Secondary Prevention of Small Subcortical Vascular Brain Attacks

Not Applicable

• Conditions: -I639 Cerebral infarction, unspecified; Cerebral infarction, unspecified; I639

• Registration Number: PER-076-05
• Lead Sponsor: FUNDACION CAYETANO HEREDIA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-07
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 186

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation.<br>CT or brain MRI.<br>Measure:Occurrence of stroke of any kind during follow-up.<br><br>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.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation: Applying the CASI score, obtaining a decrease of 10 points and maintaining this score for 1 month.<br>CT or brain MRI: No evidence of new stroke.<br><br>Measure:Secondary cognitive impairment.<br><br>Timepoints:Clinical evaluation and radiological evaluation will be performed at the time of severe cognitive deterioration during the study.<br>The CASI score will only be applied if an episode of secondary cognitive impairment occurs.<br>;<br>Outcome name:Report of adverse events.<br>Laboratory tests: Complete cytology, uremia, creatine, electrolytes, RIN, fasting lipid profile and Hemoglobin A1C (only in diabetics).<br>Measure:Security.<br>Timepoints:Report of adverse events: At the time of presentation.<br>Complete cytology, uremia, electrolytes, RIN, fasting lipid profile: At the beginning of the study and according to clinical criteria<br>Creatine and Hemoglobin A1C: Annually in diabetic patients.<br>