Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrill… (NCT07739888) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation
2,500 participantsStarted 2027-12-30
Plain-language summary
This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302 (ANT-010/NCT05712200)
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients are able to provide written informed consent to enter the extension part.
* Patients must be on study treatment at the time of EoT visit in the core part.
Exclusion Criteria:
* Patients meeting any exclusion criteria in the core part.
* Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation
* History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes
* Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention/hospitalization or may preclude patients from complying with study requirements for the duration of the study.
Other protocol defined Inclusion/Exclusion criteria may apply
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to first ISTH major Bleeding events
Timeframe: Up to 3 years
2
Time to first BARC type 3c/5 bleeding
Timeframe: Up to 3 years
3
Number of participants with ISTH major or CRNM bleeding
Timeframe: Up to 3 years
4
Number of participants with bleeding
Timeframe: Up to 3 years
5
Number of participants with TEAEs and TESAEs
Timeframe: Up to 3 years
6
Number of participants with treatment discontinuations due to TEAEs
Timeframe: Up to 3 years
7
Number of participants with device related AEs, SAEs, and device deficiencies