None listed
Conditions
Interventions
BRAZO 2 Type of group
This group will be treated with Aspirin 325 mg PO QD until the clinical trial is completed. Clopidogrel Placebo PO QD until the clinical trial is completed. In addition, individuals may be assigned to a control of usual BP (130-149 mm Hg) or aggressive (
This group will be treated with Aspirin 325 mg PO QD until the clinical trial is completed. Clopidogrel 75 mg PO QD until the clinical trial ends. In addition, individuals may be assigned to a control of usual BP (130-149 mm Hg) or aggressive (
Sponsors
FUNDACION CAYETANO HEREDIA,
Eligibility
Age
38 Years to 86 Years
Inclusion criteria
Inclusion criteria: 1. One of the lacunary syndromes adapted by Fisher and lasting more than 24 hours. 2. Absence of signs of cortical dysfunction. 3. If the S3 is hemispherical, there should not be ipsilateral carotid stenosis> 50%. 4. Patients with high-risk cardioembolic sources requiring anticoagulation will not be included. 5. Evidence of: A) S3 in MRI B) Absence of cortical ACV and extensive subcortical ACV (> 1.5 cm), both recent and remote.
Exclusion criteria
Exclusion criteria: 1- Disabling ACV. 2- Previous intracranial hemorrhage or hemorrhagic stroke. 3- Age under 40 years. 4- Patients with a high risk of bleeding. 5- Patients possibly requiring anticoagulant treatment or with other antiplatelet agents in the future. 6- Previous cortical ACV. 7- Previous ipsilateral carotid endarterectomy. 8- Alteration in renal function. 9- Intolerance or contraindication to the use of aspirin or clopidogrel. 10-A score <24 in the Minimental of Folstein. 11-Medical contraindication for the realization of the RNM. 12-Pregnancy or women of childbearing age who do not follow effective contraceptive treatment. 13-Social or geographical factors that make it difficult to participate in the study. 14-Patients incapacitated or who do not want to sign the consent of the study. 15-Patients who do not comply with the treatment or who want to return to frequent controls. 16-Simultaneous participation with other research protocols. 17-Other possible mechanisms of stroke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. CT or brain MRI. Measure:Occurrence of stroke of any kind during follow-up. Timepoints:Clinical evaluation and radiological evaluation will be performed at the time of severe cognitive deterioration during the study. In addition, the MRI will be repeated 3 to 6 months after randomization if the initial MRI measures the lesion between 1.5-2 cm on its major axis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Applying the CASI score, obtaining a decrease of 10 points and maintaining this score for 1 month. CT or brain MRI: No evidence of new stroke. Measure:Secondary cognitive impairment. Timepoints:Clinical evaluation and radiological evaluation will be performed at the time of severe cognitive deterioration during the study. The CASI score will only be applied if an episode of secondary cognitive impairment occurs. ; Outcome name:Report of adverse events. Laboratory tests: Complete cytology, uremia, creatine, electrolytes, RIN, fasting lipid profile and Hemoglobin A1C (only in diabetics). Measure:Security. Timepoints:Report of adverse events: At the time of presentation. Complete cytology, uremia, electrolytes, RIN, fasting lipid profile: At the beginning of the study and according to clinical criteria Creatine and Hemoglobin A1C: Annually in diabetic patients. | — |
Countries
Argentina, Canada, Chile, Ecuador, Mexico, Peru, Spain, United States
Outcome results
None listed