Policosanol-Atorvastatina for 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 policosanol and atorvastatin on ischemic stroke recovery

Secondary indentifying numbers:

Poli- Atorva 012

Issuing authority of the secondary identifying numbers:

Center of Natural Products/National Center for Scientific Research

Source(s) of monetary or material support:

National Center for Scientific Research 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 :

2nd degree on clinical biochemistry

Affiliation:

Surgical Medical Research Center

Postal address:

216 and 11-B, Siboney, Playa

City:

Havana City

Country:

Cuba

Zip Code:

11300

Telephone:

+53-78581000

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:

Surgical Medical Research Center, April 11, 2013

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

02/09/2013

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

Intervention(s):

Study Group. Policosanol (20 mg). One tablet daily during 3 months, Aspirin (125 mg). One tablet daily during 3 months. Control Group. Atorvastatin (20 mg). One tablet daily during 3 months, Aspirin (125 mg). One tablet daily during 3 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 slight disability but able to carry out activities without assistance, 3 moderate disability, requiring some help, but able to walk without assistance, 4 moderately severe disability, 5 = severe disability: bedridden, incontinent, and requires nursing care and constant attention). Measuring time: baseline and after 4, 8 and 12 weeks on treatment.

Key secondary outcomes:

Blood biochemical parameters Total cholesterol (mmol / L) , Triglycerides (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L)). Measuring time: at baseline and 6 months. PSA test (PSA, ng/mL). Measuring time: at baseline and 6 months.

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:

The sample will be comprised 1.Patients of both sexes 2. Age ≥ 20 years 3. documented history of previous (3 months) TIA or ischemic stroke (diagnosed within 30 days of its appearance) 4. who agree to participate in the study 5. With neurological deficit of Rankin Scale 2 -5 6. Without exclusion criteria.

Exclusion criteria:

1. Neoplasms diagnosed 2. atrial fibrillation 3. diastolic hypertension 4. history of hemorrhagic stroke or subarachnoid hemorrhage 5. documented evidence of cerebral aneruisma, history of myocardial infarction, unstable angina or revascularization in the 6 months prior the study 6. any other special conditions threatening 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:

Active

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 Research

Postal Address:

198 / 19 and 21, Atabey, Playa

City:

Havana City

Country:

Cuba

Zip Code:

11300

Telephone:

(537) 2714225

Email :

sarahi.mendoza@cnic.edu.cu [1]

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:

Dra. Rosa

Last Name:

Mas Ferreiro

Specialty:

Biological Science, PhD

Affiliation:

Center of Natural Products, National Center for Scientific Research

Postal Address:

198 / 19 and 21, Atabey, Playa

City:

Havana City

Country:

Cuba

Zip Code:

11300

Telephone:

(537)2731522

Email :

clinica@cnic.edu.cu [2]

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:

RPCEC00000167

Date of Registration in Primary Registry:

02/09/2013

Record Verification Date:

2013/09/02

Next update date:

2014/09/02

Link to the spanish version:

Click here [3]