Policosanol + aspirin in post-stroke cognitive impairment

Phase 4

• Conditions: Ischemic stroke; cerebral ictus; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

• Registration Number: RPCEC00000378
• Lead Sponsor: ational Center for Scientific Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study Completion: 2023-05-01
• Results First Posted: 2023-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Patients of both sexes,
2) Patients older or equal than 60 years of age.
3) Documented history of having suffered an ischemic stroke (diagnosed in the previous 30 days),
4) Who do not present evidence of cognitive decline (according to the questionnaire to be applied on the cognitive state of the patient),
5) With Rankin Scale values greater or equal than 2, less or equal than 5 (2-5),
6) Who agree to participate in the study by signing the informed consent.

Exclusion Criteria

Patients with:
1) Diagnosed neoplasms,
2) Atrial fibrillation,
3) Diastolic hypertension 110 mm Hg,
4) History of hemorrhagic stroke or subarachnoid hemorrhage,
5) Heart valves,
6) History of myocardial infarction, unstable angina, or revascularization in the previous 6 months,
7) Any other special condition that, in the opinion of the doctor, puts your health and life at risk during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant reduction of the score with respect to the baseline and the control group (Rankin scale). Measurement time: Baseline, 1.5, 3, 4.5, 6, 8, 10 and 12 months of treatment.<br>Significant improvement in the evolution of post-stroke cognitive impairment with respect to the onset and the control group (Cognitive Impairment Scale) Measurement time: Baseline, 1.5, 3, 4.5, 6, 8, 10 and 12 months of treatment.<br>

Secondary Outcome Measures

Name	Time	Method
Significant reduction of the score with respect to the start and the control group (Barthel Scale) Measurement time: Baseline, 1.5, 3, 4.5, 6, 8, 10 and 12 months of treatment.<br>Significant reduction in the LDL-C (mmol/L) values with respect to baseline and control group. Measurement time: Start, 3, 6 and 12 months of treatment.<br>Significant reduction in the Total cholesterol (mmol/L) values with respect to the baseline and the control group. Measurement time: Baseline, 3, 6 and 12 months of treatment.<br>Significant increase in the HDL-C (mmol/L) values with respect to baseline and control group. Measurement time: Baseline, 3, 6 and 12 months of treatment.<br>