2024-514416-28-00招募中4 期
An investigator-initiated, multicenter, open-label, parallel arm, active comparator, randomized study to compare the efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with left ventricular thrombus after acute myocardial infarction.
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 16
- 主要终点
- Thrombus resolution will be evaluated by TTE (Transthoracic echocardiogram), preferably contrast-enhanced, at 3 months. Should TTE be inconclusive, cardiac magnet resonance imaging (MRI) or cardiac computed tomography (CCT) is recommended to evaluate the primary endpoint.
研究概览
简要总结
The primary objective of this study is to compare the effect of apixaban versus warfarin with respect to thrombus resolution in patients with left ventricular thrombus after acute myocardial infarction (AMI).
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
- Single (Outcomes Assessor)
盲法说明
Assessment of the primary outcome of thrombus resolution will be performed through review of images by researchers who are blinded to the treatment assignment
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥ 18 years at the time of signing the informed consent.
- •Left ventricular thrombus confirmed on transthoracic echocardiogram (TTE) or when inconclusive documented on cardiac magnet resonance imaging (MRI) or computed tomography (CT) on day 1-28 after the acute myocardial infarction.
- •The subject has given their written consent to participate in the trial which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and study protocol.
- •Criteria applicable only for female subjects: A) Women of childbearing potential must provide a negative pregnancy test at inclusion, not be breastfeeding and be willing and able to use highly effective contraception during the treatment and up to 3 months after the last dose of study drug; B) Women of non-childbearing potential must be 1 year post-menopausal.
排除标准
- •Ongoing treatment with anticoagulant therapy due to: A) Mechanical heart valve prosthesis (not including transcatheter aortic valve replacement); B) Atrial fibrillation with or without significant mitral valve stenosis; C) Venous thromboembolism requiring anticoagulant therapy; D) Thrombophilia requiring anticoagulant therapy; E) Preexisting left ventricular thrombus already on anticoagulant therapy; F) Other reasons for anticoagulant therapy.
- •High bleeding risk: A) Active non-trivial bleeding; B) Known chronic bleeding disorder; C) Severe anemia defined as hemoglobin < 80g/L; D) Thrombocytopenia defined as thrombocytes <80 x 10^
- •Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or known hepatic insufficiency classified as Child-Pugh C or D at randomization.
- •Known allergy, intolerance or hypersensitivity to either of the study interventions (active substance or excipients).
- •Any contraindication for the use of an anticoagulant or listed in the local labelling for Apixaban or warfarin.
- •Participation in other study investigating effects and safety of anticoagulant treatment.
- •Known current alcohol or drug abuse that may interfere with participants safety and or compliance as judged at the discretion of the investigator.
- •Any other condition, as judged by the investigator, that would make the participant unsafe or unsuitable for the study (anticipated non-compliance or vulnerability) or very short life expectancy < 6 months.
结局指标
主要结局
Thrombus resolution will be evaluated by TTE (Transthoracic echocardiogram), preferably contrast-enhanced, at 3 months. Should TTE be inconclusive, cardiac magnet resonance imaging (MRI) or cardiac computed tomography (CCT) is recommended to evaluate the primary endpoint.
Thrombus resolution will be evaluated by TTE (Transthoracic echocardiogram), preferably contrast-enhanced, at 3 months. Should TTE be inconclusive, cardiac magnet resonance imaging (MRI) or cardiac computed tomography (CCT) is recommended to evaluate the primary endpoint.
次要结局
- Clinically relevant bleeding - BARC (Bleeding Academy Research Consortium) 2, 3 or 5 bleeding.
- Major bleeding BARC 3 or 5 bleeding.
- Individual bleeding endpoints (Fatal bleeding, intracranial hemorrhage, GI bleeding, urogenital bleeding and bleeding of other sources).
- Major adverse cardiovascular events (MACE). Composite of non-fatal myocardial infarction, non-fatal ischemic stroke and cardiovascular death.
- Net clinical benefit: Composite of MACE and BARC 2, 3 or 5 bleeding.
- Ischemic stroke and systemic embolism.
- Recurrence of LV thrombus at 12 months.
研究者
FOU
Scientific
Karolinska Institutet
研究点 (16)
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