N/A
Completed N=221,228
Sequential Expansion of Comparative Effectiveness of Anticoagulants
Source: ClinicalTrials.gov NCT02081807 ↗Enrolled (actual)
221,228
Serious AEs
—
Results posted
Oct 2019
Primary outcomePrimary: Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification) — 0.90; 1.01; 0.64; 0.99 Incidence rate per 100 person-years
Summary
This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and 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 Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification) |
0.90; 1.01; 0.64; 0.99; 0.80; 1.02 | — |
| PRIMARY Major Bleeding |
2.43; 5.23; 4.36; 6.06; 6.2; 6.3 | — |
| SECONDARY Stroke or Systemic Embolism |
0.92; 1.13; 1.00; 1.29; 0.81; 1.36 | — |
| SECONDARY Systemic Embolism |
0.23; 0.14; 0.21; 0.22; 0.05; 0.17 | — |
| SECONDARY Ischemic Stroke |
0.63; 0.80; 0.63; 0.90; 0.61; 1.03 | — |
| SECONDARY Hemorrhagic Stroke |
0.07; 0.19; 0.18; 0.18; 0.15; 0.18 | — |
| SECONDARY Stroke Uncertain Classification |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Major Intracranial Bleeding |
0.21; 0.58; 0.44; 0.66; 0.45; 0.69 | — |
| SECONDARY Major Extra-cranial Bleeding |
3.78; 5.37; 6.31; 6.54; 3.51; 6.92 | — |
| SECONDARY Major Gastrointestinal (GI) Bleeding |
2.39; 2.82; 3.82; 3.43; 1.99; 3.59 | — |
| SECONDARY Major Upper Gastrointestinal Bleeding |
0.51; 0.90; 0.99; 0.88; 0.64; 0.89 | — |
| SECONDARY Major Lower Gastrointestinal Bleeding |
2.18; 2.48; 3.40; 3.09; 1.61; 3.17 | — |
| SECONDARY Major Urogenital Bleeding |
0.01; 0.00; 0.02; 0.00; 0.00; 0.00 | — |
| SECONDARY Other Major Bleeding |
2.32; 3.65; 4.33; 4.59; 2.54; 4.86 | — |
| SECONDARY Transient Ischemic Attack (TIA) |
0.21; 0.43; 0.26; 0.31; 0.22; 0.32 | — |
| SECONDARY Myocardial Infarction (MI) |
0.48; 0.60; 0.53; 0.65; 0.57; 0.74 | — |
| SECONDARY Venous Thromboembolism (VTE) |
0.67; 1.14; 1.20; 1.65; 0.57; 1.21 | — |
| SECONDARY Deep Vein Thrombosis (DVT) |
0.46; 0.78; 0.78; 1.09; 0.41; 0.75 | — |
| SECONDARY Pulmonary Embolism (PE) |
0.29; 0.46; 0.54; 0.81; 0.22; 0.62 | — |
Eligibility Criteria
Inclusion criteria
- A recorded diagnosis of atrial fibrillation.
- Initiation of anticoagulant medication (dabigatran (or other new oral anticoagulants as they become available) or warfarin).
- At least 18 years of age on the date of anticoagulant initiation.
- Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) score at least 1
Exclusion criteria
- Patients with missing or ambiguous age or sex information.
- Patients with evidence of valvular disease.
- Patients with less than 12 months enrolment preceding the date of anticoagulant initiation
- Patients with a dispensing of any oral anticoagulant during the 12 months preceding the date of anticoagulant initiation
- Patients with a nursing home stay during the 12 months preceding the date of anticoagulant initiation
Data sourced from ClinicalTrials.gov (NCT02081807). 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.