Telomerase activator TA-65MD® in patients with ACS (TACTIC)

Not Applicable

Completed

• Conditions: Coronary heart disease; Circulatory System; Chronic ischaemic heart disease, unspecified

• Registration Number: ISRCTN16613292
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32965237/ protocol (added 24/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-30
• Study Completion: 2021-04-30
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Able to give written informed consent
2. Patients aged 65 or over with an index presentation of an acute coronary syndrome* within the previous 6 months
3. Successfully completed revascularisation** or managed medically following ACS
4. Angiographic evidence of coronary heart disease (at least one major epicardial vessel stenosis =70%)
5. 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)

Exclusion Criteria

Updated participant exclusion criteria (as of 12/09/2018):
1. Patients with any disorder associated with immunological dysfunction (acute or chronic inflammatory or neoplastic co-existing disease, known positive serology for HIV, or hepatitis)
2. Clinically unstable patients (haemodynamically unstable, cardiogenic shock, unconscious)
3. Severe, uncontrolled hypertension (Blood Pressure > 170/110 mmHg, or ambulatory BP of 150/95 mmHg)
4. Severe comorbidity that has an impact on outcome over next 2 years
5. Taking immunosuppressants
6. Known malignancy
7. Insulin-controlled diabetes
8. 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 or if the patient had a previous diagnosis of a serious psychiatric disease
9. Participation in any other interventional medicinal studies in the past 6 months
10. Previous known substance addiction
11. Current use of nutritional supplements derived from roots of the Astragalus species

Previous participant exclusion criteria:
1. Patients with any disorder associated with immunological dysfunction (acute or chronic inflammatory or neoplastic co-existing disease, known positive serology for HIV, or hepatitis)
2. Clinically unstable patients (haemodynamically unstable, cardiogenic shock, unconscious)
3. Severe, uncontrolled hypertension (Blood Pressure > 170/110 mmHg, or ambulatory BP of 150/95 mmHg)
4. Severe comorbidity that has an impact on outcome over next 2 years
5. Taking immunosuppressants
6. Known malignancy
7. Insulin-controlled diabetes
8. 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
9. Participation in any other interventional medicinal studies in the past 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified