ISRCTN46375134进行中（未招募）4 期
ESCALATion of medical therapy following multimodality plaque Evaluation in high-risk Chronic Coronary Syndromes
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Ability to provide written informed consent
- •2. Age 18 to 90 years old
- •3. Male, or female of non-child-bearing potential
- •4. Elevated clinical risk, as evidenced by =1 of:
- •4.1. Previous spontaneous acute myocardial infarction (diagnosed according to the universal MI criteria) with or without persistent ST-segment elevation
- •4.2. Previous stroke or intervention for peripheral arterial disease (i.e., evidence of atherosclerotic disease affecting >1 vascular bed)
- •4.3. Established diagnosis of diabetes mellitus
- •4.4. Systemic Coronary Risk Estimation 2 (SCORE2) or Systemic Coronary Risk Estimation 2 – Older Persons (SCORE2-OP) algorithm 10-year risk of fatal and non-fatal myocardial infarction or stroke >10%
- •5. Documented evidence of coronary artery disease, with an angiographically moderate stenosis on invasive coronary angiography (30-80%)
- •6. At least one non-flow limiting (FFR >0.80) moderate lesion with TCFA (minimum fibrous cap thickness of <120µm and lipid arc >90°)
- •7. History of prescribed statin therapy, at a stable dose, for >4 weeks
- •8. Evidence of residual inflammation at baseline (i.e., high-sensitivity CRP =2)
排除标准
- •1. Women who are pregnant, breastfeeding, or of child-bearing potential
- •2. Symptoms of unstable angina, characterised as: angina at rest; new onset of severe exertional angina (CCS grade III or higher for <4 weeks); or distinct, sudden, intensification of previously stable angina
- •3. Previous spontaneous acute myocardial infarction (diagnosed according to the universal MI criteria) with or without persistent ST-segment elevation <4 weeks from recruitment
- •4. Previous coronary artery bypass grafting
- •5. Known chronic total occlusion of coronary artery
- •6. Chronic kidney disease with eGFR <50 mL/min/1.73 m2 per MDRD formula or renal replacement therapy at baseline assessment
- •7. Known active or recurrent hepatic disorder (including cirrhosis, hepatitis B and hepatitis C, or confirmed ALT/AST levels > 3 times ULN or total bilirubin > 2 times ULN) at baseline assessment
- •8. Symptoms of severe heart failure (systolic or diastolic) with New York Heart Association (NYHA) Functional Classification 3 or 4
- •9. Moderate or severe valvular heart disease considered likely to require intervention
- •10. History of blood dyscrasia including anaemia, thrombocytopenia, neutrophilia, leukopenia or other abnormality of blood count at baseline
- •11. Peripheral neuritis, myositis or marked myo-sensitivity to statins
- •12. A history of alcohol and/or substance abuse that could interfere with the conduct of the trial
- •13. Patients with suspected or proven immunocompromised state, including:
- •13.1. Those with evidence of Human Immunodeficiency Virus (HIV) infection; Patients on anti-retroviral therapy are excluded
- •13.2. Those with any other medical condition which in the opinion of the investigator places the patient at unacceptable risk for participation in immunomodulatory therapy
- •14. History of hypersensitivity to the study drug or its constituents
- •15. Patients who have received an investigational drug or device within 30 days (inclusive) of baseline assessment, or who are expected to participate in any other investigational drug or device study during the conduct of this trial
- •16. Any biologic drugs targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, tocilizumab)
- •17. Established long-term pharmacotherapy with a strong CYP3A4 inhibitor or a P-glycoprotein inhibitor (P-gp) (e.g., macrolide antibiotics, ciclosporin, ketoconazole, itraconazole, voriconazole, HIV protease inhibitors, verapamil, diltiazem and disulfiram)
- •18. Contraindications to intravenous adenosine will exclude patients from adenosine induced hyperaemia
- •19. Any life-threatening condition with life expectancy <6 months that might prevent the patient from completing the study.
研究者
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