---
title: Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;
nct_id: NCT04586972
overall_status: COMPLETED
sponsor: "Gérond'if"
study_type: OBSERVATIONAL
primary_condition: Nonvalvular Atrial Fibrillation
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04586972.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04586972"
ct_last_update_post_date: 2025-09-16
last_seen_at: "2026-05-12T06:26:23.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;

**NCT ID:** [NCT04586972](https://clinicaltrials.gov/study/NCT04586972)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 977
- **Lead Sponsor:** Gérond'if
- **Conditions:** Nonvalvular Atrial Fibrillation
- **Start Date:** 2020-09-23
- **Completion Date:** 2024-04-29
- **CT.gov Last Update:** 2025-09-16

## Brief Summary

The main objective of this study is to realize an observational "real life" study conducted in French geriatric settings, to assess safety and efficacy in ≥ 80 year-old patients with nonvalvular Atrial fibrillation (AF) newly treated with Apixaban.

Moreover, in this geriatric population the adequacy of Apixaban dosage and events (bleeding and stroke) will be assessed.

## Detailed Description

It is a muliticentric, observational, prospective study.

This study will be conducted in about 40 geriatric settings in France.

The planned duration of the inclusion period is 27 months in each center.

The follow-up period starts from inclusion up to one year after inclusion with phone contact or unscheduled visit at 3, 6, 9 and 12 months.

During this follow-up, participants physicians will record patients' data during visit directly from the patients or their physicians or their families and by phone.

The following data will be colllected:

* At M0 : Socio-demographics, clinical and biological data; embolic risk and emorrhagic risk scores,cognitive function, number of falls, blood pressure, nutritional assessment, athonomy, comorbidities, data on anticoagulant therapy, treatment discontinuation and clinical evaluation.
* At M3, M6, M9 and M12: • Number of falls, all treatment schedule, record of major bleeding events, record of any other bleeding events, record of other serious events, record of other non-major events, treatment discontinuation, and social and medical environment.
* Only M6 and M12: Renal function (both Cockcroft-Gault, chronic Kidney Disease, epidemiology Collaboration "CKD EPI" and the four variable modification of Diet in renal Disease equation "MDRD")

## Eligibility

- **Minimum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Male or female patients aged 80 years and older.
* Patients with non-valvular atrial fibrillation (documented on electrocardiography or other medical evidence like medical chart, hospital discharge note, physician's letter within 3 years before enrollment).
* Followed in geriatric settings (office consultation, acute care, rehabilitation settings and nursing homes).
* Newly treated (less than 6 months) with Apixaban (5mg twice daily (or 2.5 mg twice daily for patients with 2 of the following criteria : age \> 80 years, creatinine \> 133 μmol/l, weight \< 60 kg)

Exclusion Criteria:

* Patient refusing to participate.
* Participation to a clinical trial.
* Contraindication to use of Apixaban as described in the Summary of Product Characteristics .
```

## Primary Outcomes

- **Assessment of the incidence of bleeding events** _(time frame: 12 months)_

## Secondary Outcomes

- **To determine bleeding risk according (ATRIA bleeding) score** _(time frame: 12 months)_
- **Assessment of compliance with treatment by (Apixaban) according (Morisky) Score** _(time frame: 12 months)_
- **To quantifie risk of hemorrhage according (HEMORR₂HAGES) Score** _(time frame: 12 months)_
- **Assessment of the risk of bleeding according the (HAS-BLED) Score** _(time frame: 12 months)_

## Locations (1)

- Geriatric Department, Broca Hospital, Paris, IIe-de-France, France

## 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)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.geriatric department, broca hospital|paris|iie-de-france|france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04586972.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04586972*  
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