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

NCT03136510 | Terminated DMC

• 1 other identifier: CV185-439
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coagulation Disorder; Non Valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• change from baseline D-dimers level at 3 months.

  D-dimers levels will be determined using an enzyme immunoassay (ELISA method) on citrated plasma.

  3 months

Secondary Outcomes (6)

• Prothrombin fragment F1-F2 measurement

  at enrollment, at one month, and at three months

• von Willebrand factor 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

• Prothrombin time measurement, Activated partial thromboplastin time, and fibrinogen

  at enrollment, at one month, and at three months

Study Arms (2)

Newly diagnosed NVAF: apixaban 5 mg

OTHER

blood collection for biological analyses of 30 patients new diagnosis of NVAF (VKA treatment ≤1 week) initiated with apixaban 5 mg

Drug: Apixaban 5 mg

Previously diagnosed NVAF: apixaban 5 mg

OTHER

blood collection for biological analyses of 30 patients previously treated by VKA for more than 3 months switched to apixaban 5 mg

Drug: Apixaban 5 mg

Interventions

Apixaban 5 mg DRUG

Bood collection for biological analyses at: * inclusion visit * follow-up visit at 1 month * end of research at 3 month

Also known as: Eliquis

Newly diagnosed NVAF: apixaban 5 mg; Previously diagnosed NVAF: apixaban 5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Hopital Lariboisière: lead

Study Sites (1)

Department of Cardiology Lariboisiere Hospital

Paris, 75010, France

Location

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

apixaban

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ludovic DROUET, MD, PhD

  Lariboisiere Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jean Guillaume DILLINGER, MD,PhD, principal investigator

Model Details: 60 patients with two subgroups * 30 patients with new diagnosis of atrial fibrillation (vitamin K antagonist treatment shorter than 1 week) : initiated with Apixaban 5 mg * 30 patients previously chronically treated by VKA for more than 3 months and switched to Apixaban 5 mg

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 2, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: July 26, 2024

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)