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Policosanol + aspirin in post-stroke cognitive impairment

Effects of policosanol + aspirin therapy on cognitive impairment in patients with ischemic stroke. - Poli/ASA-DC-IC

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000378
Enrollment
100
Registered
2021-06-30
Start date
2021-09-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke cerebral ictus

Interventions

Experimental Group 1, Policosanol (20 mg/d): 2 tablets (10 mg) taken orally once a day with breakfast, for 12 months. Control Group 2, Placebo: 2 placebo tablets, which will be ingested orally once wi
Aspirin
Placebos
Tablets
Administration, Oral
Policosanol, PPG

Sponsors

National Center for Scientific Research
Lead Sponsor
OSDE BioCubaFarma
Collaborator

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. 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.

Secondary

MeasureTime frame
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. 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. 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. 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.

Countries

Cuba

Contacts

Public ContactJavier Sanchez Lopez

Institute of Neurology and Neurosurgery (INN)

javier.sanchez@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026