A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: MAA868 Cohort 1; MAA868 Cohort 2; MAA868 Cohort 3; Placebo
Intervention description: Subcutaneous injection: low dose; Subcutaneous injection: high dose; Subcutaneous injection: Dose to be determined.; Subcutaneous injection: Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: atrial fibrillation; flutter; paroxysmal atrial fibrillation; stroke; cardiac arrhythmia

Summary:

      This study is a multicenter, randomized, subject and Investigator-blinded,
      placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the
      safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in
      patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or
      peripheral embolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients ≥ 18 and < 85 years old with paroxysmal atrial fibrillation
             (PAF) or atrial flutter on 12 lead electrocardiography at Screening Or

          -  Patients with a history of PAF or atrial flutter, as documented by (telemetry, 12 lead
             electrocardiography or ambulatory [e.g. Holter] monitor) and not due to a reversible
             condition (e.g. alcohol binge drinking) can be entered even if they do not have PAF at
             Screening. There is not time-limit for this.

          -  Patients with a Congestive heart failure, Hypertension, Age ( > 65 = 1 point, > 75 = 2
             points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc)
             risk score (tool as a predictor for estimating the risk of stroke in patients with
             atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in
             whom, in the investigator's judgment, the use of an anticoagulant for stroke
             prevention is not indicated

        Exclusion Criteria:

          -  History of stroke, transient ischemic attack or systemic embolism

          -  History of major bleeding during treatment with an anticoagulant or antiplatelet
             therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet
             therapy more than a year ago can be enrolled only if the bleeding was due to a
             reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.)

          -  History of traumatic or non-traumatic intracranial, intraspinal or intraocular
             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 clinically significant valvular heart disease including moderate or severe
             mitral stenosis (valve area <1.5 cm2)

          -  Patients with a prosthetic heart valve

        Other protocol defined Inclusion/Exclusion criteria may apply