EUCTR2020-004492-40-DK进行中（未招募）1 期
COHERENT - The COlchicine HypERtENsion Trial - COHERENT
Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital0 个研究点目标入组 150 人开始时间: 2020年10月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Living address in the Capital Region of Denmark
- •2) Age >18 years
- •3) Diagnosed with hypertension
- •4) Treatment with 1 or more antihypertensive medications
- •5) Must fulfill at least one of the following high-risk criteria:
- •a) Diagnosed with type 2 diabetes mellitus OR
- •b) Treatment with lipid-lowering medication for dyslipidemia OR
- •c) Treatment with 2 or more antihypertensive medications
- •6) Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
- •7) Patients will have given written, informed consent and are able and willing to comply with the requirements of the study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1) Colchicine treatment for another cause, e.g. gout
- •2) Allergy/hypersensitivity to colchicine
- •3) Known or suspected secondary hypertension, e.g. renal artery stenosis
- •4) Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
- •5) Known other cardiovascular disease (judged by the investigator), e.g. ischemic heart disease, heart failure, significant valvular disease, arrhythmia, stroke, or peripheral artery disease
- •6) History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix
- •7) Cirrhosis, chronic active hepatitis or other severe hepatic disease
- •8) Hemodialysis
- •9) Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
- •10) Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors
- •11) Anemia, thrombocytopenia or leucopenia defined as any of the following measurements within the last 3 months:
- •- Hemoglobin < 7 mmol/L
- •- Platelet count < 110 x 10^9/L
- •- White blood cell count < 3.0 x 10^9/L
- •12) Female patients who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion
- •13) Significant drug or alcohol abuse during the last year
- •14) Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
- •15) Chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
- •16) Use of other investigational drugs within 30 days of the time of enrollment
- •17) Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
研究者
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