NCT06862726Enrolling by invitationPhase 4
Apixaban Versus Rivaroxaban in Non Valvular Atrial Fibrillation
Study of the Inter- and Intra-individual Variability of Anti-Xa Activity of Apixaban Versus Rivaroxaban Versus Control Arm During Non-valvular Atrial Fibrillation: Evaluation of Stability and Clinical Impact
Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Diseases
- Atrial fibrillation
- NCT number
- NCT06862726
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 1 Dec 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of hypersensitivity to study drugs or drugs with a similar chemical structure.
Other
- Patients with at least one of the following criteria will not be included in the trial:
- Pregnant women
- Breastfeeding
- Patients Enrolled in Other Clinical Studies
- Patients who refuse to sign consent.
Who the study is looking for
- Male or female ≥ 18 years of age
- Patients diagnosed with AF;
- Written informed consent obtained prior to participation in the study.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charles Nicolle hospital Coordinator of this site? Confirm its status | Tunis | Tunisia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.