Policosanol for long term-Ictus

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.

Scientific title:

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

Secondary indentifying numbers:

D-00103LPII

Issuing authority of the secondary identifying numbers:

Center of Natural Products/National Center for Scientific Researchs

Source(s) of monetary or material support:

National Center for Scientific Researchs BIOCUBAFARMA (Central Account)

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

José

Last name:

Illnait Ferrer

Medical Specialty :

Specialist of 2nd degree on Clinical Biochemistry

Affiliation:

CIMEQ Hospital

Postal address:

216 st and 11B, Siboney, Playa

City:

havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085834

Email address:

jose.illnait@cnic.edu.cu [1]

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

Research ethics committees:

CIMEQ, 20/12/2011

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

27/12/2011

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:

ischaemic stroke

Intervention(s):

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 mg) by oral route during 12 months + Aspirin- 1 daily tablet (125 mg) by oral route during 12 months

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):

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.

Key secondary outcomes:

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.

Selection criterias

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

Gender:

Male/Female

Minimum age:

20 years

Maximum age:

None

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:

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

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:

Target sample size:

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:

Sarahi

Last Name:

Mendoza Castaño

Specialty:

Pharmaceutical Sciences, PhD

Affiliation:

Center of Natural Products/ National Center for Scientific Researchs

Postal Address:

198 / 19 y 21, Atabey, Playa

City:

havana

País:

Cuba

Zip Code:

11300

Telephone:

+537 2714225/2714238/2714200

Email :

sarahi.mendoza@cnic.edu.cu [2]

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:

Rosa

Last Name:

Mas Ferreiro

Specialty:

Biological Science, PhD

Affiliation:

Center of Natural Products/National Center for Scientific Researchs

Postal Address:

198/19 and 21, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+537 2731522

Email :

email@not.entered [3]

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).

Unique ID number:

RPCEC00000169

Date of Registration in Primary Registry:

13/09/2013

Record Verification Date:

2013/09/13

Next update date:

2014/09/13

Link to the spanish version:

Click here [4]