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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01352702
Eligibility Criteria:
Key Inclusion Criteria:
* Patients with atrial fibrillation and an indication for oral anticoagulation (CHA2DS2-VASc score≥ 1).
* Current clopidogrel treatment
* Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
Key Exclusion Criteria:
* Age ≤18 years
* Cardiogenic shock
* Current therapy with dabigatran
* Patients with a recent thromboembolic event and high thromboembolic risk requiring bridging therapy with either unfractionated heparin or LMWH
* Contraindication for oral anticoagulation
* Active bleeding
* Known allergy or intolerance to the study medications: dabigatran, phenprocoumon
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01352702
Study Brief:
Protocol Section:
NCT01352702