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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT00911300
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged at least 18 years with atrial fibrillation (AF) meeting at least one of the following criteria (a, b, c): a. Acute clinical symptoms (like palpitations, chest pain, dyspnea, fatigue, lightheadedness, or syncope) for at least 48 hours and AF on baseline ECG b. Newly discovered AF persisting for \>=7 days c. Recurrent AF persisting for \>=7 days
Exclusion Criteria:
* No documented sinus rhythm on ECG for more than 1 year
* Acute neurological deficits (TIA, stroke, intracranial bleeding), or known disease which may cause neurological deficits (e.g., multiple sclerosis, seizure disorder)
* Treatment with antithrombotic agents, including low-dose anticoagulation, for more than 48 hours prior to randomisation
* Treatment with oral NSAIDs or ASA at doses greater than 325 mg per day for more than 72 hours prior to randomisation
* Anticoagulant therapy required or likely to be required during the study period
* Treatment with ASA at a dose greater than 325 mg per day or oral NSAIDs (at any dose) required or likely to be required during the study period
* Treatment with two or more antiplatelet agents (e.g. clopidogrel and ASA) at any dose at the same time (i.e., within 24 hours)
* Known hypersensitivity to UFH, VKA, or Fondaparinux or one of these drugs' excipients
* Active, clinically significant bleeding or clinically significant bleeding within the past month
* Major surgery within the previous three months
* Uncontrolled arterial hypertension (persistent systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg)
* Bacterial endocarditis
* Calculated creatinine clearance \< 30 mL/min
* Body weight \< 50 kg
* Planned surgery or intervention within the next 65 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00911300
Study Brief:
Protocol Section:
NCT00911300