Policosanol for long term-Ictus

Effects of long term treatment of policosanol plus aspirin in patients with ischaemic stroke

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000169

Enrollment

Registered

2013-09-13

Start date

2011-12-27

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

ischaemic stroke

Interventions

Control Group: Placebo of Policosanol - 2 daily tablets by oral route during 12 months + Aspirin- 1 daily tablet (125 mg) by oral route during 12 months Study Group: Policosanol - 2 daily tablets (10

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Documented history of TIA or stroke in the previous 3 months (diagnosed in 30 days) 2. Who agree to participate 3. Rankin scale values ??of 2 to 5 4. No exclusion criteria

Exclusion criteria

Exclusion criteria: 1. Neoplasms diagnosed 2. Atrial fibrillation 3. Hipertenmsión diastolic <= 110 mm Hg 4. History of hemorrhagic stroke or subarachnoid hemorrhage 5. Heart Valves 6. IMA background, unstable angina or revasculariación in 6 months 7. Any special condition to the doctor that jeopardize their health and their lives during the study

Design outcomes

Primary

Measure	Time frame
Neurological deficit (Modified Rankin Scale. 0-No symptoms, 1-symptoms but able to perform all usual activities, 2-mild disability but able to carry out activities without assistance, 3-moderate disability requiring some help but able to walk unassisted, 4-moderately severe disability, 5 severe disability, bedridden, incontinent, and requires nursing care and constant attention). Measuring time: at baseline, at 6,12,18, 24,32, 40 and 48 weeks.	—

Measure

Time frame

Neurological deficit (Modified Rankin Scale. 0-No symptoms, 1-symptoms but able to perform all usual activities, 2-mild disability but able to carry out activities without assistance, 3-moderate disability requiring some help but able to walk unassisted, 4-moderately severe disability, 5 severe disability, bedridden, incontinent, and requires nursing care and constant attention). Measuring time: at baseline, at 6,12,18, 24,32, 40 and 48 weeks.

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Secondary

Measure	Time frame
Neurological deficit (Barthel scale. <45 - severe, Grave 45-59, 60-80 Moderate light 80-100). Measuring time: at baseline, at 6,12,18, 24,32, 40 and 48 weeks. Blood biochemical parameters (Total cholesterol (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L), ALT (U/L), AST(U/L), Glucosa (mmol/L), creatinina (umol/L), GGT (U/L)). Measuring time: at baseline, at 12, 24 and 48 weeks. Physical Assessment (Body weight (kg), frequency (beats / min), blood pressure (mm Hg)). Measuring time: at baseline, at 6, 12, 18, ??24, 32, 40 and 48 weeks. Adverse events (description (name of the event), intensity (mild-moderate, severe), causality (definitely related, probably related, possibly related, not related)).Measuring time: at baseline, at 6, 12, 18, ??24, 32, 40 and 48 weeks.	—

Measure

Time frame

Neurological deficit (Barthel scale. <45 - severe, Grave 45-59, 60-80 Moderate light 80-100). Measuring time: at baseline, at 6,12,18, 24,32, 40 and 48 weeks. Blood biochemical parameters (Total cholesterol (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L), ALT (U/L), AST(U/L), Glucosa (mmol/L), creatinina (umol/L), GGT (U/L)). Measuring time: at baseline, at 12, 24 and 48 weeks. Physical Assessment (Body weight (kg), frequency (beats / min), blood pressure (mm Hg)). Measuring time: at baseline, at 6, 12, 18, ??24, 32, 40 and 48 weeks. Adverse events (description (name of the event), intensity (mild-moderate, severe), causality (definitely related, probably related, possibly related, not related)).Measuring time: at baseline, at 6, 12, 18, ??24, 32, 40 and 48 weeks.

—

Countries

Cuba

Contacts

Public ContactSarahi Mendoza Castaño

Center of Natural Products/ National Center for Scientific Researchs

sarahi.mendoza@cnic.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026