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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

ConditionAtrial Fibrillation (AF)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly.

The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol

CHA2DS2-VA [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years] score ≥2 and Oral Anticoagulant (OAC) naïve OR

CHA2DS2-VA score ≥3 OR

CHA2DS2-VA score of 2 AND at least 1 enrichment criteria as described in the protocol

Disqualifiers

Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)

Has known moderate-to-severe mitral stenosis

Has had a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization

Had an ischemic stroke within 2 days prior to randomization

Trial design

Design model

Parallel

Treatments tested in this trial

  • REGN7508

    Drug

    Administered per the protocol

  • Apixaban

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

15,364 Participants
are divided into 2 treatment groups
Group A: REGN7508 + PlaceboExperimental treatment 2 interventions
Group B: Apixaban + PlaceboActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism

Time frame
Approximately 36 months
2

Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding

Time frame
Approximately 36 months

Secondary outcomes

1

Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding

Time frame
Approximately 36 months
2

Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding

Time frame
Approximately 36 months
3

Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death

Time frame
Approximately 36 months
4

Time to first occurrence of ISTH major bleeding

Time frame
Approximately 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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