Apixaban vs. Warfarin in Left Ventricular Thrombus: A Randomized, Noninferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Complete Left Ventricular Thrombus Resolution at 3 Months
研究概览
简要总结
Left ventricular thrombus is a blood clot that forms in the left ventricle and is associated with risk of systemic embolism and ischemic stroke. Warfarin has historically been used for anticoagulation in this condition, but it requires frequent international normalized ratio monitoring and is affected by dietary and drug interactions. Apixaban is a direct oral factor Xa inhibitor with fixed dosing and no routine anticoagulation monitoring requirement, and it is increasingly used in clinical practice for left ventricular thrombus, although definitive randomized evidence remains limited.
This randomized, noninferiority trial will compare apixaban with warfarin for treatment of left ventricular thrombus. Eligible adults with recently confirmed left ventricular thrombus will be randomized 1:1 to apixaban or warfarin. The primary endpoint is complete left ventricular thrombus resolution at 3 months assessed by cardiac magnetic resonance imaging. Participants will be followed through 12 months for thrombus-related, bleeding, cardiovascular, and mortality outcomes.
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
- •Age ≥18 years
- •LV thrombus confirmed within 14 days prior to randomization by CMR or contrast TTE or cardiac CT; baseline CMR required pre-randomization (or ≤7 days post-randomization if clinically unavoidable)
- •Candidate for oral anticoagulation for ≥3 months
- •Able to provide informed consent.
排除标准
- •Absolute indication for VKA (mechanical valve, moderate-severe rheumatic MS and antiphospholipid syndrome) or clear preference or contraindication for one of the study drugs precluding randomization (see below)
- •Antiphospholipid syndrome
- •Estimated CrCl <15 mL/min or dialysis
- •Severe hepatic impairment (ICD-10: K70.40, K70.41, K71.10, K71.11, K72.00, K72.01, K72.10, K72.11, K72.90, K72.91)
- •Active clinically significant bleeding
- •Platelets <50,000/µL
- •Pregnancy or lactation; women of childbearing potential unwilling to use contraception
- •Life expectancy <1 year or other conditions compromising follow-up
- •Additional contraindications to use of warfarin or apixaban. This includes, but is not limited to:
- •Active pathological bleeding, major bleeding diathesis, or known blood dyscrasia
- •Recent or planned surgery involving the central nervous system or eye, traumatic surgery with large open surfaces, or procedures (spinal/epidural puncture or major regional block anesthesia) where bleeding cannot be safely controlled.
- •Conditions associated with high risk of bleeding such as threatened abortion, eclampsia, severe preeclampsia, or malignant/uncontrolled hypertension.
- •History of severe hypersensitivity or allergy to warfarin or apixaban.
- •Ongoing treatment with a combined P-gp and strong CYP3A4 inhibitor or inducer that cannot be safely discontinued or substituted. Examples include strong combined inhibitors such as ketoconazole, itraconazole, ritonavir or posiconazole, and strong combined inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.
结局指标
主要结局
Complete Left Ventricular Thrombus Resolution at 3 Months
时间窗: 3 months after randomization
Proportion of participants with complete resolution of left ventricular thrombus at 3 months, assessed by cardiac magnetic resonance imaging. The primary noninferiority comparison will use the absolute between-group difference in the proportion of participants with complete thrombus resolution, apixaban minus warfarin.
次要结局
- Major Bleeding(6 months)
- Change in LV Thrombus Volume(Baseline to 3, 6, or 12 months)
- Left Ventricular Remodeling(Baseline to 3, 6,12 months)
- Recurrent LV Thrombus(12 months)
- Ischemic Stroke(12 months)
- Systemic embolism(12 months)
- Cardiovascular Mortality(12 months)
- All-Cause Mortality(12 months)
研究者
Tushar Acharya
Associate Professor
University of Arizona