The Effect of Replacement of Vitamin K Antagonist by Rivaroxaban With or Without Vitamin K2 Supplementation on Vascular Calcifications in Chronic Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- absolute and relative change in coronary artery calcification score
研究概览
简要总结
This study examines patients on chronic hemodialysis with non-valvular atrial fibrillation, who have a CHA2DS2-VASc Score of ≥ 2 and therefore are candidates for or already receive a vitamin K antagonist.
The first question is whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification. The second question is whether addition of vitamin K2 to rivaroxaban can further slow down or even halt the progression of vascular calcification.
详细描述
The present study targets dialysis patients with non-valvular atrial fibrillation requiring treatment with vitamin K antagonists. It addresses the question whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification (VC). The second research question is whether addition of vitamin K2 to rivaroxaban can further beneficially affect the progression of VC. Two non-invasive methods are used to evaluate the impact of interventions on the progression of VC: i.e. coronary artery calcification (CAC) and pulse wave velocity (PWV) measurements. The detection of CAC is predictive for the presence of obstructive coronary artery disease and future coronary events. VC and stiffening of the central elastic-type arteries are independent predictors of cardiovascular morbidity and mortality in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •end stage renal failure treated with chronic hemodialysis
- •atrial fibrillation
- •CHA2DS2-VASc Score ≥ 2
- •ability to provide informed consent
排除标准
- •known intestinal malabsorption or inability to take oral medication
- •inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, rifampicin, phenytoin, carbamazepine, phenobarbital or St John's wort)
- •investigator's assessment that the subject's life expectancy is less than 1 year
- •prosthetic mechanical heart valve
- •contraindication for anticoagulation
- •liver dysfunction Child-Pugh grade B-C
- •pregnancy, breastfeeding, inadequate contraception
- •incompliance with medication and scheduled investigations
研究组 & 干预措施
rivaroxaban
Rivaroxaban 10 mg tablet by mouth once daily for 18 months
干预措施: rivaroxaban (Drug)
rivaroxaban and vitamin K2
Rivaroxaban 10 mg tablet by mouth once daily and MK-7 2000 microgram tablet by mouth thrice weekly for 18 months
干预措施: rivaroxaban (Drug)
rivaroxaban and vitamin K2
Rivaroxaban 10 mg tablet by mouth once daily and MK-7 2000 microgram tablet by mouth thrice weekly for 18 months
干预措施: Vitamin K2 (Dietary Supplement)
结局指标
主要结局
absolute and relative change in coronary artery calcification score
时间窗: 18 months
score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)
absolute and relative change in thoracic aortic calcification score
时间窗: 18 months
score measured by unenhanced electrocardiographically-gated CT of the heart and thoracic aorta and calculated on 2.5 mm slices using Smartscore v.4.0 (GE Healthcare)
absolute and relative change in pulse wave velocity
时间窗: 18 months
次要结局
- absolute and relative change in aortic valve calcification score(18 months)
- absolute and relative change in mitral valve calcification score(18 months)
- mortality from any cause(18 months)
- myocardial infarction, acute coronary syndrome, symptom-driven coronary revascularization and death from cardiovascular cause(18 months)
- Stroke, defined as sudden onset of focal neurological deficit consistent with the territory of a major cerebral artery and categorised as ischaemic, haemorrhagic, or unspecified.(18 months)
- Systemic embolism, defined as an acute vascular occlusion of a limb or organ documented by imaging, surgery, or autopsy.(18 months)
- Major bleeding, defined as a requirement for transfusion of two or more units of blood or a decrease in haemoglobin of 2 g/dL or more.(18 months)
- Life-threatening bleeding, defined as fatal bleeding, symptomatic intracranial bleeding, a decrease in haemoglobin of 5 g/dL or more, or a requirement for transfusion of four or more units of blood, inotropic agents, or surgery.(18 months)
研究者
Rogier Caluwe
Dr. Rogier Caluwé, MD
Onze Lieve Vrouw Hospital