2023-505028-74-00招募中3 期
COLchicine in BElgium in patients with coronary artery disease after Percutaneous Coronary Intervention
Universitair Ziekenhuis Gent, Az St-Jan Brugge-Oostende A.V.22 个研究点 分布在 1 个国家目标入组 2,770 人开始时间: 2023年9月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,770
- 试验地点
- 22
- 主要终点
- The primary endpoint is time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.
研究概览
简要总结
To demonstrate that colchicine 0.5 mg daily reduces first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction, non-fatal stroke, or coronary revascularisation, whichever occurs first, in patients with CAD treated with PCI.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomised, double-blind, multicenter, placebo-controlled phase III pragmatic superiority trial
- 盲法
- Double (Monitor, Subject, Analyst, Investigator, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥45 years.
- •Coronary artery disease treated with PCI and optimal medical therapy, with at least one additional risk factor (based on SMART): a. Age ≥ year b. Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5% c. Current smoking d. Treated hypertension or lood pressure systolic ≥ 4 mmHg or diastolic ≥ mmHg e. Total cholesterol >240 mg/dl untreated, or treated LDL >70 mg/dl f. HDL <40 mg/dl g. hsCRP >2 mg/dl AND chronic coronary syndrome (CCS) h. eGFR <60 ml/min (MDRD) i. history of vascular disease: • CAD (PCI prior to index, CABG, MI) • stroke (ischemic or hemorrhagic) • carotid artery revascularisation • PAD (revascularisation, ABI <0.85 at rest, amputation due to atherosclerotic disease) • AAA (repair, distal aortic anteroposterior diameter >3.0cm)
- •Able to be enrolled/randomized between 2 hour and 5 days post PCI.
- •Written informed consent.
排除标准
- •Women who are pregnant, breastfeeding, or of childbearing potential who are not using an effective method of contraception. Or women who intend to donate oocytes.
- •Current or planned use of any strong inhibitor of CYP3A4 or p-glycoprotein: macrolide antibiotics (clarithromycin, telithromycin), azole antifungal agents (ketoconazole, voriconazole, fluconazole, itraconazole), cyclosporine, HIV medication (ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir).
- •Chronic diarrhea, or inflammatory owel disease (Crohn’s disease or ulcerative colitis).
- •Drug or alcohol abuse.
- •Planned coronary, carotid or peripheral revascularisation known on the day of screening.
- •Currently enrolled in another investigational trial.
- •Considered to be an unsuitable candidate by the investigator.
- •Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. Or men who intend to donate sperm.
- •Any contraindication or known intolerance to colchicine.
- •Chronic use of -or need for- colchicine.
- •Auto-immune disease requiring current or planned chronic systemic steroids, immunosuppressant or biologic drug targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, tocilizumab etc.).
- •Creatinine clearance <30 mL/min/1.73 m
- •Cirrhosis Child-Pugh stadium B and C, or acute severe liver disease
- •Neuromuscular disease or non-transient CK levels > 5 x ULN (unless due to MI).
- •History of cancer or lymphoproliferative disease within the last 3 years, other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, or localized cervix carcinoma in situ.
结局指标
主要结局
The primary endpoint is time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.
The primary endpoint is time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.
次要结局
- Time from randomisation to first occurrence of: ▪ a composite of specific cardiovascular endpoint consisting of: cardiovascular death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke or coronary revascularisation ▪ a composite of hard endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke ▪ Breakdown components of primary endpoint and atherosclerosis-related diseases
- Time from randomisation to occurrence of first as well as recurrent endpoints consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction (Type 1, 4B & C), non-fatal stroke, or coronary revascularisation.
- Change from randomisation to year 1 and to end of study of participants reported outcomes (based on ICHOM Standard Set for CAD) o Seattle Angina Questionnaire (SAQ) Angina Frequency Scale o Dyspnea (Rose Dyspnea Scale) o Depression (Patient Health Questionnaire PHQ-2)
研究者
Ian Buysschaert
Scientific
Universitair Ziekenhuis Gent
研究点 (22)
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