status Examination
* Medical contraindication to MRI
* Pregnancy or women of child-bearing potential who are not following an effective method of contraception
* Geographic or social factors making study participation impractical
* Unable or unwilling to provide informed consent
* Unlikely to be compliant with therapy/unwilling to return for frequent clinic visits
* Patients concurrently participating in another study with an investigational drug or device
* Other likely specific cause of stroke (e.g. dissection, vasculitis, prothrombotic diathesis, drug abuse)
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oscar Benavente, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Robert Hart, M.D.

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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University of Southern Alabama Stroke Center

Mobile, Alabama, United States

Site Status

Catholic Healthcare West

Phoenix, Arizona, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

University of Arizona, Department of Neurology

Tucson, Arizona, United States

Site Status

University of California San Diego Medical Center

San Diego, California, United States

Site Status

University of California San Francisco-Fresno

San Francisco-Fresno, California, United States

Site Status

Denver

Englewood, Colorado, United States

Site Status

Melbourne

Melbourne, Florida, United States

Site Status

Miami-University of Miami, Miller School of Medicine

Miami, Florida, United States

Site Status

Emory University, Grady Health System

Atlanta, Georgia, United States

Site Status

Mercy Medical Center-Ruan Neurology Clinical Research

Des Moines, Iowa, United States

Site Status

University of Kentucky, Aging/Stroke Program

Lexington, Kentucky, United States

Site Status

Suburban Hospital

Bethesda, Maryland, United States

Site Status

Boston University

Boston, Massachusetts, United States

Site Status

Wayne State

Detroit, Michigan, United States

Site Status

Henry Ford Hospital, Department of Neurology

Detroit, Michigan, United States

Site Status

Berman Center

Minneapolis, Minnesota, United States

Site Status

Mayo Stroke Center KA-SL-13

Rochester, Minnesota, United States

Site Status

University of Washington

Sant Louis, Missouri, United States

Site Status

Tenet Health, St. Louis University

St Louis, Missouri, United States

Site Status

St. John's Mercy

St Louis, Missouri, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Buffalo

Buffalo, New York, United States

Site Status

Helen Hayes Hospital

Haverstraw, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Rochester General Hospital

Rochester, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Wake Forest University, Sciences-Neurology

Winston-Salem, North Carolina, United States

Site Status

Case Western

Cleveland, Ohio, United States

Site Status

Metrohealth Medical Center

Cleveland, Ohio, United States

Site Status

Ohio State University, Division of Stroke

Columbus, Ohio, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

University of Texas Southwestern

Dallas, Texas, United States

Site Status

Scurlock Stroke Center

Houston, Texas, United States

Site Status

University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Marshfield Clinic, Department of Neurology

Marshfield, Wisconsin, United States

Site Status

Medical College of Wisconsin-Neurology

Milwaukee, Wisconsin, United States

Site Status

Calgary Health

Calgary, Alberta, Canada

Site Status

SPS3 Coordinating Center

Vancouver, British Columbia, Canada

Site Status

Halifax

Halifax, Nova Scotia, Canada

Site Status

Ottawa Hospital General Campus

Ottawa, Ontario, Canada

Site Status

Greenfield Park

Greenfield Park, Quebec, Canada

Site Status

McGill-Jewish General

Montreal, Quebec, Canada

Site Status

McGill-Montreal General

Montreal, Quebec, Canada

Site Status

CHA-Hospital de l'Enfant-Jesus

Québec, Quebec, Canada

Site Status

Hospital Clinico de la Universidad Católica de Chile

Santiago, , Chile

Site Status

Hospital Naval Almirante Nef, 'Subida Alessandri s/n, Hall A, Oficina 9

Viña del Mar, , Chile

Site Status

Hospital-Clinica Kennedy

Guayaquil, , Ecuador

Site Status

Hospital de La Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, Mexico

Site Status

Antiguo Hospital Civil de Guadalajara

Guadalajara, , Mexico

Site Status

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zuibrán

Mexico City, , Mexico

Site Status

Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

Mexico City, , Mexico

Site Status

Hospital Sabogal Essalud-Unidad de Investigacion

Bellavista-Callao, Lima, Peru

Site Status

Hosp. Universitario Germans Trias I Pujol

Badalona, , Spain

Site Status

Hospital Del Mar, Passeig Marítim 25-29

Barcelona, , Spain

Site Status

Hospital de la Santa Creu I Sant Pau, c/Sant Antoni Maria Claret, 167

Barcelona, , Spain

Site Status

Hospital del Sagrat Cor. Quinta de Salut I'Alianca, c/Viladomat 288

Barcelona, , Spain

Site Status

Hosp. Parc Tauli de Sabadell

Barcelona, , Spain

Site Status

Hosp. de Girona Dr. Josep Trueta

Girona, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Universidad de Santiago de Compostela, Facultad de Medicina y Odontologia

Santiago de Compostela, , Spain

Site Status

Countries

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United States Canada Chile Ecuador Mexico Peru Spain

References

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Goldstein ED, Liew SQR, Shu L, Yaghi S. The impact of pre-stroke aspirin exposure on radiographic appearance and disability outcomes: A post-hoc analysis of the SPS3 trial: Aspirin Use and Small Subcortical Stroke. J Stroke Cerebrovasc Dis. 2024 Mar;33(3):107566. doi: 10.1016/j.jstrokecerebrovasdis.2024.107566. Epub 2024 Jan 10.

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Anadani M, Turan TN, Yaghi S, Spiotta AM, Gory B, Sharma R, Sheth KN, de Havenon A. Change in Smoking Behavior and Outcome After Ischemic Stroke: Post-Hoc Analysis of the SPS3 Trial. Stroke. 2023 Apr;54(4):921-927. doi: 10.1161/STROKEAHA.121.038202. Epub 2023 Mar 6.

Reference Type DERIVED
PMID: 36876480 (View on PubMed)

Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.

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PMID: 36398903 (View on PubMed)

Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

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PMID: 35224730 (View on PubMed)

Shihab S, Boucher RE, Abraham N, Wei G, Beddhu S. Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Systolic Blood Pressure Lowering on the Risk of Stroke. Hypertension. 2022 Apr;79(4):785-793. doi: 10.1161/HYPERTENSIONAHA.121.18172. Epub 2022 Feb 4.

Reference Type DERIVED
PMID: 35114798 (View on PubMed)

Cukierman-Yaffe T, McClure LA, Risoli T, Bosch J, Sharma M, Gerstein HC, Benavente O. The Relationship Between Glucose Control and Cognitive Function in People With Diabetes After a Lacunar Stroke. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1521-e1528. doi: 10.1210/clinem/dgab022.

Reference Type DERIVED
PMID: 33481011 (View on PubMed)

Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.

Reference Type DERIVED
PMID: 32905623 (View on PubMed)

Blum MR, Scherzer R, Ikeme JC, Benavente OR, McClure LA, Peralta CA, Odden MC. Functional health and white matter hyperintensities as effect modifiers of blood pressure-lowering on cognitive function and vascular events in older Secondary Prevention of Small Subcortical Strokes trial participants. J Hypertens. 2020 Aug;38(8):1578-1585. doi: 10.1097/HJH.0000000000002440.

Reference Type DERIVED
PMID: 32371759 (View on PubMed)

Agarwal A, Cheung AK, Ma J, Cho M, Li M. Effect of Baseline Kidney Function on the Risk of Recurrent Stroke and on Effects of Intensive Blood Pressure Control in Patients With Previous Lacunar Stroke: A Post Hoc Analysis of the SPS3 Trial (Secondary Prevention of Small Subcortical Strokes). J Am Heart Assoc. 2019 Aug 20;8(16):e013098. doi: 10.1161/JAHA.119.013098. Epub 2019 Aug 19.

Reference Type DERIVED
PMID: 31423869 (View on PubMed)

Ikeme JC, Pergola PE, Scherzer R, Shlipak MG, Catanese L, McClure LA, Benavente OR, Peralta CA. Cerebral White Matter Hyperintensities, Kidney Function Decline, and Recurrent Stroke After Intensive Blood Pressure Lowering: Results From the Secondary Prevention of Small Subcortical Strokes ( SPS 3) Trial. J Am Heart Assoc. 2019 Feb 5;8(3):e010091. doi: 10.1161/JAHA.118.010091.

Reference Type DERIVED
PMID: 30686103 (View on PubMed)

Magvanjav O, McDonough CW, Gong Y, McClure LA, Talbert RL, Horenstein RB, Shuldiner AR, Benavente OR, Mitchell BD, Johnson JA; NINDS SiGN (Stroke Genetics Network). Pharmacogenetic Associations of beta1-Adrenergic Receptor Polymorphisms With Cardiovascular Outcomes in the SPS3 Trial (Secondary Prevention of Small Subcortical Strokes). Stroke. 2017 May;48(5):1337-1343. doi: 10.1161/STROKEAHA.116.015936. Epub 2017 Mar 28.

Reference Type DERIVED
PMID: 28351962 (View on PubMed)

Wilson LK, Pearce LA, Arauz A, Anderson DC, Tapia J, Bazan C, Benavente OR, Field TS; SPS3 Investigators. Morphological classification of penetrating artery pontine infarcts and association with risk factors and prognosis: The SPS3 trial. Int J Stroke. 2016 Jun;11(4):412-9. doi: 10.1177/1747493016637366. Epub 2016 Mar 8.

Reference Type DERIVED
PMID: 26956031 (View on PubMed)

Boehme AK, McClure LA, Zhang Y, Luna JM, Del Brutto OH, Benavente OR, Elkind MS. Inflammatory Markers and Outcomes After Lacunar Stroke: Levels of Inflammatory Markers in Treatment of Stroke Study. Stroke. 2016 Mar;47(3):659-67. doi: 10.1161/STROKEAHA.115.012166.

Reference Type DERIVED
PMID: 26888535 (View on PubMed)

Peralta CA, McClure LA, Scherzer R, Odden MC, White CL, Shlipak M, Benavente O, Pergola P. Effect of Intensive Versus Usual Blood Pressure Control on Kidney Function Among Individuals With Prior Lacunar Stroke: A Post Hoc Analysis of the Secondary Prevention of Small Subcortical Strokes (SPS3) Randomized Trial. Circulation. 2016 Feb 9;133(6):584-91. doi: 10.1161/CIRCULATIONAHA.115.019657. Epub 2016 Jan 13.

Reference Type DERIVED
PMID: 26762524 (View on PubMed)

Odden MC, McClure LA, Sawaya BP, White CL, Peralta CA, Field TS, Hart RG, Benavente OR, Pergola PE. Achieved Blood Pressure and Outcomes in the Secondary Prevention of Small Subcortical Strokes Trial. Hypertension. 2016 Jan;67(1):63-9. doi: 10.1161/HYPERTENSIONAHA.115.06480. Epub 2015 Nov 9.

Reference Type DERIVED
PMID: 26553236 (View on PubMed)

McDonough CW, McClure LA, Mitchell BD, Gong Y, Horenstein RB, Lewis JP, Field TS, Talbert RL, Benavente OR, Johnson JA, Shuldiner AR. CYP2C19 metabolizer status and clopidogrel efficacy in the Secondary Prevention of Small Subcortical Strokes (SPS3) study. J Am Heart Assoc. 2015 May 27;4(6):e001652. doi: 10.1161/JAHA.114.001652.

Reference Type DERIVED
PMID: 26019129 (View on PubMed)

Pearce LA, McClure LA, Anderson DC, Jacova C, Sharma M, Hart RG, Benavente OR; SPS3 Investigators. Effects of long-term blood pressure lowering and dual antiplatelet treatment on cognitive function in patients with recent lacunar stroke: a secondary analysis from the SPS3 randomised trial. Lancet Neurol. 2014 Dec;13(12):1177-85. doi: 10.1016/S1474-4422(14)70224-8. Epub 2014 Oct 23.

Reference Type DERIVED
PMID: 25453457 (View on PubMed)

Field TS, McClure LA, White CL, Pergola PE, Hart RG, Benavente OR, Hill MD; SPS3 Investigators. Should Blood Pressure Targets After Lacunar Stroke Vary by Body Size? The SPS3 Trial. Am J Hypertens. 2015 Jun;28(6):756-64. doi: 10.1093/ajh/hpu228. Epub 2014 Dec 1.

Reference Type DERIVED
PMID: 25452300 (View on PubMed)

Asdaghi N, Pearce LA, Nakajima M, Field TS, Bazan C, Cermeno F, McClure LA, Anderson DC, Hart RG, Benavente OR; SPS3 Investigators. Clinical correlates of infarct shape and volume in lacunar strokes: the Secondary Prevention of Small Subcortical Strokes trial. Stroke. 2014 Oct;45(10):2952-8. doi: 10.1161/STROKEAHA.114.005211. Epub 2014 Sep 4.

Reference Type DERIVED
PMID: 25190442 (View on PubMed)

Sharma M, Pearce LA, Benavente OR, Anderson DC, Connolly SJ, Palacio S, Coffey CS, Hart RG. Predictors of mortality in patients with lacunar stroke in the secondary prevention of small subcortical strokes trial. Stroke. 2014 Oct;45(10):2989-94. doi: 10.1161/STROKEAHA.114.005789. Epub 2014 Aug 26.

Reference Type DERIVED
PMID: 25158772 (View on PubMed)

Palacio S, McClure LA, Benavente OR, Bazan C 3rd, Pergola P, Hart RG. Lacunar strokes in patients with diabetes mellitus: risk factors, infarct location, and prognosis: the secondary prevention of small subcortical strokes study. Stroke. 2014 Sep;45(9):2689-94. doi: 10.1161/STROKEAHA.114.005018. Epub 2014 Jul 17.

Reference Type DERIVED
PMID: 25034716 (View on PubMed)

Benavente OR, Pearce LA, Bazan C, Roldan AM, Catanese L, Bhat Livezey VM, Vidal-Pergola G, McClure LA, Hart RG; SPS3 Investigators. Clinical-MRI correlations in a multiethnic cohort with recent lacunar stroke: the SPS3 trial. Int J Stroke. 2014 Dec;9(8):1057-64. doi: 10.1111/ijs.12282. Epub 2014 May 27.

Reference Type DERIVED
PMID: 24862645 (View on PubMed)

Lewis BL, Pearce LA, Field TS, White CL, Benavente OR; SPS3 Investigators. The relevance of living supports on antiplatelet adherence and trial participation: the SPS3 trial. Int J Stroke. 2014 Jun;9(4):443-8. doi: 10.1111/ijs.12267. Epub 2014 Mar 24.

Reference Type DERIVED
PMID: 24661819 (View on PubMed)

Elkind MS, Luna JM, McClure LA, Zhang Y, Coffey CS, Roldan A, Del Brutto OH, Pretell EJ, Pettigrew LC, Meyer BC, Tapia J, White C, Benavente OR; LIMITS Investigators. C-reactive protein as a prognostic marker after lacunar stroke: levels of inflammatory markers in the treatment of stroke study. Stroke. 2014 Mar;45(3):707-16. doi: 10.1161/STROKEAHA.113.004562. Epub 2014 Feb 12.

Reference Type DERIVED
PMID: 24523037 (View on PubMed)

Dhamoon MS, McClure LA, White CL, Lau H, Benavente O, Elkind MS. Quality of life after lacunar stroke: the Secondary Prevention of Small Subcortical Strokes study. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):1131-7. doi: 10.1016/j.jstrokecerebrovasdis.2013.09.029. Epub 2013 Oct 28.

Reference Type DERIVED
PMID: 24177006 (View on PubMed)

White CL, Pergola PE, Szychowski JM, Talbert R, Cervantes-Arriaga A, Clark HD, Del Brutto OH, Godoy IE, Hill MD, Pelegri A, Sussman CR, Taylor AA, Valdivia J, Anderson DC, Conwit R, Benavente OR; SPS3 Investigators. Blood pressure after recent stroke: baseline findings from the secondary prevention of small subcortical strokes trial. Am J Hypertens. 2013 Sep;26(9):1114-22. doi: 10.1093/ajh/hpt076. Epub 2013 Jun 4.

Reference Type DERIVED
PMID: 23736109 (View on PubMed)

SPS3 Study Group; Benavente OR, Coffey CS, Conwit R, Hart RG, McClure LA, Pearce LA, Pergola PE, Szychowski JM. Blood-pressure targets in patients with recent lacunar stroke: the SPS3 randomised trial. Lancet. 2013 Aug 10;382(9891):507-15. doi: 10.1016/S0140-6736(13)60852-1. Epub 2013 May 29.

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PMID: 23726159 (View on PubMed)

Jacova C, Pearce LA, Costello R, McClure LA, Holliday SL, Hart RG, Benavente OR. Cognitive impairment in lacunar strokes: the SPS3 trial. Ann Neurol. 2012 Sep;72(3):351-62. doi: 10.1002/ana.23733.

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PMID: 23034910 (View on PubMed)

SPS3 Investigators; Benavente OR, Hart RG, McClure LA, Szychowski JM, Coffey CS, Pearce LA. Effects of clopidogrel added to aspirin in patients with recent lacunar stroke. N Engl J Med. 2012 Aug 30;367(9):817-25. doi: 10.1056/NEJMoa1204133.

Reference Type DERIVED
PMID: 22931315 (View on PubMed)

Palacio S, Hart RG, Pearce LA, Benavente OR. Effect of addition of clopidogrel to aspirin on mortality: systematic review of randomized trials. Stroke. 2012 Aug;43(8):2157-62. doi: 10.1161/STROKEAHA.112.656173.

Reference Type DERIVED
PMID: 22826359 (View on PubMed)

McClure LA, Szychowski JM, Benavente O, Coffey CS. Sample size re-estimation in an on-going NIH-sponsored clinical trial: the secondary prevention of small subcortical strokes experience. Contemp Clin Trials. 2012 Sep;33(5):1088-93. doi: 10.1016/j.cct.2012.06.007. Epub 2012 Jun 30.

Reference Type DERIVED
PMID: 22750086 (View on PubMed)

Graves JW, White CL, Szychowski JM, Pergola PE, Benavente OR, Coffey CS, Hornung LN, Hart RG; SPS3 Study Investigators. Predictors of lowering SBP to assigned targets at 12 months in the Secondary Prevention of Small Subcortical Strokes study. J Hypertens. 2012 Jun;30(6):1233-40. doi: 10.1097/HJH.0b013e328353968d.

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PMID: 22499292 (View on PubMed)

Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.

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PMID: 21899409 (View on PubMed)

Benavente OR, White CL, Pearce L, Pergola P, Roldan A, Benavente MF, Coffey C, McClure LA, Szychowski JM, Conwit R, Heberling PA, Howard G, Bazan C, Vidal-Pergola G, Talbert R, Hart RG; SPS3 Investigators. The Secondary Prevention of Small Subcortical Strokes (SPS3) study. Int J Stroke. 2011 Apr;6(2):164-75. doi: 10.1111/j.1747-4949.2010.00573.x. Epub 2011 Jan 26.

Reference Type DERIVED
PMID: 21371282 (View on PubMed)

Elkind MS, Luna JM, Coffey CS, McClure LA, Liu KM, Spitalnik S, Paik MC, Roldan A, White C, Hart R, Benavente O. The Levels of Inflammatory Markers in the Treatment of Stroke study (LIMITS): inflammatory biomarkers as risk predictors after lacunar stroke. Int J Stroke. 2010 Apr;5(2):117-25. doi: 10.1111/j.1747-4949.2010.00420.x.

Reference Type DERIVED
PMID: 20446946 (View on PubMed)

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Other Identifiers

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CRC

Identifier Type: -

Identifier Source: secondary_id

H09-03016

Identifier Type: -

Identifier Source: org_study_id

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