Randomized Trial of Rivaroxaban (Xarelto) and Apixaban (Eliquis) for the Prevention of Endothermal Heat-Induced Thrombosis (EHIT) and Deep Vein Thrombosis After Great Saphenous Vein Endovenous Laser Ablation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 564
- 试验地点
- 1
- 主要终点
- Incidence of clinically significant EHIT (AVF class ≥II)
研究概览
简要总结
Endothermal heat-induced thrombosis (EHIT) is a thrombotic complication specific to endovenous thermal ablation of the great saphenous vein (GSV), for which no prophylactic regimen is standardized. This single-centre, single-operator randomized trial compared a brief 5-day post-procedural course of the direct oral anticoagulants apixaban and rivaroxaban against no anticoagulation for the prevention of EHIT after GSV endovenous laser ablation performed with concurrent below-knee foam sclerotherapy. Treated limbs were randomly allocated 2:1:1 (no anticoagulant : rivaroxaban : apixaban), and EHIT was graded on post-ablation duplex by the American Venous Forum (AVF) classification.
详细描述
The unit of randomization was the treated limb, assigned by a computer-generated random sequence. Some participants underwent bilateral procedures and could contribute limbs to different arms; within-participant correlation was addressed with patient-clustered robust standard errors and a one-limb-per-patient sensitivity analysis. The primary endpoint was clinically significant (AVF class ≥II) EHIT on the first post-ablation duplex, which was performed and interpreted by two registered vascular technologists blinded to treatment allocation, with adjudication by the treating physician.
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
- Single (Outcomes Assessor)
盲法说明
Who is masked: Outcomes Assessor (duplex read by blinded technologists)
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
- •Adults aged 18 years or older Undergoing great saphenous vein endovenous laser ablation for symptomatic reflux Concurrent below-knee foam sclerotherapy
排除标准
- •Known thrombophilia Current oestrogen or hormone-replacement therapy Family history of venous thromboembolism or thrombophilia Active malignancy Prior ipsilateral ablation Deep venous reflux or obstruction
研究组 & 干预措施
No anticoagulant
"No anticoagulant" · No Intervention · no post-procedural anticoagulant
apixaban
Experimental · apixaban 5 mg orally twice daily for 5 days from the day of the procedure
干预措施: Apixaban (Drug)
rivaroxaban
Experimental · rivaroxaban 20 mg orally once daily for 5 days from the day of the procedure
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Incidence of clinically significant EHIT (AVF class ≥II)
时间窗: Up to 1 week after the ablation procedure
Incidence of clinically significant EHIT (AVF class ≥II)
Number of Limbs With Clinically Significant EHIT (AVF Class ≥II)
时间窗: Up to 1 week after the ablation procedure
Incidence of clinically significant EHIT (AVF class ≥II)
次要结局
- Any EHIT (AVF class I-IV) - first post-ablation duplex(Up to 1 week after the ablation procedure)
- Remote (non-contiguous) deep vein thrombosis(Up to 1 week after the ablation procedure)
- Treated great saphenous vein closure(Up to 3 years after the ablation procedure)
- Bleeding (ISTH major / clinically relevant non-major / minor)(Up to 30 days after the ablation procedure)
- Number of Limbs With Any EHIT (AVF Class I-IV)(Up to 1 week after the ablation procedure)
- Number of Limbs With Remote (Non-contiguous) Deep Vein Thrombosis(Up to 1 week after the ablation procedure)
- Number of Limbs With Treated Great Saphenous Vein Closure(Up to 3 years after the ablation procedure)
- Number of Limbs With Bleeding (ISTH Major, CRNM, or Minor)(Up to 30 days after the ablation procedure)
研究者
sanjay srivatsa
Title: Principal Investigator · Affiliation: Heart Artery and Vein Center of Fresno
Heart, Artery, and Vein Center of Fresno