N/A
Completed N=5,982
Comparative Effectiveness of Oral Anticoagulants
Source: ClinicalTrials.gov NCT01847547 ↗Enrolled (actual)
5,982
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Incidence Rate of Stroke — 29.09; 31.59 events per 1000 person years
Summary
This cohort study plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Stroke |
29.09; 31.59 | — |
| PRIMARY Incidence Rate of Major Bleeding |
60.00; 66.72 | — |
| SECONDARY Incidence Rate of Myocardial Infarction |
16.90; 14.73 | — |
| SECONDARY Incidence Rate of Venous Thromboembolism |
8.83; 34.79 | — |
| SECONDARY Incidence Rate of Deep Vein Thrombosis |
7.23; 27.35 | — |
| SECONDARY Incidence Rate of Pulmonary Embolism |
3.21; 13.65 | — |
| SECONDARY Incidence Rate of Major Lower Gastrointestinal Bleeding |
35.52; 30.57 | — |
| SECONDARY Incidence Rate of Major Urogenital Bleeding |
0.0; 0.0 | — |
| SECONDARY Incidence Rate of Major Other Bleeding |
32.25; 46.41 | — |
| SECONDARY Incidence Rate of Transient Ischemic Attack |
11.27; 12.61 | — |
| SECONDARY Incidence Rate of Major Upper Gastrointestinal Bleeding |
4.82; 7.34 | — |
| SECONDARY Incidence Rate of Stroke or Systemic Embolism |
39.73; 60.38 | — |
| SECONDARY Incidence Rate of Systemic Embolism |
11.27; 30.55 | — |
| SECONDARY Incidence Rate of Ischemic Stroke |
27.40; 32.71 | — |
| SECONDARY Incidence Rate of Hemorrhagic Stroke |
4.02; 3.14 | — |
| SECONDARY Incidence Rate of Stroke Uncertain Classification |
20.98; 14.70 | — |
| SECONDARY Incidence Rate of Major Intracranial Bleeding |
9.65; 7.34 | — |
| SECONDARY Incidence Rate of Major Extracranial Bleeding |
56.70; 63.53 | — |
| SECONDARY Incidence Rate of Major Gastrointestinal Bleeding |
37.14; 31.63 | — |
Eligibility Criteria
Inclusion criteria
- A recorded diagnosis of atrial fibrillation (AF).
- Initiation of anticoagulant medication (dabigatran or warfarin).
- At least 18 years of age on the date of anticoagulant initiation CHA2DS2-VASc-Score >=1
Exclusion criteria
- Patients with missing or ambiguous age or sex information
- Patients with documented evidence of valvular disease
- Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the date of anticoagulant initiation
- Patients with prior use of any oral anticoagulant
Data sourced from ClinicalTrials.gov (NCT01847547). 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. Informational only — not medical advice.