Policosanol in patients with metabolic syndrome and ischaemic cardiopaty

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-SM-CI

Scientific title:

Median term study of the effects of Policosanol in patients with metabolic syndrome and ischaemic cardiopathy

Acronym of Scientific Title:

Poli/Pla-SM-CI

Secondary indentifying numbers:

Poli/Pla-SM

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 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:

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:

Julian

Last name:

Chaviano Pereira

Medical Specialty :

First Degree Specialist in Internal Medicine

Affiliation:

"Luis Diaz Soto" Military Hospital

Postal address:

Monumental Street Km 2 1/2, East Havana

City:

Havana

Country:

Cuba

Zip Code:

11700

Telephone:

+53-77680094

Email address:

navaldocencia@infomed.sld.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:

"Luis Diaz Soto" Military Hospital, May 19th, 2016

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/01/2017

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:

Metabolic Syndrome and ischaemic cardiopaty

Health condition(s) code:

Metabolic Syndrome X

Myocardial Ischemia

Oxidative Stress

Insulin Resistance

Hyperinsulinism

Glucose Metabolism Disorders

Metabolic Diseases

Nutritional and Metabolic Diseases

Heart Diseases

Vascular Diseases

Cardiovascular Diseases

Intervention(s):

Group 1 (Experimental): 1 tablet of policosanol (10 mg) by oral administration, one daily with food for 6 months. Group 2 (Control): 1 tablet of placebo by oral administration, once daily with food for 6 months.

Intervention code:

Anticholesteremic Agents

Hypolipidemic Agents

Platelet Aggregation Inhibitors

Antioxidants

Fatty Alcohols

Administration, Oral

Placebos

Tablets

Intervention keyword:

Policosanol

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):

Oxidative stress and antioxidant defenses determination: Concentration of Maolondialdehido (MDA) (uM). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of advances products of the oxidation of proteins (PAOP) (uM cloramine). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of total organoperoxides (OT) (uM). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of glutation (GSH) (mg L). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of superoxid dismutase (SOD) (U mL min). Measuring time: at baseline, 90 and 180 days of treatment. Concentration of catalase (CAT) (uM). Measuring time: at baseline, 90 and 180 days of treatment.

Key secondary outcomes:

Tryglicerides (mmol/L), HDL-C (mmol/L). Measuring time: at baseline, 90 and 180 days of treatment. Risk stratification by total score of Goldman Scale. Measuring time: At baseline, 90 and 180 days of treatment. Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment. Laboratory parameters: cholesterol (mmol/L), LDL-C (mmol/L), alcaline phosphatase /U/L), glucose (mmol/L), creatinine (umol/L), ALT (U/L), AST (U/L), total protein (g/L), albumin (g/L), uric acid (mmol/L), urea (mmol/L), apo A (g/L9, apo B (g/L). Measuring time: At baseline, 45, 90, 135 and 180 days of treatment. Adverse Events-AE (Description (AE name), intensity (mild, moderate, severe), causality (definitely related, probably related, possibly related, unrelated)). Measuring time: At the end of 45, 90, 135 and 180 days 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:

25 years

Maximum age:

70 years

Inclusion criteria:

1) Patients with ischaemic cardiopaty. 2) Both sexes. 3) Age: 25-70 years 4) Diagnostic of metabolic syndrome by NCEP-ATP III criteria

Exclusion criteria:

1) Consuming policosanol or other lipid lowering drug and antioxidant or pro-oxidant medications, six months period previus study. 2) Ischaemic or haemorragic ictus. 3) Mayor surgery six mionths previusat study begining. 4) Cardiac insuficience. 5) Hepatic insuficience. 6) Neoplasms diagnosed. 7) Alcoholism. 8) Psyquiatric problems. 9) Patients with clinical history of allergy to any other medicines or other conditions that endanger 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:

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:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Center of Natural Products, National Center for Scientific Research

Postal Address:

198 street between 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+5372085834

Email :

julio.fernandez@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:

Sarahi

Last Name:

Mendoza Castaño

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Center of Natural products, National Centerfor Scientific Research

Postal Address:

198 street between 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+5372711654

Email :

sarahi.mendoza@cnic.edu.cu [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).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000227

Date of Registration in Primary Registry:

27/12/2016

Record Verification Date:

2016/12/27

Next update date:

2017/12/27

Link to the spanish version:

Click here [4]