ISRCTN16613292已完成未知
Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome: a double-blind, phase II, pilot randomised controlled trial (TACTIC)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32965237/ protocol (added 24/09/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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