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A study to compare how safe and well tolerated study drug Abelacimab (MAA868) is compared to another drug called Rivaroxaban in patients with heart condition that causes an irregular and abnormally fast heart rate
EU CTIS ID: 2023-509066-38-00
What this study is testing
To evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events
- Therapeutic exploratory (Phase II)
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
- Able to provide written informed consent before the first study assessment is performed.
- Male and female patients ≥ 55 years old.
- History of AF or atrial flutter with planned indefinite anticoagulation. Patients with newly diagnosed AF are eligible.
- A CHA2DS2-VASc of ≥4 OR a CHA2DS2-VASc of ≥3 with at least 1 of the following: • Planned concomitant use of antiplatelet medication (e.g. aspirin and/or P2Y12 inhibitor) for the duration of the trial. • CrCl ≤50 ml/min by the Cockcroft-Gault equation.
- Extension period inclusion criteria: Ongoing study treatment for the randomized part of the trial at the EoT visit.
- Extension period inclusion criteria: Able to provide written informed consent to enter the extension period.
You likely can't join if
- 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.
- Planned invasive procedure with potential for uncontrolled bleeding (e.g. major surgery).
- Any stroke within 14 days before randomization or TIA within 3 days before randomization.
- A CrCl <15 mL/min or on dialysis at the time of Screening.
- Platelet count ≤70,000/mm3 at the Screening Visit.
- Hemoglobin <8 g/dL at the Screening Visit.
See the full eligibility criteria
Who can join
- Able to provide written informed consent before the first study assessment is performed.
- Male and female patients ≥ 55 years old.
- History of AF or atrial flutter with planned indefinite anticoagulation. Patients with newly diagnosed AF are eligible.
- A CHA2DS2-VASc of ≥4 OR a CHA2DS2-VASc of ≥3 with at least 1 of the following: • Planned concomitant use of antiplatelet medication (e.g. aspirin and/or P2Y12 inhibitor) for the duration of the trial. • CrCl ≤50 ml/min by the Cockcroft-Gault equation.
- Extension period inclusion criteria: Ongoing study treatment for the randomized part of the trial at the EoT visit.
- Extension period inclusion criteria: Able to provide written informed consent to enter the extension period.
What rules you out
- 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.
- Planned invasive procedure with potential for uncontrolled bleeding (e.g. major surgery).
- Any stroke within 14 days before randomization or TIA within 3 days before randomization.
- A CrCl <15 mL/min or on dialysis at the time of Screening.
- Platelet count ≤70,000/mm3 at the Screening Visit.
- Hemoglobin <8 g/dL at the Screening Visit.
- aPTT or PT >1.5x the upper limit of normal (ULN) at the Screening Visit, if the patient is anticoagulant-naïve.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception during their participation in the trial and for at least 10 weeks after the last dose of abelacimab for women randomized to abelacimab. Highly effective contraception methods include: • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment • Male sterilization of sexual partner (at least 6 months prior to screening). For female patients in the study, the vasectomized male partner should be the sole partner for that patient • Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. Hormonal contraceptive methods should not be used or encouraged if considered to be contraindicated. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of reported menopausal status or oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment with follicle stimulating hormone (FSH) is she considered not of child-bearing potential.
- Sexually active males with female partners who are WOCBP must agree to use a condomor use other reliable birth control methods during their time in the study and should notfather a child or donate sperm during the study period.
- History of drug addiction or alcohol abuse in the past 2 years, as judged by the Investigator.
- Significant illness which has not resolved within two (2) weeks prior to the start of the study drug.
- History of hypersensitivity to any of the study drugs (including rivaroxaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for rivaroxaban.
- Any medical or psychiatric condition which in the judgment of the Investigator may preclude patients of complying with study requirements for the duration of the study.
- Extension period exclusion criteria: History of hypersensitivity to abelacimab.
- Extension period exclusion criteria: Patients with an intracranial or intraocular bleed within the 3 months prior to EoT.
- Extension period exclusion criteria: Clinically significant mitral stenosis (valve area <1.5 cm2) Mechanical heart valve or other indication for anticoagulation therapy other than atrial fibrillation (e.g., venous thromboembolism).
- Extension period exclusion criteria: Known presence of an atrial myxoma or left ventricular thrombus.
- Extension period exclusion criteria: History of left atrial appendage closure or removal.
- Patients with an intracranial or intraocular bleed within the 3 months prior to screening.
- Clinically significant mitral stenosis (valve area <1.5 cm2).
- Mechanical heart valve or other indication for anticoagulation therapy other than atrial fibrillation (e.g., venous thromboembolism).
- Known presence of an atrial myxoma or left ventricular thrombus.
- History of left atrial appendage closure or removal.
- Active endocarditis.
- Systolic BP >180 mm Hg or diastolic BP >100 mm Hg on repeated measurements at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Taiwan
- Korea, Republic of
- United States
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Taiwan; Korea, Republic of; United States. 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.