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)

South Tees Hospitals NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2017年10月25日最近更新: 2019年6月30日

试验速览

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•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

•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

发起方