EFFICACY OF COLCHICINE IN SECONDARY PREVENTION OF VASCULAR EVENTS AND RENAL PROGRESSION IN PATIENTS WITH MODERATE CHRONIC RENAL DISEASE (COLCHIREN STUDY).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 744
- 试验地点
- 27
- 主要终点
- incidence of the primary event consisting of: death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalisation; coronary revascularisation; transient ischaemic attack or non-cardioembolic ischaemic stroke; or peripheral vascular disease, defined as acute peripheral arterial embolism or ischaemia, or the need for amputation or percutaneous surgical revascularisation
研究概览
简要总结
To assess the benefit of low-dose colchicine treatment (0. 5 mg/day) in the secondary prevention of cardiovascular events (incidence of the primary event consisting of: cardiovascular death; acute coronary syndrome; angina requiring hospitalisation; coronary revascularisation; transient ischaemic attack or non-cardioembolic ischaemic stroke; or peripheral vasculopathy, defined as acute peripheral arterial embolism or ischaemia, or need for amputation or percutaneous surgical revascularisation) in patients with moderate chronic kidney disease
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
- 否
入选标准
- •Age between 18 and 99 years. - Moderate chronic kidney disease, defined as a glomerular filtration rate estimated by the CKD-EPI formula between 30 and 59 mL/min/1.73m
- •History of having suffered a previous cardiovascular event: o Acute coronary syndrome. o Admission for angina pectoris. o Transient ischemic attack or non-cardioembolic ischemic stroke. o Coronary revascularization. o Confirmed diagnosis of peripheral vascular disease (PVD) based on clinical criteria and/or imaging studies, including: Decreased or absent pulses in the femoral, popliteal, tibial or pedial arteries with clinical signs of intermittent claudication or. Abnormal results on blood flow studies: ankle-brachial index (ABI) less than 0.9 or. Angiographic evidence of stenosis, occlusions or aneurysms in peripheral arteries. . o Finding of coronary artery disease on imaging test. - Legal capacity and voluntary willingness to sign informed consent.
排除标准
- •History of allergy or intolerance to colchicine or any of its excipients (calcium hydrogen phosphate dihydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate). - Current treatment with colchicine, or during the month prior to inclusion. - Hospital admission of any cause in the 3 months prior to inclusion in the study. - Active malignant neoplasm (except non-melanoma skin cancer or carcinoma in situ). Patients with a history of malignant neoplasia who have remained free of disease during the previous 3 years can be included. - Uncontrolled or symptomatic chronic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, ulcerative colitis, etc.). - Active infection by hepatitis B virus, hepatitis C virus or human immunodeficiency virus. - Liver cirrhosis of any cause Child-Pugh grade B or C. - Immunosuppressive treatment in the 12 weeks prior to inclusion in the study. - Chronic treatment with non-steroidal anti-inflammatory drugs. - Poorly controlled arterial hypertension (>160/90 mmHg) at the inclusion visit.
- •Pregnancy and lactation in the inclusion. The use of contraceptive methods is required for women with gestational capacity. Women with gestational capacity are not considered those with: o History of hysterectomy, double salpingectomy, double oophorectomy, or bilateral tubal ligation. o Documented infertility. o Postmenopausal women, defined as amenorrhea for more than 12 months with no other medical cause. In case of doubt, confirmation with elevated follicle stimulating hormone (FSH) levels is recommended. In women with gestational capacity, the use of a contraceptive method of proven effectiveness is required up to 8 weeks after the end of the study. Acceptable methods are as follows: o intrauterine device (IUD) implantation at least 6 weeks prior to study inclusion. o Progestogen-only hormonal contraception associated with ovulation inhibition: oral, injectable, implantable at least 6 weeks prior to study enrollment. o Intrauterine progestin-releasing system at least 6 weeks prior to study enrollment. Combined hormonal contraception (containing estrogens and progestogens) associated with ovulation inhibition : oral, intravaginal , transdermal at least since 6 weeks prior to study inclusion. Other contraceptive methods (sexual abstinence, barrier methods, spermicides, etc.) are not considered acceptable for the study.
- •Gastric ulcer. - Thrombocytopenia defined as <50000 cells/mcL during the month prior to inclusion. - Neutropenia defined as <1500 cells/mcL during the month prior to inclusion. - Anemia defined as hemoglobin <10.5 g/dL during the month prior to inclusion. - History of aplastic anemia diagnosed by bone marrow biopsy. - Treatment with CYP3A4 and/or P-glycoprotein inhibitors (antivirals, azole antifungals, aminoglycosides, cisclosporin) in the month prior to inclusion in the trial. Treatment with CYP3A4 and/or P-glycoprotein inhibitors (antivirals, azole antifungals, aminoglycosides, cisclosporin) in the month prior to inclusion in the trial.
结局指标
主要结局
incidence of the primary event consisting of: death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalisation; coronary revascularisation; transient ischaemic attack or non-cardioembolic ischaemic stroke; or peripheral vascular disease, defined as acute peripheral arterial embolism or ischaemia, or the need for amputation or percutaneous surgical revascularisation
incidence of the primary event consisting of: death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalisation; coronary revascularisation; transient ischaemic attack or non-cardioembolic ischaemic stroke; or peripheral vascular disease, defined as acute peripheral arterial embolism or ischaemia, or the need for amputation or percutaneous surgical revascularisation
Incidence of primary event consisting of death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or noncardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or surgical or percutaneous revascularization.
Incidence of primary event consisting of death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or noncardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or surgical or percutaneous revascularization.
次要结局
- - Incidence of death from cardiovascular causes. - Incidence of acute coronary syndrome. - Incidence of hospitalization for cardiac angina. - Incidence of coronary revascularization. - Incidence of transient ischemic attack or noncardioembolic ischemic stroke. - Incidence of peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or percutaneous surgical revascularization.
- - Individual and combined incidence of renal events: o 40% decrease in glomerular filtration rate estimated by CKD-EPI with respect to baseline. o Doubling of serum creatinine over its baseline level. o Persistent drop in glomerular filtration rate estimated by CKD-EPI below 15 mL/min/1.73m2. o Need for renal replacement therapy on a sustained basis. - Effect on plasma levels of markers of inflammation, fibrosis and renal progression. - Incidence of adverse events.
研究者
María del Carmen de la Cruz
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon