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Secondary Prevention of Small Subcortical Strokes Trial (SPS3)
This study is currently recruiting participants.
Verified by The University of Texas Health Science Center at San Antonio, November 2008
First Received: April 23, 2003   Last Updated: July 23, 2009   History of Changes
Sponsor: The University of Texas Health Science Center at San Antonio
Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00059306
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Hypertension
Drug: aspirin
Drug: clopidogrel
Other: Target of Blood Pressure
Other: placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title: Secondary Prevention of Small Subcortical Strokes (SPS3) Trial

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI [ Time Frame: Mean follow up of 3 years ] [ Designated as safety issue: Yes ]
  • Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. [ Time Frame: within mean follow-up of 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The difference in the rate of cognitive decline among SPS3 participants assigned to received aspirin alone versus combination of aspirin and clopidogrel, assessed through repeated neuropsychological tests. [ Time Frame: within mean follow-up of 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: February 2003
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Antiplatelet: Active Comparator
Participants receive aspirin + placebo OR aspirin + clopidogrel
Drug: 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.
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.
Other: placebo
an inactive substance
Blood pressure: Active Comparator
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.
Other: 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.

Detailed Description:

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 2500 participants (20 percent of whom will be Hispanic Americans) 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION:

Inclusion criteria are based on TOAST criteria supplemented by required MRI data. All of the following criteria must be met:

  • 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 <4)
  • Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
  • Age under 40 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059306

Contacts
Contact: Oscar Benavente, M.D. (210) 592-0404 benavente@uthscasa.edu

  Hide Study Locations
Locations
United States, Alabama
University of Southern Alabama Stroke Center Recruiting
Mobile, Alabama, United States, 36617
Contact: Mel Parnell, RN     251-660-5518     mparnell@usouthal.edu    
United States, Arizona
University of Arizona, Department of Neurology Recruiting
Tucson, Arizona, United States, 85724
Contact: Mina Malekniazi     520-626-4150     malekniazi@peds.arizona.edu    
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Judy Wieser     480-301-4604     wieser.judith@mayo.edu    
Catholic Healthcare West Recruiting
Phoenix, Arizona, United States, 85013
Contact: Carol Darbonne     602-406-6228     carol.darboone@chw.edu    
United States, California
Sutter Neuroscience Institute Recruiting
Sacramento, California, United States, 95816
Contact: Teresa Carter     916-454-6976     cartert2@sutterhealth.org    
University of California San Diego Medical Center Recruiting
San Diego, California, United States, 92103-8466
Contact: Nancy Kelly     858-657-7118     nkelly@ucsd.edu    
United States, Florida
Miami-University of Miami, Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Mary Lichtenberger     305-243-7526     mlichtenberger@med.miami.edu    
United States, Georgia
Emory University, Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Janet Braimah     404-616-8742     jbraima@emory.edu    
United States, Iowa
Mercy Medical Center-Ruan Neurology Clinical Research Recruiting
Des Moines, Iowa, United States, 50314
Contact: Theresa Hamm     515-358-0023     thamm@mercydesmoines.org    
United States, Kentucky
University of Kentucky, Aging/Stroke Program Recruiting
Lexington, Kentucky, United States, 40506-0230
Contact: Anna Fowler     859-257-5560     ahfowl2@email.uky.edu    
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02118
Contact: Helena Lau     617-414-1171     hlau@bu.edu    
United States, Michigan
Wayne State Recruiting
Detroit, Michigan, United States, 48201
Contact: Flicia Mada     313-745-1893     fmada@med.wayne.edu    
Henry Ford Hospital, Department of Neurology Recruiting
Detroit, Michigan, United States, 48202
Contact: Sharon McCarthy     313-916-2214     sharonm@neuro.hfh.edu    
United States, Minnesota
Berman Center Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Donna Brauer     612-347-4420     dbrauer@bermancenter.org    
Mayo Stroke Center KA-SL-13 Recruiting
Rochester, Minnesota, United States, 55905
Contact: Deb Herzig     507-284-1543     herzig.debra@mayo.edu    
United States, Missouri
Tenet Health, St. Louis University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Eve Holzemer     314-577-8738     eve.holzemer@tenethealth.com    
St. John's Mercy Recruiting
St. Louis, Missouri, United States, 63141
Contact: Sally Schroer     314-251-5913     schrs1@stlo.merchy.net    
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Patricia Niblack     856-968-7269     niblack-p@cooperhealth.org    
United States, New York
Helen Hayes Hospital Recruiting
Haverstraw, New York, United States, 10993
Contact: Laura Tenteromano     845-786-4854     tenteromanl@helenhayeshosp.org    
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Contact: Patricia Wallace     585-922-5683     pat.wallace@viahealth.org    
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Tania E Corporan     212-305-7755     tcorporan@neuro.columbia.edu    
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Justine Zentner     585-275-1204     justine_zentner@urmc.rochester.edu    
Contact: Ann Leonhardt, RN     585-273-2861     ann_leonhardt@urmc.rochester.edu    
United States, North Carolina
Wake Forest University, Sciences-Neurology Recruiting
Winston-Salem, North Carolina, United States, 27157-1078
Contact: Sara Thrower     336-716-8694     sathrowe@wfubmc.edu    
United States, Ohio
Metrohealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Dana Cook     216-778-5420     dcook@metrohealth.org    
Ohio State University, Division of Stroke Recruiting
Columbus, Ohio, United States, 43210
Contact: Julie Agriesti     614-293-4098     agriesti.11@osu.edu    
Case Western Recruiting
Cleveland, Ohio, United States, 44106
Contact: David Korosec     216-983-0796     david.korosec@uhhospitals.org    
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Megan Cingel     503-494-7191     cingelm@ohsu.edu    
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Diane Brown     615-936-0062     diane.klein@vanderbilt.edu    
United States, Texas
University of Texas Health Science Center Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Oscar Benavente, M.D.     210-592-0404     benavente@uthscasa.edu    
Principal Investigator: Oscar Benavente, M.D.            
SPS3 Coordinating Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Ana M Roldan, MS     210-592-0263     roldana@uthscsa.edu    
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390-8897
Contact: April Blair     214-648-0363     april.blair@utsouthwestern.edu    
Scurlock Stroke Center Recruiting
Houston, Texas, United States, 77030
Contact: Larry Katz     713-441-5803     lkatz@tmh.tmc.edu    
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104-2499
Contact: Patricia M Tanzi, RN, BSN     206-744-3938     ptanzi@u.washington.edu    
United States, Wisconsin
Medical College of Wisconsin-Neurology Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Stephanie Rozman     414-805-9226     srozman@mcw.edu    
Marshfield Clinic, Department of Neurology Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Kathleen Mancl     715-389-3748     manci.kathleen@mcrf.mfldclin.edu    
Argentina
Centro Neurológico de Tratamiento y Rehabilitación Recruiting
Buenos Aires, Argentina, C1126AAAE
Contact: Conrado J. Estol     5411-4811-1875     cjestol@infovia.com.ar    
Hospital Universitario Austral Recruiting
Buenos Aires, Argentina, 1629
Contact: Jose A Bueri     5423-2248-2838     jbueri@cas.austral.edu.ar    
Institute for Neurological Research, FLENI Recruiting
Buenos Aires, Argentina, 1428
Contact: Sebastin F. Ameriso     5411 5777 0120     sameriso@fleni.org.ar    
Hospital Britanico Recruiting
Buenos Aires, Argentina, 1280
Contact: Manuel Maria Fernandez Pardal     5411-4956-1081     mferpardal@hotmail.com    
Hospital Ramos Mejía División de Neurología Recruiting
Buenos Aires, Argentina, 1221
Contact: Raúl Carlos Rey     54-11-4127-0436     raulcrey@hotmail.com    
Canada, Alberta
Calgary Health Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Karyn Fischer     403-944-2370     karyn.fischer@calgaryhealthregion.ca    
Canada, Nova Scotia
Halifax Recruiting
Halifax, Nova Scotia, Canada, B3H 4V7
Contact: Yvette Reidy     902-473-2026     yreidy@dal.ca    
Canada, Ontario
Ottawa Hospital General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Jennifer Sauvé     613-737-8899 ext 7933     jesauve@ottawahospital.on.ca    
Canada, Quebec
McGill-Jewish General Recruiting
Montreal, Quebec, Canada, H37 1E2
Contact: Claudia Schanz     514-340-8222 ext 2544     cschanz@neu.jgh.mcgill.ca    
McGill-Montreal General Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Lisa Wadup     514-934-1934 ext 42522     lisa.wadup@muhc.mcgill.ca    
CHA-Hospital de l'Enfant-Jesus Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Annette Hache     418-649-5543     annette.hache.cha@sss.gouv.qc.ca    
Greenfield Park Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Denise Racicot     450-466-5000 ext 2462     denise.racicot@rrsss16.gouv.qu.ca    
Chile
Hospital Naval Almirante Nef, 'Subida Alessandri s/n, Hall A, Oficina 9 Recruiting
Viña del Mar, Chile, 2530116
Contact: Gonzalo A. Matamala, MD     56-322-573097     g.matamala@vtr.net    
Hospital Clinico de la Universidad Católica de Chile Recruiting
Santiago, Chile
Contact: Jorge Tapia     56-2-686-3316     jftapia@med.puc.cl    
Ecuador
Hospital-Clinica Kennedy Recruiting
Guayaquil, Ecuador
Contact: Oscar Del Brutto     593-4228-5790     odbp@gye.satnet.net    
Mexico
Antiguo Hospital Civil de Guadalajara Recruiting
Guadalajara, Mexico, 44280
Contact: Jose Luis Ruiz Sandoval     5233 3613 4016     jorulej-1nj@prodigy.net.mx    
Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez Recruiting
Mexico City, Mexico, 14269
Contact: Antonio Arauz     52-555-60 3822 ext 4466     arauzg@prodigy.net.mx    
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zuibrán Recruiting
Mexico City, Mexico, 14000
Contact: Carlos Cantú Brito     52-555-487-0900 ext 2523     carloscantu_brito@hotmail.com    
Mexico, Nuevo Leon
Hospital de La Universidad Autonoma de Nuevo Leon Recruiting
Monterrey, Nuevo Leon, Mexico, 644460
Contact: Fernando Gongora, MD     52-81-8333-7313     fernando.gongora@hotmail.com    
Peru, Lima
Hospital Sabogal Essalud-Unidad de Investigacion Recruiting
Bellavista-Callao, Lima, Peru
Contact: Edwin Javier Pretell Alva     511-328-4038     ejpretell@hotmail.com    
Spain
Hospital La Paz Recruiting
Madrid, Spain, 28046
Contact: Exuperio Diez-Tejedor, MD     34-91727-7444     ediezt@meditex.es    
Hospital de la Santa Creu I Sant Pau, c/Sant Antoni Maria Claret, 167 Recruiting
Barcelona, Spain, 08025
Contact: Sergio Martinez, MD     34-93291-9049     smartinezr@santpau.cat    
Hospital del Sagrat Cor. Quinta de Salut I'Alianca, c/Viladomat 288 Recruiting
Barcelona, Spain, 08029
Contact: Adria Arboix     34-93494-8940     aarboix@hscor.com    
Universidad de Santiago de Compostela, Facultad de Medicina y Odontologia Recruiting
Santiago de Compostela, Spain, 15782
Contact: Miguel Bianco Gonzalez     34-981-112049     miguel.blanco.gonzalez2@sergas.es    
Hosp. de Girona Dr. Josep Trueta Recruiting
Girona, Spain, 17007
Contact: Mar Castellanos     34-97294 0262     mcastellanosr@medynet.com    
Hosp. Universitario Germans Trias I Pujol Recruiting
Badalona, Spain, 08916
Contact: Meritxel Gomis Cortina     34 93497 8911     mgromis@imas.imim.es    
Hosp. Parc Tauli de Sabadell Recruiting
Barcelona, Spain, 08208
Contact: David Cánovas Vergé     34 93661 313356     dcanovas@cspt.es    
Hospital Del Mar, Passeig Marítim 25-29 Recruiting
Barcelona, Spain, 08003
Contact: Jaume Roquer González     34 93248 3235     35826@imas.imim.es    
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Oscar Benavente, M.D. University of Texas
Principal Investigator: Robert Hart, M.D. University of Texas
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Health Science Center at San Antonio, School of Medicine ( Oscar Benavente, MD, Associate Professor and SPS3 Principal Investigator )
Study ID Numbers: R01NS38529, CRC
Study First Received: April 23, 2003
Last Updated: July 23, 2009
ClinicalTrials.gov Identifier: NCT00059306     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
stroke
hypertension
high blood pressure
lacunar stroke
subcortical stroke
aspirin
clopidogrel

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Cerebrovascular Disorders
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Clopidogrel
Platelet Aggregation Inhibitors
Brain Infarction
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009