Apixaban Versus Rivaroxaban in Non Valvular Atrial Fibrillation

NCT06862726 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: Apixa Xa
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will first measure the maximum concentration (after 2 hours of intake) and the residual concentration (just before the next intake) after at least 15 consecutive days of treatment. In order to be able to study the stability of the anti-Xa activity of Apixaban vs Rivaroxaban, as well as their impact on the risk of thromboembolic events or hemorrhagic events, clinical follow-up and a determination of maximum and residual activity are necessary, ideally at 3 to 6 months (compared to studies carried out in the literature). This evaluation would be made according to a multivariate analysis taking into consideration the other clinical-biological data relating to the patient, namely renal function, liver function, CHA2DS2-VASc score, HAS-BLEED score, treatment compliance, etc.

Conditions

Non Valvular Atrial Fibrillation

Keywords

non valvular atrial fibrillation; Direct oral anticoagulant; thromboembolic events; hemorrhage; anti-FXa activity; variability

Outcome Measures

Primary Outcomes (1)

• To compare the variability of anti-FXa activity of apixaban versus rivaroxaban

  The patient will attend an initial appointment between 2 and 4 weeks to undergo sampling and receive their samples, followed by further appointments at 3 and 6 months. During these visits, samples will be collected to measure the anti-Xa activity of rivaroxaban and apixaban. Each sampling will occur in two steps: the first sample will be taken before the morning dose to measure anti-Xa activity at the trough (or nadir), and the second sample will be collected 2 hours later to determine the peak (or maximum value reached). The results will be expressed in nanograms per milliliter (ng/mL).

  6 months

Study Arms (3)

VKA

ACTIVE COMPARATOR

This arm contain 40 patients on anti-vitamin K. Their prothromin level and INR will be measured

Drug: Dosage of PT-INR

Apixaban

ACTIVE COMPARATOR

This arm contain 40 patients. Anti Xa activity and Time in the range will be monitored

Drug: Anti Xa dosage

Rivaroxaban

ACTIVE COMPARATOR

This arm contain 40 patients. Anti Xa activity and Time in the range will be monitored

Drug: Anti Xa dosage

Interventions

Anti Xa dosage DRUG

VKA: quadriseparable tablet Apixaban: 5 mg twice daily or 2.5 twice daily Rivaroxaban: 20 mg once a day or 15 mg once a day

Apixaban; Rivaroxaban

Dosage of PT-INR DRUG

This arm contain 40 pateints treated by VKA,. PT-INR dosage will be performed.

VKA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age
• Patients diagnosed with AF;
• Written informed consent obtained prior to participation in the study.

You may not qualify if:

• Patients with at least one of the following criteria will not be included in the trial:
• History of hypersensitivity to study drugs or drugs with a similar chemical structure.
• Patients receiving combination therapy of P-glycoprotein inhibitors or inducers such as itraconazole, ketoconazole, voriconazole, posaconazole, ritonavir, rifampicin, phenytoin, phenobarbital, and carbamazepine, within 14 days prior to taking apixaban
• Pregnant women
• Breastfeeding
• Patients Enrolled in Other Clinical Studies
• Patients who refuse to sign consent.

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead

Study Sites (1)

Charles Nicolle hospital

Tunis, 1006, Tunisia

Location

Related Publications (2)

• Mavri A, Vene N, Bozic-Mijovski M, Miklic M, Soderblom L, Pohanka A, Malmstrom RE, Antovic J. Apixaban concentration variability and relation to clinical outcomes in real-life patients with atrial fibrillation. Sci Rep. 2021 Jul 6;11(1):13908. doi: 10.1038/s41598-021-93372-9.

  PMID: 34230559 RESULT

• Katritsis DG, Gersh BJ, Camm AJ. Anticoagulation in Atrial Fibrillation - Current Concepts. Arrhythm Electrophysiol Rev. 2015 Aug;4(2):100-7. doi: 10.15420/aer.2015.04.02.100.

  PMID: 26835109 RESULT

MeSH Terms

Conditions

Thromboembolism; Hemorrhage

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: March 6, 2025
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Locations

TU (1)