N/A
N=103,101
Anticoagulants Comparative Benefit-risk Ratio in Real Life
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02785354 ↗Enrolled (actual)
103,101
Serious AEs
—
Results posted
Nov 2018
Primary outcome: Primary: Clinically Relevant Bleeding — 367; 668; 635; 767 participants with event — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Relevant Bleeding |
367; 668; 635; 767 | <0.0001 sig |
| PRIMARY Major Bleeding |
178; 341; 280; 417 | <0.0001 sig |
| PRIMARY Arterial Thrombotic Event |
226; 321; 343; 351 | 0.0007 sig |
| PRIMARY Acute Coronary Syndrome |
176; 238; 230; 277 | 0.0147 sig |
| PRIMARY Death (All-cause) |
686; 983; 908; 1186 | <0.0001 sig |
| PRIMARY Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death) |
1340; 1970; 1967; 2328 | <0.0001 sig |
Summary
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.
The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013
Eligibility Criteria
Inclusion criteria
Patients with NVAF with a first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA in 2013, with no other identified indication for anticoagulation; Without any VKA or NOAC (Pradaxa®, Xarelto®, or Eliquis®) reimbursed dispensation for the last 3 years before the first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA
Exclusion criteria
None
Data sourced from ClinicalTrials.gov (NCT02785354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.