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ORIGINAL RESEARCH article

Front. Pharmacol.

Sec. Drugs Outcomes Research and Policies

Volume 16 - 2025 | doi: 10.3389/fphar.2025.1565094

Safety and effectiveness of apixaban use for stroke prevention during Ramadan fasting (The API-Ram Study)

Provisionally accepted
Aiman  GhrabAiman Ghrab1*Rania  GargouriRania Gargouri1*faouzi  addadfaouzi addad2anis  cheikhrouhouanis cheikhrouhou1mariem  jabeurmariem jabeur1Salma  CharfeddineSalma Charfeddine1AMINE  BAHLOULAMINE BAHLOUL1Zied  TrikiZied Triki1Tarek  EllouzeTarek Ellouze1Omar  AbidiOmar Abidi2Souad  MallekSouad Mallek1Faten  TrikiFaten Triki1Salem  ABDESSALEMSalem ABDESSALEM3ismail  elalamyismail elalamy4Leila  AbidLeila Abid1*
  • 1Hopital Universitaire Hedi Chaker, Sfax, Tunisia
  • 2Hannibal Clinic, Tunis, Tunisia
  • 3Clinic Pasteur, Tunis, Tunisia
  • 4Service d'Hématologie Biologique, Hôpital Tenon, Paris, France

The final, formatted version of the article will be published soon.

Patients receiving anticoagulation for atrial fibrillation (AF) are required to consult their doctor before starting Ramadan to get his authorization for fasting and adapt their treatment. More often, a once daily regimen is proposed to facilitate their intake schedule. Apixaban, a direct oral anticoagulant, prescribed twice daily with an optimal benefit/risk ratio in numerous situations, has very limited data on its use during Ramadan.To evaluate the safety and the efficacy of apixaban for stroke prevention in AF patients during the month of Ramadan.Methods: An observational, multicentric study was performed in Tunisia during two consecutive years during the specific month of Ramadan. The API-Ram study included AF patients who were on apixaban and fasted at least 10 days. Efficacy was defined by the absence of ischemic events and safety was established with bleeding events occurrence classified via the BARC classification during the study period.Results: A total of 257 patients were included in our study. No ischemic events were reported during the study period. Minor bleeding events were reported in only 12 patients (4.7%) with not any major bleeding event. Based on multivariate analysis, independent predictors for bleeding risk of our population were smoking, history of hypertension and creatinine clearance.Apixaban seems to be safe and effective for the prevention of thromboembolic episode in AF patients during Ramadan fasting. Larger studies such as randomized clinical trials are necessary to confirm these results.

Keywords: apixaban, Atrial Fibrillation, Ramadan fasting, Stroke, Anticoagulants

Received: 04 Mar 2025; Accepted: 18 Jul 2025.

Copyright: © 2025 Ghrab, Gargouri, addad, cheikhrouhou, jabeur, Charfeddine, BAHLOUL, Triki, Ellouze, Abidi, Mallek, Triki, ABDESSALEM, elalamy and Abid. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Aiman Ghrab, Hopital Universitaire Hedi Chaker, Sfax, Tunisia
Rania Gargouri, Hopital Universitaire Hedi Chaker, Sfax, Tunisia
Leila Abid, Hopital Universitaire Hedi Chaker, Sfax, Tunisia

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