Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT03398434
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT03398434
Study Brief:
Protocol Section:
NCT03398434