Evaluating abelacimab for patients with atrial fibrillation unsuitable for oral anticoagulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of abelacimab compared to a placebo in high-risk patients with atrial fibrillation who are deemed unsuitable for oral anticoagulation therapy. It focuses on the rate of ischemic stroke or systemic embolism in this specific patient population. Participants must meet certain age and health criteria, including a CHA2DS2VASc score indicating a high risk for stroke. The study is designed as a randomized, double-blind, placebo-controlled trial to ensure reliable results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient is able to understand and has provided written informed consent to participate in the trial
* Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
* Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3
* Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study
* At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls
* Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study

Exclusion Criteria:

* AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
* Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
* Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
* Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
* Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
* Patients on dialysis at screening or who are planned to start dialysis within 6 months

Other protocol defined Inclusion/Exclusion criteria may apply

Where it's running

• Anthos Investigative Site 1040
  Birmingham, Alabama, United States Recruiting
• Anthos Investigational site 9939
  Birmingham, Alabama, United States Recruiting
• Anthos Investigative Site 1041
  Mobile, Alabama, United States Recruiting
• Anthos Investigative Site 1099
  Peoria, Arizona, United States Recruiting
• Anthos Investigative Site 9906
  Phoenix, Arizona, United States Recruiting
• Anthos Investigative Site 9927
  Yuma, Arizona, United States Recruiting

+739 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Anthos Therapeutics a Novartis Company
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.