2022-500850-40-01招募中3 期
The Colchicine and atrial fibrillation trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Time to first AF admission from start of medication measured in days
研究概览
简要总结
The purpose of this study is to investigate the beneficial effects of colchicine on Atrial Fibrillation and atrial flutter (henceforth under joint abbreviation as AF) recurrence in patients scheduled for electrical cardioversion for AF. We expect the results of this clinical trial to indicate whether colchicine should be repurposed for the treatment of paroxysmic/persistent AF.
研究设计
- 分配方式
- Randomized
- 主要目的
- Enrollment and 1 year follow up
- 盲法
- Double (Monitor, Carer, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with paroxystic/persistent AF
- •Planned or acute admission for cardioversion of AF with successful outcome
- •Female participants 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
- •Participants will have given written, informed consent and are able and willing to comply with the requirements of the study protocol
- •Optimal background therapy (in relation to comorbidities and development of heart failure / thromboembolic event) for AF as judged by the investigator
排除标准
- •Colchicine treatment for another cause, e.g. gout
- •Allergy/hypersensitivity to colchicine
- •Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
- •History of malignancy of any organ system within the last 5 years 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
- •Cirrhosis, chronic active hepatitis or other severe hepatic disease
- •Hemodialysis
- •Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2
- •Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1)
- •Permanent AF
- •Suspected AF, confirmed with ECG, at time of inclusion and randomization
- •Female participants who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion
- •Significant drug or alcohol abuse during the last year
- •Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
- •Planned ablation procedure as treatment for AF
- •If cardiovascular surgery or ablation has been done the past three months prior to inclusion
- •Chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
- •Use of other investigational drugs within 30 days of the time of enrollment
- •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
结局指标
主要结局
Time to first AF admission from start of medication measured in days
Time to first AF admission from start of medication measured in days
次要结局
- Accumulated number of readmissions for symptomatic AF at 12 months
- Change in echocardiographic measurements at 12 months
- Change of life quality score at 12 months
- Change in potentiel side effects at 12 months
研究者
Adam Femerling Langhoff
Scientific
Gentofte Hospital
研究点 (1)
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