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:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT02414035
Eligibility Criteria:
Inclusion Criteria:
1. Age\>18 y at entry
2. AF documented as follows: The patients has a symptomatic episode of paroxysmal or persistent AF documented by 12-lead ECG, rhythm strip, pacemaker/implantable cardioverter-defibrillator electrogram, or Holter ECG
3. In addition to documented AF, patients must have ≥1 CHADS2-VAS scores
4. We identified participants as those diagnosed as having AF, and who initiated dabigatran after diagnosis
5. Written, informed consent
Exclusion Criteria:
1. History of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease)
2. Severe, disabling stroke, or any stroke within the previous 14d
3. Acute coronary syndrome within 1 year in AF patients
4. Conditions associated with an increased risk of bleeding
1. Major surgery in the previous month
2. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
3. Gastrointestinal hemorrhage or hematuria
5. Severe renal impairment (estimated creatinine clearace≤30ml/min)
6. Severe liver dysfunction
7. Alcohol abuse or drug addiction
8. Patients who have received an investigational drug at this time
9. Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trail
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02414035
Study Brief:
Protocol Section:
NCT02414035