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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT04593056
Eligibility Criteria:
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Eligible cohort entry dates: Market availability of rivaroxaban in the U.S. started on November 4, 2011. For Marketscan: November 4, 2011 -Dec 31, 2018 (end of data availability). For Optum: November 4, 2011 -Dec 31, 2019 (end of data availability). For Medicare: November 4, 2011 -Dec 31, 2017 (end of data availability)
Inclusion Criteria:
* 1\. Patients 18 years of age or older
* 2\. Non-valvular atrial fibrillation
* 3\. Non-valvular atrial fibrillation 14 days or after the previous diagnosis of AF in inclusion 2
* 4\. History of prior ischemic stroke, TIA, systemic embolism or two or more of the following risk factors:
* 4a. Heart failure and/or left ventricular ejection fraction ≤35%
* 4b. Hypertension (defined as use of antihypertensive medications within 6 months before the screening visit or persistent systolic blood pressure above 140 mmHg or diastolic blood pressure above 90 mmHg)
* 4c. Patients 75 years of age or older
* 4d. Diabetes mellitus (defined as a history of type 1 or type 2 diabetes mellitus or use of antidiabetic medications within 6 months before screening visit)
Exclusion Criteria:
* 1\. Cardiac-related conditions
* 1a. Hemodynamically significant mitral valve stenosis
* 1b. Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted)
* 1e. Known presence of atrial myxoma or left ventricular thrombus
* 1f. Active endocarditis
* 2\. Hemorrhage-related risk criteria
* 2a. Active internal bleeding
* 2b. History of or condition associated with increased bleeding risk including, but not limited to:
* Major surgical procedure or trauma within 30 days before the randomization visit
* Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
* History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
* Chronic hemorrhagic disorder
* Known intracranial neoplasm, arteriovenous malformation, or aneurysm
* 2d. Platelet count \< \<90,000/μL at the screening visit
* 2e. Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100
* 3\. Concomitant conditions and therapies
* 3a. Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months or any stroke within 14 days before the randomization visit
* 3b. Transient ischemic attack within 3 days before the randomization visit
* 3c. Indication for anticoagulant therapy for a condition other than atrial fibrillation (e.g., VTE)
* 3d. Treatment with:
* Aspirin \>100 mg daily
* Aspirin in combination with thienopyridines within 5 days before randomization
* Intravenous antiplatelets within 5 days before randomization
* Fibrinolytics within 10 days before randomization
* Note: Aspirin ≤100 mg monotherapy is allowed and thienopyridine monotherapy is allowed.
* 3f. Systemic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors, within 4 days before randomization, or planned treatment during the time period of the study
* 3g. Treatment with a strong inducer of cytochrome P450 3A4, such as rifampin/rifampicin, within 4 days before randomization, or planned treatment during the time period of the study
* 3h. Anemia (hemoglobin \<10 g/dL) at the screening visit
* 3i. Pregnancy or breast-feeding
* 3k. Known HIV infection at time of screening
* 3l. Calculated CLCR \<30 mL/min at the screening visit (refer to Attachment 4 for calculating CLCR)
* 3m. Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or ALT \>3 x the ULN
* 4\. Study participation and follow-up-related criteria
* 4a. Serious concomitant illness associated with a life expectancy of less than 2 years
* 4b. Drug addiction or alcohol abuse within 3 years before the randomization visit
* 4f. Inability or unwillingness to comply with study-related procedures
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04593056
Study Brief:
Protocol Section:
NCT04593056