Can we prevent immune cell ageing in patients with Coronary Heart Disease?

Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome: a double-blind, phase II, pilot randomised controlled trial (TACTIC) - Telomerase activator TA-65MD® in patients with ACS (TACTIC)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002876-26-GB

Enrollment

Registered

2017-10-25

Start date

2018-10-19

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosenescence in patients who have had an acute coronary syndrome diagnosed within the last 6 months. MedDRA version: 20.1 Level: PT Classification code 10011968 Term: Decreased immune responsiveness System Organ Class: 10021428 - Immune system disorders

Interventions

Product Name: TA-65MD Pharmaceutical Form: Capsule INN or Proposed INN: Cycloastrogenol CAS Number: 78574-94-4 Other descriptive name: T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Able to give written informed consent • Patients aged 65 or over with an index presentation of an acute coronary syndrome* within the previous 6 months • Successfully completed revascularisation** or managed medically following ACS • Angiographic evidence of coronary heart disease (at least one major epicardial vessel stenosis =70%) • More than 24 hours after presentation with the index event *Acute coronary syndrome (ACS) defined as either a non ST elevation acute coronary syndrome (NSTEMI), or ST elevation MI (STEMI) only. **PCI/angioplasty (eligible the following day) or surgery (eligible 3 months later) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: • Patients with any disorder associated with immunological dysfunction (acute or chronic inflammatory or neoplastic co-existing disease, known positive serology for HIV, or hepatitis) • Clinically unstable patients (haemodynamically unstable, cardiogenic shock, unconscious) • Severe, uncontrolled hypertension (Blood Pressure >170/110mmHg, or ambulatory BP of 150/95mmHg); • Severe comorbidity that has an impact on outcome over next 2 years • Taking immunosuppressants • Known malignancy • Insulin-controlled diabetes • Judgment by the Investigator that the patient should not participate in the study, for example, if the patient is unlikely to comply with study procedures, restrictions, and requirements • Participation in any other interventional medicinal studies in the past 6 months

Design outcomes

Primary

Measure	Time frame
Main Objective: As people get older, the cells of their bodies lose the ability to renew and repair as well as they did when they were younger; this is known as cellular ageing. This leads to signs of ageing including the deterioration of organs such as the heart and a reduced ability of the immune system to fight infections and maintain overall health. One reason why cells age, is damage to the DNA that is contained inside them. DNA contains all of the information about how a cell will function, and can be thought of as a piece of string. At the ends of the DNA there are protective caps called telomeres that maintain the health of DNA. Cells need to divide in order to replace lost or dead cells, but during the process of dividing, some of the protective cap (telomeres) is lost and is not passed on to new cells. Therefore, throughout life, the length of the telomeres becomes shorter and this is linked to cell ageing and a decrease in cell health. There is a product called TA-65MD® that has been shown ; Secondary Objective: •This study will also investigate the effect of TA-65MD® on the small blood vessels that play an important role in the health of the heart. •We will investigate whether cytomegalovirus exposure in participants has an effect on the immune system or the heart •Investigate the effect of TA-65MD® on overall inflammation levels •Investigate the effect of TA-65MD® on heart strain/heart failure and how well the heart is functioning •Investigate the effect of TA-65MD® on length of telomeres , as the way that TA-65MD® works is by making telomeres longer, we want to check that the length of telomeres is increased in people who take TA-65MD®. •Investigate the effect of TA-65MD® on telomerase activity- as TA-65MD® is supposed to increase telomerase activity we want to check this •We will look at the rates of adherence to	—

Measure

Time frame

Main Objective: As people get older, the cells of their bodies lose the ability to renew and repair as well as they did when they were younger; this is known as cellular ageing. This leads to signs of ageing including the deterioration of organs such as the heart and a reduced ability of the immune system to fight infections and maintain overall health. One reason why cells age, is damage to the DNA that is contained inside them. DNA contains all of the information about how a cell will function, and can be thought of as a piece of string. At the ends of the DNA there are protective caps called telomeres that maintain the health of DNA. Cells need to divide in order to replace lost or dead cells, but during the process of dividing, some of the protective cap (telomeres) is lost and is not passed on to new cells. Therefore, throughout life, the length of the telomeres becomes shorter and this is linked to cell ageing and a decrease in cell health. There is a product called TA-65MD® that has been shown ; Secondary Objective: •This study will also investigate the effect of TA-65MD® on the small blood vessels that play an important role in the health of the heart. •We will investigate whether cytomegalovirus exposure in participants has an effect on the immune system or the heart •Investigate the effect of TA-65MD® on overall inflammation levels •Investigate the effect of TA-65MD® on heart strain/heart failure and how well the heart is functioning •Investigate the effect of TA-65MD® on length of telomeres , as the way that TA-65MD® works is by making telomeres longer, we want to check that the length of telomeres is increased in people who take TA-65MD®. •Investigate the effect of TA-65MD® on telomerase activity- as TA-65MD® is supposed to increase telomerase activity we want to check this •We will look at the rates of adherence to

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: baseline, 1, 3, 6, 9 and 12 months (individual endpoint evaluation points are listed in the secondary end points section); Secondary end point(s): •Leukocyte Telomere Length will be measured at baseline, 6 months and 1 year; short leukocyte telomere length is a predictor of cardiovascular mortality •CD8 T-cell telomere length will be measured at baseline, 6 months and 1 year; short telomere length is a predictor of cardiovascular mortality, and CD8 telomere length is significantly reduced in patients with coronary heart disease and post myocardial infarction. Isolated peripheral blood mononuclear cells (PBMCs) will be FACS sorted to purify CD8 cells. •The proportion of senescent (CD28-) CD4+ T-lymphocytes will be measured at baseline, 6 months and 1 year and calculated from the total number of CD4+ T-lymphocytes in each PBMC sample. CD28- CD4+ T-lymphocytes have been shown to be significantly increased in patients with acute coronary syndrome •The proportion of senescent (CD28-) CD8+ T-lymphocytes will be measured at baseline, 6 months and 1 year and calculated from the total number of CD8+ T-lymphocytes in each PBMC sample •Microvascular Endothelial Function will be assessed by measuring flow-mediated dilation (FMD) using finger plethysmography (EndoPat) at baseline, 6 months and 1 year. Using plethysmography at the fingertips of both hands, the EndoPAT system (Itamar Medical Ltd., Caesarea, Israel) will calculate an index of pulse wave amplitude after cuff occlusion to before occlusion of the test arm divided by the same ratio of the control limb, namely the reactive hyperemic index (RHI). FMD has been shown to be compromised in patients with diabetes as well as with coronary artery disease. It is a predictor of adverse clinical outcome. Endothelial dysfunction is seen as the initial step in atherogenesis. •Systemic Inflamma	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: baseline, 1, 3, 6, 9 and 12 months (individual endpoint evaluation points are listed in the secondary end points section); Secondary end point(s): •Leukocyte Telomere Length will be measured at baseline, 6 months and 1 year; short leukocyte telomere length is a predictor of cardiovascular mortality •CD8 T-cell telomere length will be measured at baseline, 6 months and 1 year; short telomere length is a predictor of cardiovascular mortality, and CD8 telomere length is significantly reduced in patients with coronary heart disease and post myocardial infarction. Isolated peripheral blood mononuclear cells (PBMCs) will be FACS sorted to purify CD8 cells. •The proportion of senescent (CD28-) CD4+ T-lymphocytes will be measured at baseline, 6 months and 1 year and calculated from the total number of CD4+ T-lymphocytes in each PBMC sample. CD28- CD4+ T-lymphocytes have been shown to be significantly increased in patients with acute coronary syndrome •The proportion of senescent (CD28-) CD8+ T-lymphocytes will be measured at baseline, 6 months and 1 year and calculated from the total number of CD8+ T-lymphocytes in each PBMC sample •Microvascular Endothelial Function will be assessed by measuring flow-mediated dilation (FMD) using finger plethysmography (EndoPat) at baseline, 6 months and 1 year. Using plethysmography at the fingertips of both hands, the EndoPAT system (Itamar Medical Ltd., Caesarea, Israel) will calculate an index of pulse wave amplitude after cuff occlusion to before occlusion of the test arm divided by the same ratio of the control limb, namely the reactive hyperemic index (RHI). FMD has been shown to be compromised in patients with diabetes as well as with coronary artery disease. It is a predictor of adverse clinical outcome. Endothelial dysfunction is seen as the initial step in atherogenesis. •Systemic Inflamma

—

Countries

United Kingdom

Contacts

Public ContactSarah Dunn

Newcastle Clinical Trials Unit

sarah.dunn2@newcastle.ac.uk01912082521

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026