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Home > "S" Clinical Trials Conditions > Secondary Prevention of Small Subcortical Strokes (SPS3) Trial  Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
For Condition: Hypertension,Cerebrovascular Accident
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: The goal of this study is to learn if combination antiplatelet therapy (aspirin and clopidogrel) is more effective than aspirin alone for prevention of recurrent stroke and reduction in cognition, and if intensive blood pressure control is associated with fewer recurrent strokes and reduction in cognition.
Details: 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 together is more effective than using aspirin alone to prevent recurrent stroke in patients with lacunar stroke, 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 with hypertension will be randomly 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 or cause further damage.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 40 Years/
Genders: Both
Protocol Entry 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 following lacunar stroke clinical syndromes (adapted from Fisher) lasting > 24 hrs: a.Pure motor hemiparesis (PMH) b.Pure sensory stroke c.Sensorimotor stroke d.Ataxic hemiparesis e.Dysarthria-clumsy hand syndrome f.Hemiballism g.PMH with facial sparing h.PMH with horizontal gaze palsy i.PMH with contralateral III palsy j.PMH with contralateral VI palsy k.Cerebellar ataxia with contralateral III palsy - Pure dysarthria - 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 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. - MRI evidence of S3, specifically A and B: a.Presence of an S3 (1.5 cm in diameter) corresponding to the qualifying event (required for all brainstem events) OR multiple S3s 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 ³4) - 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: serum creatinine >2.0 mg/dl and GFR > 60 - 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)
Total Enrollment: 2500
Location and Contact Information:
Overall Study Official:
RobertHart, Principal Investigator, University of Texas
University of Texas Health Science Center *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Oscar Benavente 210-592-0404
Additional Information:
Study ID Numbers: R01NS38529;
Study Start Date: March 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059306
Other Cerebrovascular Accident Studies:
1. Potential Risk Factors for Stroke
2. Framingham Cycle V Offspring-Spouse Nutrition Studies
3. Framingham Nutrition Studies
4. Adherence to Antihypertensive Therapy--Data Analyses
5. Treatment of Hypertension with Two Exercise Intensities
Related Studies:
Other Cerebrovascular Accident Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Secondary Prevention of Small Subcortical Strokes (SPS3) Trial
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