Trial · NCT04755283
Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation
NCT04755283, Phase 2, Active not recruiting, Anthos Therapeutics, Inc.; results first posted 2025-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation. Trials, record NCT04755283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04755283
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation
- NCT number
- NCT04755283
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 1,287 participants, actual
- Lead sponsor
- Anthos Therapeutics, Inc.
- Conditions
- Atrial Fibrillation (AF), Stroke
- Interventions
- Abelacimab, Rivaroxaban
- First posted
- 2021-02-16
- Last updated
- 2025-11-06
- Other registries' IDs
- eudract:2020-004507-13
- Results first posted
- 2025-07-30
- Limitations and caveats
- The independent data monitoring committee recommended early termination of the trial on September 14, 2023.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events | Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months. | The number of participants experiencing the first occurrence of the composite of ISTH-defined major bleeding or CRNM bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase. |
| Secondary | Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events | Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months. | The number of participants experiencing the first occurrence of ISTH-defined major bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase. |
| Secondary | Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events | Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months. | The number of participants experiencing the first occurrence of the composite of ISTH-defined major or CRNM or minor bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events | Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months. | The analysis population is the number of randomized participants who received at least one dose of study treatment. The difference between the overall number of participants analyzed and the overall number of participants assigned to the arm represents those who never received a dose of study treatment. | participants with event/100 person-years | NUMBER |
| SECONDARY | Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events | Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months. | The analysis population is the number of randomized participants who received at least one dose of study treatment. The difference between the overall number of participants analyzed and the overall number of participants assigned to the arm represents those who never received a dose of study treatment. | participants with event/100 person-years | NUMBER |
| SECONDARY | Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events | Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months. | The analysis population is the number of randomized participants who received at least one dose of study treatment. The difference between the overall number of participants analyzed and the overall number of participants assigned to the arm represents those who never received a dose of study treatment. | participants with event/100 person-years | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events | Abelacimab 90 mg (MAA868) | 2.64 | participants with event/100 person-years | ||
| Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events | Abelacimab 150 mg (MAA868) | 3.22 | participants with event/100 person-years | ||
| Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events | Rivaroxaban | 8.39 | participants with event/100 person-years | ||
| Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events | Abelacimab 90 mg (MAA868) | 0.99 | participants with event/100 person-years | ||
| Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events | Abelacimab 150 mg (MAA868) | 1.22 | participants with event/100 person-years | ||
| Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events | Rivaroxaban | 3.73 | participants with event/100 person-years | ||
| Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events | Abelacimab 90 mg (MAA868) | 7.05 | participants with event/100 person-years | ||
| Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events | Abelacimab 150 mg (MAA868) | 10.43 | participants with event/100 person-years | ||
| Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events | Rivaroxaban | 15.30 | participants with event/100 person-years |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abelacimab 90 mg (MAA868) | 427 | |
| Overall Study | STARTED | Abelacimab 150 mg (MAA868) | 430 | |
| Overall Study | STARTED | Rivaroxaban | 430 | |
| Overall Study | Entered Open-Label | Abelacimab 90 mg (MAA868) | 250 | |
| Overall Study | Entered Open-Label | Abelacimab 150 mg (MAA868) | 240 | |
| Overall Study | Entered Open-Label | Rivaroxaban | 215 | |
| Overall Study | COMPLETED | Abelacimab 90 mg (MAA868) | 382 | |
| Overall Study | COMPLETED | Abelacimab 150 mg (MAA868) | 391 | |
| Overall Study | COMPLETED | Rivaroxaban | 389 | |
| Overall Study | NOT COMPLETED | Abelacimab 90 mg (MAA868) | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,038
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Abelacimab 90 mg (MAA868) | 41 | 425 | 42 |
| other | COVID-19 | Infections and infestations | Abelacimab 150 mg (MAA868) | 48 | 427 | 49 |
| other | COVID-19 | Infections and infestations | Rivaroxaban | 45 | 428 | 46 |
| other | Atrial fibrillation | Cardiac disorders | Abelacimab 90 mg (MAA868) | 28 | 425 | 39 |
| other | Atrial fibrillation | Cardiac disorders | Abelacimab 150 mg (MAA868) | 27 | 427 | 34 |
| other | Atrial fibrillation | Cardiac disorders | Rivaroxaban | 24 | 428 | 31 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Abelacimab 90 mg (MAA868) | 23 | 425 | 26 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Abelacimab 150 mg (MAA868) | 26 | 427 | 31 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Rivaroxaban | 27 | 428 | 29 |
| other | Hypertension | Vascular disorders | Abelacimab 90 mg (MAA868) | 24 | 425 | 25 |
1 to 10 of 1,038Source ClinicalTrials.gov
See all 1,038 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abelacimab 90 mg (MAA868) | 31 | 427 |
| Total, all-cause mortality | Abelacimab 150 mg (MAA868) | 36 | 430 |
| Total, all-cause mortality | Rivaroxaban | 34 | 430 |
| Total, other adverse events | Abelacimab 90 mg (MAA868) | 215 | 425 |
| Total, other adverse events | Abelacimab 150 mg (MAA868) | 257 | 427 |
| Total, other adverse events | Rivaroxaban | 227 | 428 |
| Total, serious adverse events | Abelacimab 90 mg (MAA868) | 158 | 425 |
| Total, serious adverse events | Abelacimab 150 mg (MAA868) | 157 | 427 |
| Total, serious adverse events | Rivaroxaban | 167 | 428 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04755283
GET https://conductscience.org/api/trials/v1/NCT04755283/events?page=2