Evolution of Coagulation Activity in Non Valvular Atrial Fibrillation Patients Under Apixaban

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hopital Lariboisière
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.