2024-518100-45-00招募中3 期
COLchicine to mitigate accelerated Atherosclerosis induced by immune checkpoint inhibitors in patients with cancer: the COLA trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in maximum target-to-background ratio (TBRmax) in coronary arteries, which quantifies 68Gallium-DOTATATE uptake, between baseline and 12-week follow-up on PET-scan.
研究概览
简要总结
To evaluate the effect of colchicine on coronary vessel wall inflammation
研究设计
- 分配方式
- Randomized
- 主要目的
- Open-label randomized controlled trial
- 盲法
- None
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
- •Age 50 years or older
- •Planned for treatment with a PD-1 or PD-L1 inhibitor for at least 3 months
- •Signs of atherosclerosis on imaging (e.g. coronary artery calcium score >0 on cancer staging chest CT-scan or calcifications of aorta, abdominal arteries, or iliac arteries abdomino/pelvic CT-scan)
排除标准
- •Chest radiation therapy in prior 3 months (or planned during the study)
- •Moderate or severe renal impairment (eGFR <50 mL/min/1.73 m2 based on CKD-EPI)
- •Child Pugh B or C liver cirrhosis
- •Known intolerance to colchicine
- •Use of immunosuppressive medication at randomization
- •Use of strong CYP3A4 inhibitors
- •Colchicine use in previous <3 months
- •Indication for long-term treatment with colchicine
- •Inability to provide written informed consent
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Change in maximum target-to-background ratio (TBRmax) in coronary arteries, which quantifies 68Gallium-DOTATATE uptake, between baseline and 12-week follow-up on PET-scan.
Change in maximum target-to-background ratio (TBRmax) in coronary arteries, which quantifies 68Gallium-DOTATATE uptake, between baseline and 12-week follow-up on PET-scan.
次要结局
- TBRmax in carotid arteries
- TBRmax in aorta
- Mean standardized uptake value (SUVmean) in spleen
- SUVmean in bone marrow
- Coronary artery calcium score
- All-cause mortality
- Major adverse cardiovascular events (i.e. myocardial infarction, ischemic stroke, ischemia-driven coronary revascularisation, death)
- Immune related adverse events
- Biomarkers (e.g. blood inflammatory markers, PBMCs, plasma cytokines, metabolomics, and microbiome composition)
研究者
Principal investigator
Scientific
Amsterdam UMC Stichting
研究点 (1)
Loading locations...
相似试验
招募中
3 期
COLchicine in BElgium in patients with coronary artery disease after Percutaneous Coronary Intervention2023-505028-74-00Universitair Ziekenhuis Gent, Az St-Jan Brugge-Oostende A.V.2,770
招募中
4 期
Colchicine's Effect on Inflammatory MarkersNCT07287345Ayesha Ather24
招募中
2 期
Clinical trial of colchicine to reduce coronary artery inflammation in people with HIV.2024-520346-39-00Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz104
招募中
1 期
Colchicine Effect on Perivascular Inflammation Index on Coronary CTAInflammatory ResponseCoronary DiseaseAtherosclerosisNCT05347316University of Sao Paulo General Hospital40
已完成
2 期
CONCISE
COlchicine iN Circulating Inflammatory markers after StrokEStroke2023-506967-33-00University College Dublin120