|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| 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.
|
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 |
INCLUSION:
Inclusion criteria are based on TOAST criteria supplemented by required MRI data. All of the following criteria must be met:
EXCLUSION:
To be eligible for entry into the study, the patient must not meet any of the criteria listed below:
Contacts and Locations| Contact: Oscar Benavente, M.D. | (210) 592-0404 | benavente@uthscasa.edu |
Hide Study 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 | |
| Principal Investigator: | Oscar Benavente, M.D. | University of Texas |
| Principal Investigator: | Robert Hart, M.D. | University of Texas |
More Information
| 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 |
|
stroke hypertension high blood pressure lacunar stroke |
subcortical stroke aspirin clopidogrel |
|
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 |