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Anticoagulant
Dabigatran vs. Rivaroxaban for Atrial Fibrillation
N/A
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (july 1, 2010) until end of the observation period (june 30, 2016), 6 years
Awards & highlights
Summary
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (july 1, 2010) until end of the observation period (june 30, 2016), 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (july 1, 2010) until end of the observation period (june 30, 2016), 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Major Bleeding
Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
Secondary outcome measures
All-cause Mortality
Hemorrhagic Stroke
Ischemic Stroke
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dabigatran vs. RivaroxabanExperimental Treatment1 Intervention
OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC).
Group II: Dabigatran vs. ApixabanExperimental Treatment1 Intervention
OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved
Apixaban
FDA approved
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,314,993 Total Patients Enrolled
70 Trials studying Atrial Fibrillation
1,228,708 Patients Enrolled for Atrial Fibrillation
Health ResearchTx, LLC (HRTX)UNKNOWN
inVentiv Health Clinical (iVH)UNKNOWN
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