Policosanol in Coronary Artery Disease

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 in patients with coronary artery disease.

Secondary indentifying numbers:

Poli/P-EC2

Issuing authority of the secondary identifying numbers:

National Centre for Scientific Research (CNIC)

Source(s) of monetary or material support:

OSDE 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:

Leandro

Last name:

Martinez Navarro

Medical Specialty :

First degree specialist in Cardiology

Affiliation:

10 de Octubre Clinical Surgical Teaching Hospital

Postal address:

Calzada 10 de Octubre No. 130 / Alejandro Ramirez y Agua Dulce, Cerro

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-5359927671

Email address:

leandro.martinez@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:

30/03/2026

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:

Coronary artery disease

Intervention(s):

Group 1, Policosanol (20 mg/day) (Experimental): 1 policosanol tablet (20 mg) + 1 placebo tablet + 1 aspi-rin tablet (81 mg), by oral route, with breakfast for 12 months. Group 2, Policosanol (40 mg/day) (Experimental): 2 policosanol tablets (20 mg) + 1 aspirin tablet (81 mg), by oral route, with breakfast for 12 months. Group 3, Placebo (Control): 2 placebo tablets + 1 aspirin tablet (81 mg), by oral route, with breakfast for 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):

1. Platelet aggregation compared (values of arachidonic acid (mmol/L), collagen (ug/mL), ADP (mmol/L). Measurement time: At baseline, and at 3, 6, 9 and 12 months of treatment. 2. Values of LDL-C , Total cholesterol, and HDL-C (values expressed in mmol/L). Measurement time: At baseline and at 3, 6, 9 and 12 months of treatment. Measurement time: At baseline, and at 3, 6, 9 and 12 months of treatment.

Key secondary outcomes:

Carotid intima-media thickness (value in mm measured using a carotid ultrasound). Measurement time: At baseline, and at 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:

18 years

Maximum age:

None

Inclusion criteria:

Patients of both sexes ≥ 18 years with ischemic heart disease, unstable angina or acute coronary syndrome (myocardial infarction without or with ST segment elevation).

Exclusion criteria:

1. Patients under 18 years of age with ischemic heart disease, arrhythmias with hemodynam-ic compromise, or heart failure of valvular origin. 2. Patients with stents. 3. Patients with electrocardiographic images of chronic myocardial ischemia. 4. Patients with a prior history of stroke (ischemic or hemorrhagic), or peripheral arterial dis-ease diagnosed as intermittent claudication. 5. Diagnosed neoplasms. 6. Use of medications that could affect platelet aggregation (clopidogrel) and/or the lipid pro-file (statins). A7. llergy to any component of the study medication or any other special medical condition that, in the physician's judgment, may endanger the patient's health and life during the study, taking into account the expected effects of the treatment and the patient's clinical condition at that time.

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:

150

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:

Leando

Last Name:

Martinez Navarro

Specialty:

First degree specialist in Cardiology

Affiliation:

10 de octubre Clinical Sugical Teaching Hospital

Postal Address:

Calzada 10 de Octubre No. 130 / Alejandro Ramirez y Agua Dulce, Cerro

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-59927671

Email :

leandro.martinez@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:

National Centre for Scientific Research (CNIC)

Postal Address:

25 Avenue and 158 st, Cubanacan, Playa

City:

Havana

Country:

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:

10 de octubre Clinical Sugical Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

19/12/2025

Postal address of Ethic Committee :

Calzada 10 de Octubre No. 130 e/Alejandro Ramirez y Agua Dulce. Cerro. ZC:10300, Havana, Cuba

Telephone:

+53-78252292

Email:

manuel.hernandez@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

29/06/2027

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:

RPCEC00000470

Date of Registration in Primary Registry:

18/02/2026

Record Verification Date:

2026/02/18

Next update date:

2027/02/18

Link to the spanish version:

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Policosanol in Coronary Artery Disease

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