Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Efficacy on coagulation parameters
研究概览
简要总结
Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and with vitamin K oral anticoagulants.
详细描述
Parameters evaluated:
- anthropometric indices
- glycated haemoglobin, basal and postprandial glycemia
- lipid profile
- small and dense LDL; oxidized LDL
- I troponin
- red and white cells count; platelets count
- creatinin, transaminases, iron
- fibrinogen, D-dimer, anti-thrombin III
- Hs-CRP, metalloproteinases 2 and 9
- incidence of bleeding
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •non-valvular atrial fibrillation
- •nondiabetic patients
- •type 1 and 2 diabetic patients
排除标准
- •patients with cancer
- •patients with chronic inflammation diseases
研究组 & 干预措施
Nondiabetics (group 1)
Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way
干预措施: Dabigatran (Drug)
Nondiabetics (group 1)
Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way
干预措施: Apixaban (Drug)
Nondiabetics (group 1)
Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way
干预措施: Rivaroxaban (Drug)
Nondiabetics (group 1)
Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way
干预措施: Edoxaban (Drug)
Diabetics (group 1)
Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way
干预措施: Dabigatran (Drug)
Diabetics (group 1)
Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way
干预措施: Apixaban (Drug)
Diabetics (group 1)
Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way
干预措施: Rivaroxaban (Drug)
Nondiabetics (group 2)
Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
干预措施: Warfarin (Drug)
Diabetics (group 1)
Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way
干预措施: Edoxaban (Drug)
Nondiabetics (group 2)
Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
干预措施: Acenocumarole (Drug)
Diabetics (group 2)
Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
干预措施: Warfarin (Drug)
Diabetics (group 2)
Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
干预措施: Acenocumarole (Drug)
结局指标
主要结局
Efficacy on coagulation parameters
时间窗: 12 months
D-dimer, anti-thrombin III
次要结局
- Bleeding risk(12 months)
- Endothelial damage(12 months)
- Inflammation parameters(12 months)
- Oxidative status(12 months)
- Heart damage(12 months)
- Safety and tolerability parameters(12 months)
研究者
Giuseppe Derosa
Principal Investigator
University of Pavia