Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
A single-center, open-label, exploratory randomized controlled study is proposed with the following objectives: whether prolonging the duration of anticoagulation to 12 months, compared with 6 months of routine anticoagulation, helps to reduce major adverse cardiovascular and cerebrovascular events in patients with left ventricular thrombosis and to reduce recurrence of thrombosis, as well as to assess their bleeding risk.
Patients with a definite diagnosis of left ventricular thrombus and age ≥18 years were included in cardiac ultrasound (including general ultrasound and sonography) and other examinations during hospitalization and outpatient visits. Exclusion criteria were detailed in the study protocol.
GROUPING: According to the duration of anticoagulation, they were divided into extended anticoagulation group (12 months) and conventional anticoagulation group (6 months).
INTERVENTION: This study is planned to extend the administration of rivaroxaban (Pulsatilla) 20 mg to 12 months in the experimental group. The conventional anticoagulation group will take the drug for 6 months Study Endpoints: The primary efficacy endpoint is a major cardiovascular-vascular adverse event at 1 year; the primary safety endpoint is bleeding of grade 3 or higher as defined by the BARC classification at 1 year.
Patient Follow-up Program: Subjects will require a total of 12 on-site follow-up visits (one per month) for safety evaluation, efficacy evaluation, medication adherence evaluation, and imaging follow-up at months 3, 6, and 12.
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
- •①Patients who have been clearly diagnosed with left ventricular thrombus by inpatient or outpatient cardiac ultrasound (including general ultrasound and acoustic imaging).
- •②Age >= 18 years old
排除标准
- •Patients do not agree to participate in the study or have poor compliance in the past
- •Contraindication to anticoagulation or allergy to anticoagulants ③Have received oral anticoagulation after diagnosis of left ventricular thrombus.
- •Have undergone or are planning to undergo surgical procedures including left ventricular appendage thrombectomy, heart transplantation, ventricular wall tumor collapse, or valve replacement.
- •Presence of other long-term indications for anticoagulation, such as mechanical valve implantation, atrial fibrillation, etc.
- •Requirement for treatment with Tegretol and inability to change to clopidogrel bisulfate ⑦Presence of known malignant tumors, severe hepatic dysfunction (Child-Pugh classification B or less), severe renal dysfunction (creatinine clearance <30ml/min), anemia (Hb <100g/L), coagulation disorders and other underlying diseases, or life expectancy <3 years ⑧ Female patients are pregnant or breastfeeding ⑨ Patients with antiphospholipid syndrome
结局指标
主要结局
Primary efficacy endpoint
时间窗: Patient completes one year of follow-up
for major cardiovascular and cerebrovascular adverse events at 1 year, including: all-cause mortality, nonfatal heart attack, ischemic stroke, and acute peripheral artery embolism. fatal heart attack, ischemic stroke, and acute peripheral artery embolism
次要结局
- secondary endpoint(Patient during one year of follow-up)
研究者
Weihua Song
MD
Chinese Academy of Medical Sciences, Fuwai Hospital