Prospective Study With Biological Assessment: Evolution of Coagulation Activity in Non Valvular Atrial Fibrillation Patients Under Apixaban
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- change from baseline D-dimers level at 3 months.
研究概览
简要总结
Apixaban is a potent, oral, selective reversible direct inhibitor of factor Xa with a favorable efficacy and safety profile in the prevention of non valvular (NV) atrial fibrillation (AF). It has been shown, including by our group, that D-dimers levels (molecular marker of coagulation activity) are predictive of the events (including mortality) in patient with AF independently of the antithrombotic treatment. The aim of the study is to evaluate the changes in plasma levels of biomarkers of coagulation activation: D-dimers, prothrombin fragments F1+2, von Willebrand factor (vWF) and thrombin-antithrombin complexes (TAT) in response to apixaban treatment in patients with NVAF.
详细描述
This study is a prospective, monocentric study, with biological analyses. The investigational product will be administered according to French health agency. The duration of the study for each patient will be 3 months with 3 visits and from 3 to a maximum of 18 months for the clinical follow-up.
Hypothesis: Apixaban significantly decreases D-dimers and other markers of coagulation activation in patients with NVAF ( paroxysmic and chronic atrial fibrillation).
Primary endpoint:
Measurement of D-dimers at baseline (before apixaban treatment) and under chronic apixaban treatment at 3 months in the overall population.
Secondary endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with NVAF (documented by 12 leads ECG or Holter recording) and having one or more factor (s) of risk such as: history of stroke or transient ischemic attack ; age≥75 years; hypertension; diabetes; symptomatic heart failure (NYHA class≥ II) for prevention of cerebral vascular accident and systemic embolism.
- •Patients with CHA2DS2-VASc score ≥2
- •Patients provided signed written informed consent
- •Patients with age≥18 years
- •Patients previously treated with VKA or patients newly diagnosed with AF.
排除标准
- •AF or flutter due to reversible causes according to investigator
- •Clinically significant mitral stenosis
- •Any other condition than atrial fibrillation that require chronic anticoagulation (prosthetic heart valve or valve repair, venous thromboembolism)
- •A need for aspirin at a dose of ≥160 mg a day or for both aspirin and adenosine diphosphate (ADP) inhibitor (clopidogrel, prasugrel or ticagrelor)
- •Allergy or adverse reaction to apixaban or any of the excipients
- •Patients previously treated by an oral direct anticoagulant in the last 30 days
- •Patient with clinically on going active bleeding or platelet count<100,000/mm3 or haemoglobin<9 g/dL
- •Patients with serious bleeding in the last 6 months or with high risk of bleeding (active peptic ulcer disease or gastroduodenal ulceration, known or suspected esophageal varicoses, recent ischemic stroke, recent brain or spinal injury or intracranial hemorrhage, recent surgery, arterial or venous malformations, vascular aneurysms...)
- •Patients with another cause of increase of D-dimers (active malignant neoplasm, recent trauma or surgery (less than 1 month), extensive venous malformation...)
- •Uncontrolled and persistent hypertension (systolic >180 mmHg or diastolic >100 mmHg)
- •Active infective endocarditis
- •aspartate transaminase (ASAT) or alanine aminotransferase (ALAT) > 2 times upper limit or hepatic disease with coagulopathy
- •Severe renal insufficiency (creatinine clearance <30ml/min)
- •Women in age of pregnancy without menopause or efficient contraception and pregnant women or breast feeding women. Men without effective contraception.
- •Any reason that makes the study participation impractical (alcohol abuse, psychosocial reason, inclusion in another study in the past month, life expectancy≤1 year...)
- •Any contraindications to study treatment (apixaban): hypersensitivity to apixaban or any of the excipients (see composition), ongoing active bleeding, hepatic disease with coagulopathy, any condition with high risk of bleeding, concomitant anticoagulant treatment.
研究组 & 干预措施
Newly diagnosed NVAF: apixaban 5 mg
blood collection for biological analyses of 30 patients new diagnosis of NVAF (VKA treatment ≤1 week) initiated with apixaban 5 mg
干预措施: Apixaban 5 mg (Drug)
Previously diagnosed NVAF: apixaban 5 mg
blood collection for biological analyses of 30 patients previously treated by VKA for more than 3 months switched to apixaban 5 mg
干预措施: Apixaban 5 mg (Drug)
结局指标
主要结局
change from baseline D-dimers level at 3 months.
时间窗: 3 months
D-dimers levels will be determined using an enzyme immunoassay (ELISA method) on citrated plasma.
次要结局
- Prothrombin time measurement, Activated partial thromboplastin time, and fibrinogen(at enrollment, at one month, and at three months)
- von Willebrand factor measurement(at enrollment, at one month, and at three months)
- Prothrombin fragment F1-F2 measurement(at enrollment, at one month, and at three months)
- Thrombin-antithrombin complex measurement(at enrollment, at one month, and at three months)
- High sensitivity CRP measurement(at enrollment, at one month, and at three months)
- AntiXa apixaban activity measurement(at enrollment, at one month, and at three months)
研究者
Dr Jean-Guillaume DILLINGER
Jean Guillaume DILLINGER, MD,PhD, principal investigator
Hopital Lariboisière