Evaluating factors affecting anticoagulant use in elderly patients with atrial fibrillation in Italy
A Multicenter Prospective Observational Double Cohort Study to Evaluate the Associations Between Clinical Characteristics and Use of Oral Anticoagulants in Italian Elderly Patients Suffering From NVAF.
This study is trying to see how well elderly people with atrial fibrillation in Italy are using blood thinners and what factors might affect their treatment over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT05232643 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the use of oral anticoagulants among elderly patients diagnosed with non-valvular atrial fibrillation (NVAF) in Italy. It will assess various clinical characteristics and the persistence of anticoagulant therapy over a one-year period. Participants must be naïve to anticoagulant treatments or have not received them in the six months prior to enrollment. The study will include a multidimensional geriatric assessment to ensure comprehensive evaluation of the participants' health status.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals diagnosed with any type of non-valvular atrial fibrillation who have not received anticoagulant therapy in the past six months.
Not a fit: Patients with valvular atrial fibrillation or those requiring anticoagulant therapy for other medical conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of anticoagulant management in elderly patients, potentially leading to improved treatment strategies.
How similar studies have performed: While this study focuses on a specific demographic and condition, similar observational studies have shown success in understanding anticoagulant use in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Diagnosis of any type (e.g. persistent, permanent, paroxysmal) of Non-Valvular Atrial Fibrillation (NVAF) documented in the participant's medical chart based on electrocardiogram (ECG) results, or diagnosed at enrollment * Naïve to anticoagulant treatments, or not having received anticoagulant treatments during the 6 months prior to enrollment * Multidimensional geriatric assessment (MGA) performed at enrollment, or anyway no more than 3 months before in case of stable disease (i.e. no relevant events) in the previous 3 months Exclusion Criteria: * Valvular atrial fibrillation (AF) due to artificial heart valve * Medical conditions (apart from NVAF) requiring anticoagulant therapy (such as deep vein thrombosis or pulmonary embolism) * Use of inappropriate direct-acting oral anticoagulant (DOAC) doses based on the current summary of product characteristics (SmPC) for any drugs
Where this trial is running
Milan, MI
- Local Institution - 0001 — Milan, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
- Email: Clinical.Trials@bms.com
- Phone: please email:
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.