- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03242278
Real-world Dosing Patterns of Rivaroxaban in the United States
Real-world Dosing Patterns of Rivaroxaban in the United States (RIVA-D)
The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF) patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of rivaroxaban.
The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal function).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- NVAF (non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with International Classification of Disease ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
- Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
- CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period
- Evidence of continuous enrollment in MarketScan during 180 days before the date of the first prescription of rivaroxaban
Exclusion Criteria:
- Patients <18 years of age
- Patients with valvular AF (atrial fibrillation)
- Pregnancy
- Malignant cancers
- Transient cause of AF
- Patients with VTE (Venous thromboembolism), pulmonary embolism or DVT (Deep Vein Thrombosis)
- Patients with major surgery defined as hip or knee replacement
- Prescriptions of OACs (Oral anticoagulants) (apixaban,warfarin, dabigatran, rivaroxaban) before index date
- Prescription of more than one OAC on the index date
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
NVAF patients receiving 20 mg rivaroxaban
NVAF patients who receive a standard dose of rivaroxaban (20 mg daily)
|
As prescribed by treating physicians
|
NVAF patients receiving 15 mg rivaroxaban
NVAF patients who receive a reduced dose of rivaroxaban (15 mg daily)
|
As prescribed by treating physicians
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of NVAF patients receiving 20 mg Rivaroxaban
Time Frame: At baseline
|
At baseline
|
Number of NVAF patients receiving 15 mg Rivaroxaban
Time Frame: At baseline
|
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Baseline renal function
Time Frame: At baseline
|
At baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Bayer Study Director, Bayer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18733
- XA1511US (Other Identifier: Company internal)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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