Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2020-01-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, open-label, blinded endpoint evaluation, active controlled, dose-range finding study.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

blinded (with majuscule) endpoint evaluation

Study Groups

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MAA868 low dose regimen

patients receive dose monthly.

Group Type EXPERIMENTAL

MAA868

Intervention Type DRUG

3 MAA868 doses, single administration, subcutaneous,

MAA868 middle dose regimen

patients receive dose monthly.

Group Type EXPERIMENTAL

MAA868

Intervention Type DRUG

3 MAA868 doses, single administration, subcutaneous,

MAA868 high dose regimen

patients receive dose monthly.

Group Type EXPERIMENTAL

MAA868

Intervention Type DRUG

3 MAA868 doses, single administration, subcutaneous,

Apixaban

Apixaban 5 mg b.i.d

Group Type ACTIVE_COMPARATOR

Apixaban

Intervention Type DRUG

Apixaban 5 mg b.i.d

Interventions

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MAA868

3 MAA868 doses, single administration, subcutaneous,

Intervention Type DRUG

Apixaban

Apixaban 5 mg b.i.d

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients ≥ 55 and \< 85 years old
* Body weight between 50 and 130 kg inclusive
* Atrial fibrillation or atrial flutter, as documented by electrocardiography
* CHA2DS2-VASc risk score ≥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.
* Either anticoagulant-naïve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.

Exclusion Criteria

* History of stroke, transient ischemic attack or systemic embolism
* History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months
* History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding
* Known bleeding diathesis or any known active bleeding site at screening or baseline
* Family history of bleeding disorder
* Known active GI lesions predisposing to bleeding events
* Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the screening period
* Known hemodynamically significant valvular heart disease
* Uncontrolled hypertension defined as SBP/DBP ≥ 160/100 mmHg at the screening visit
* Heart failure NYHA class IV in the 3 months prior to the screening visit
* Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (≤ 100 mg/d) is allowed but not both.
* Severe renal impairment (creatinine clearance \< 30 mL/min) at the screening visit

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No