BridgeMD
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaLuate the effIcacy and safety of abeLacimab in high-risk patients with Atrial fibrillation who have been deemed unsuitable for oral antiCoagulation (LILAC)
EU CTIS ID: 2023-503224-66-00
What this study is testing
To assess whether abelacimab is superior to placebo for reducing the risk of ischemic stroke or SE in patients with AF who have been deemed unsuitable for oral anticoagulation therapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patient is able to understand and has provided written informed consent to participate in the trial
- 2. Diagnosed AF or atrial flutter (including documentation that diagnosis was based on an ECG or monitor recording, in medical history or at screening)
- 3. Age 65-74 and CHA2DS2VASc ≥4 OR age ≥75 and CHA2DS2VASc ≥3
- 4. 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 this study
- 5. At least 1 of the following: • Severe renal insufficiency (including documentation of creatinine clearance <30 mL/min by the Cockcroft-Gault formula in medical history or at screening) • Planned daily use of aspirin, a P2Y12 inhibitor, or other antiplatelet agent for the duration of the trial • History of bleeding from a critical area which includes the following (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome) or major gastrointestinal bleeding (defined as requiring hospitalization, intervention, transfusion or leading to permanent discontinuation of anticoagulation) • Other conditions associated with an increased risk of bleeding (e.g., chronic NSAID use (≥3 times per week); frailty; or history of multiple falls)
- 6. 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
You likely can't join if
- 1. AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
- 11. Patients on dialysis at screening or who are planned to start dialysis within 6 months
- 12. Use of other investigational drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- 13. History of hypersensitivity to any of the study drugs or its excipients, to drugs of similar chemical classes
- 14. Women of child-bearing potential defined as all women physiologically capable of becoming pregnant.
- 15. 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
See the full eligibility criteria
Who can join
- 1. Patient is able to understand and has provided written informed consent to participate in the trial
- 2. Diagnosed AF or atrial flutter (including documentation that diagnosis was based on an ECG or monitor recording, in medical history or at screening)
- 3. Age 65-74 and CHA2DS2VASc ≥4 OR age ≥75 and CHA2DS2VASc ≥3
- 4. 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 this study
- 5. At least 1 of the following: • Severe renal insufficiency (including documentation of creatinine clearance <30 mL/min by the Cockcroft-Gault formula in medical history or at screening) • Planned daily use of aspirin, a P2Y12 inhibitor, or other antiplatelet agent for the duration of the trial • History of bleeding from a critical area which includes the following (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome) or major gastrointestinal bleeding (defined as requiring hospitalization, intervention, transfusion or leading to permanent discontinuation of anticoagulation) • Other conditions associated with an increased risk of bleeding (e.g., chronic NSAID use (≥3 times per week); frailty; or history of multiple falls)
- 6. 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
What rules you out
- 1. AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
- 11. Patients on dialysis at screening or who are planned to start dialysis within 6 months
- 12. Use of other investigational drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- 13. History of hypersensitivity to any of the study drugs or its excipients, to drugs of similar chemical classes
- 14. Women of child-bearing potential defined as all women physiologically capable of becoming pregnant.
- 15. 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
- 2. Patients who within 60 days prior to randomization (1) received a vitamin K antagonist [(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
- 3. Patients with an intracranial or intraocular bleed within the 3 months prior to (and including) screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
- 17. Patients who are employed by the sponsor or employed by the investigator or otherwise financially dependent on them
- 4. Any stroke within 14 days before randomization or TIA within 3 days before randomization
- 5. Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
- 6. Patients with a medical condition other than AF for which chronic anticoagulation is indicated
- 7. Known presence of an atrial myxoma or left ventricular thrombus
- 8. History of or planned LAA closure or occlusion device
- 9. Clinically unstable or active endocarditis or endovascular infection
- 16. Any patients who are committed to an institution by either judicial or administrative authorities.
- 10. Planned invasive procedure with potential for uncontrolled bleeding (e.g., major surgery) within the next 3 months
The study team makes the final eligibility decision.
Where it's taking place
- Peru
- Turkey
- Canada
- India
- South Africa
- Colombia
- China
- Philippines
- Chile
- Serbia
- Argentina
- Mexico
- Korea, Republic of
- Puerto Rico
- United States
- Israel
- Japan
- Brazil
- United Kingdom
- Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peru; Turkey; Canada; India; South Africa; Colombia and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.