A multicenter, randomized, open-label, active-controlled, dose-range finding study to assess the pharmacodynamic parameters, safety and tolerability of MAA868 and its effect on thrombogenesis biomarkers compared to apixaban in patients with atrial fibrillatio

Phase 2

Withdrawn

• Conditions: 10007521; Atrial fibrillation; Atrial flutter

• Registration Number: NL-OMON46376
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>FXI-inhibition * 80% at trough (Day 91) after having received MAA868 3 times</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Objective 1:<br /><br>To evaluate the proportion of patients achieving FXI inhibition * 80% at trough<br /><br>after the first and second dose (Day 31 and Day 61) at 3 dose levels of MAA868.<br /><br><br /><br>Objective 2:<br /><br>To evaluate the incidence of major bleeding events, clinically relevant<br /><br>non-major bleeding events and total bleeding with MAA868 relative to apixaban<br /><br>during the treatment period.<br /><br><br /><br>Objective 3:<br /><br>To assess the effect of MAA868 on D-dimer and other thrombogenesis biomarkers<br /><br>as indicators of efficacy at Day 31, Day 61 and Day 91 compared to apixaban.<br /><br><br /><br>Objective 4:<br /><br>To evaluate the safety and tolerability of MAA868 compared to apixaban.</p><br>