- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570047
Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation (CER3)
SAFETY AND EFFECTIVENESS EVALUATION OF PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION TREATED WITH OACS: COMPARISON BETWEEN NOACS AND WARFARIN (CER3)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tokyo, Japan
- Pfizer Japan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria
Patients must meet all of the following criteria to be eligible for the study:
- Diagnosed with AF anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
- Prescribed one of the index OACs (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
- No use of the any OACs during the baseline period (the 180 days before the index date)
- Age of 18 years or older on the index date.
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study:
1. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period 2. Having a cardiac surgery procedure record during the baseline period 3. Having a joint replacement procedure record during the baseline period 4. Having a procedure of prosthetic heart valve during the baseline period 5. Having a diagnosis of venous thromboembolism during the baseline period 6. Female patients with pregnancy during the follow-up period 7. Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.
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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of stroke and systemic embolism events after index date was reported.
Stroke events included the composite of any ischemic and any hemorrhagic stroke events (non-traumatic extradural hemorrhage).
Systemic embolism events were defined as any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis.
Index date was defined as date of first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
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During the observation period of approximately 7 years
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Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of major bleeding event after index date was reported.
Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed in International Statistical Classification of Diseases and Related Health Problems (ICD)-10 diagnosis code.
An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
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During the observation period of approximately 7 years
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Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of any bleeding event after index date was reported.
Any bleeding was defined using ICD-10 diagnosis codes and participants were considered to have "any bleeding" if pre-defined bleeding-associated ICD-10 diagnosis codes appeared in the records.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
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During the observation period of approximately 7 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of ischemic stroke after index date was reported.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
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During the observation period of approximately 7 years
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Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of hemorrhagic stroke after index date was reported.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
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During the observation period of approximately 7 years
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Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of systemic embolism events after index date was reported.
Systemic embolism events included any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
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During the observation period of approximately 7 years
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Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of major gastrointestinal bleeding events after index date was reported.
Major gastrointestinal bleeding after index date was identified using hospital claims which had a gastrointestinal bleeding diagnosis code as the first listed ICD-10 diagnosis code.
An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
|
During the observation period of approximately 7 years
|
Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of any gastrointestinal bleeding event after index date was reported.
Any gastrointestinal bleeding was defined by ICD-10 diagnosis codes.
If participants had ICD-10 diagnosis codes which suggest bleeding from the gastrointestinal tract, they were considered to have any gastrointestinal bleeding.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
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During the observation period of approximately 7 years
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Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of major intracranial hemorrhage events after index date was reported.
Major intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have "major intracranial hemorrhage" if pre-defined major intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
|
During the observation period of approximately 7 years
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Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date
Time Frame: During the observation period of approximately 7 years
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Event rate per 100 participant-years for first occurrence of any intracranial hemorrhage event after index date was reported.
Any intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have "any intracranial hemorrhagic event" if pre-defined any intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records.
Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017).
Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
|
During the observation period of approximately 7 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
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
- B0661120
- CER3 (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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