Health TrialsbyHealthPanel

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

ConditionAtrial Fibrillation (AF)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation.

The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.

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

* What side effects may happen from taking REGN7508 or REGN9933 * How well do the study drugs reduce the risk of having a stroke * How much of REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs 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 felt 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 Thromboembolism (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 successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol

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

  • REGN9933

    Drug

    Administered per the protocol

  • Apixaban

    Drug

    Administered per the protocol

Treatment groups

1,200 Participants
are divided into 3 treatment groups
Group A: REGN7508Experimental treatment 1 intervention
Group B: REGN9933Experimental treatment 1 intervention
Group C: ApixabanActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of any bleeding

Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding

Time frame
12 weeks

Secondary outcomes

1

Incidence of the composite of ISTH major bleeding or ISTH CRNM bleeding

Time frame
12 weeks
2

Incidence of ISTH major bleeding

Time frame
12 weeks
3

Incidence of ISTH CRNM bleeding

Time frame
12 weeks
4

Incidence of minor bleeding

Time frame
12 weeks

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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