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 @ 5:15 PM
Ignite Modification Date:
2025-12-24 @ 5:15 PM
NCT ID:
NCT01884350
Eligibility Criteria:
Inclusion Criteria:
1. Patients with diagnosed non-valvular Atrial Fibrillation (AF) or atrial flutter (documented by 12-lead electrocardiogram (ECG) or Holter recording) and eligible for oral anticoagulant (OAC) therapy
2. Presence of at least one of the following risk factors for stroke:
Prior stroke or transient ischaemic attack (TIA)
* Age ≥75 years
* Hypertension
* Diabetes mellitus
* Symptomatic heart failure \[New York Heart Association (NYHA) Class ≥II\]
3. Must be able to self-administer treatment
4. Either Vitamin K antagonists (VKA) treated or VKA naive. Patients treated with VKA should have received the VKA treatment for ≥3 months. VKA naïve patients should not have received VKA treatment for more than 30 days within the last 12 months. Patients who are not described by either of the above criteria are not eligible for the study
5. Patients previously treated with acetylsalicylic acid (ASA) for stroke prevention are allowed (and will switch to Apixaban)
6. Patients with screening mini-mental state examination (MMSE) more than 24
7. Subject Re-enrollment: This study does not permit the re-enrollment of a subject that has discontinued the study as a pre-treatment failure
Age and Reproductive Status:
* i) Men and women ≥18 years of age
* ii) Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in protocol. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication
* iv) Women must not be breastfeeding
* v) Men who are sexually active with women of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year
* vi) Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile); and azoospermic men do not require contraception
Exclusion Criteria:
1. Target Disease Exceptions:
1. Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
2. Clinically significant (moderate or severe) mitral stenosis
3. Cardiac valvular disease requiring surgery
4. Planned major surgery or/and invasive procedure and/or atrial fibrillation or flutter, ablation procedure and/or cardioversion
5. Patients receiving Rivaroxaban, Dabigatran or Apixaban
2. Medical History and Concurrent Diseases:
1. Conditions other than atrial fibrillation that require chronic anticoagulation (e.g., prosthetic mechanical heart valve, venous thromboembolism; also see Section 3.4, Concomitant Treatments)
2. Patient with serious bleeding in the last 6 months or with a lesion or condition at high risk of bleeding such as:
* Active peptic ulcer disease, current or recent gastrointestinal ulceration
* Known or suspected esophageal varices
* Recent ischemic stroke (within 7 days)
* Recent brain or spinal injury or intracranial hemorrhage
* Recent brain, spinal or ophthalmic surgery
* Arteriovenous malformations
* Vascular aneurysms
* Major intraspinal or intracerebral vascular abnormalities
* Documented hemorrhagic tendencies or blood dyscrasias
* Presence of malignant neoplasms at high risk of bleeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01884350
Study Brief:
Protocol Section:
NCT01884350