Policosanol + aspirin in post-stroke cognitive impairment

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

Poli/ASA-DC

Scientific title:

Effects of policosanol + aspirin therapy on cognitive impairment in patients with ischemic stroke.

Acronym of Scientific Title:

Poli/ASA-DC-IC

Secondary indentifying numbers:

Poli/ASA-DC01

Issuing authority of the secondary identifying numbers:

National Center for Scientific Research

Source(s) of monetary or material support:

National Center for Scientific Research, Central Account for BioCubafarma

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Javier

Midle name:

Vicente

Last name:

Sanchez Lopez

Medical Specialty :

Second Degree Specialist of Neurology and Intensive Care

Affiliation:

Institute of Neurology and Neurosurgery (INN)

Postal address:

D street No. 139 Corner 39, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-53256655

Email address:

javier.sanchez@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not Applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/09/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Ischemic stroke

Health condition(s) code:

Stroke

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Cardiovascular Diseases

Health condition keyword:

cerebral ictus

Intervention(s):

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 with breakfast, for 12 months. All patients will be instructed to consume 1 aspirin tablet (125 mg/day) orally daily, with breakfast, for 12 months.

Intervention code:

Hypolipidemic Agents

Aspirin

Placebos

Tablets

Administration, Oral

Intervention keyword:

Policosanol, PPG

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

60 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

4

Target sample size:

100

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Javier

Middle Name:

Vicente

Last Name:

Sanchez Lopez

Specialty:

Second Degree Specialist of Neurology and Intensive Care

Affiliation:

Institute of Neurology and Neurosurgery (INN)

Postal Address:

D Street No.139 Corner 39, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-53256655

Email :

javier.sanchez@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Clinical Trials Unit, National Center for Scientific Research

Postal Address:

25 Avenue and 158, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Institute of Neurology and Neurosurgery

Status of evaluation:

In review

Status of evaluation date of Ethic Committee:

15/05/2021

Postal address of Ethic Committee :

D street 139 corner 39, Plaza de La Revolucion, Havana, ZC 10400, Cuba

Telephone:

+53-78383022

Correo electrónico:

dirinn@inn.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/03/2023

Date of available results:

01/05/2023

Date of first publication:

01/07/2023

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000378

Date of Registration in Primary Registry:

30/06/2021

Record Verification Date:

2021/08/31

Next update date:

2022/08/31

Link to the spanish version:

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Policosanol + aspirin in post-stroke cognitive impairment

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