---
title: Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
nct_id: NCT02921126
overall_status: COMPLETED
sponsor: Bristol-Myers Squibb
study_type: OBSERVATIONAL
primary_condition: Anticoagulation
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02921126.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02921126"
ct_last_update_post_date: 2018-08-08
last_seen_at: "2026-05-12T07:33:02.913Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy

**NCT ID:** [NCT02921126](https://clinicaltrials.gov/study/NCT02921126)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 9914
- **Lead Sponsor:** Bristol-Myers Squibb
- **Collaborators:** Pfizer
- **Conditions:** Anticoagulation
- **Start Date:** 2017-04-30
- **Completion Date:** 2018-08-02
- **CT.gov Last Update:** 2018-08-08

## Brief Summary

To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* are at least 18 years of age at index date
* Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
* Had at least 1 claim with diagnosis of AF anytime in their records

Exclusion Criteria:

* Have a record that is indicative of Valvular Atrial Fibrillation during this period
* Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)
* Have more than one OAC exposure which starts on the same date
```

## Arms

- **High Dose Group** — Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day
- **Low Dose Group** — Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day
- **Other Dose Group** — Invalid Doses / Off-Label

## Primary Outcomes

- **Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy** _(time frame: Approximately 30 months)_

## Secondary Outcomes

- **Distribution of patient demographics at the time of OAC initiation** _(time frame: at baseline)_
- **Distribution of clinical characteristics at the time of OAC initiation** _(time frame: at baseline)_
- **Composite of number and percentage of patients who are persistent with their newly prescribed OAC** _(time frame: Approximately 30 months)_
- **Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy** _(time frame: Approximately 30 months)_
- **Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC** _(time frame: Approximately 30 months)_

## Locations (1)

- Local Institution, Ravenna, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.local institution|ravenna||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02921126.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02921126*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*