NCT03909386

Non-interventional Study on Patients With Atrial Fibrillation and Cancer

Multicenter, Non-interventional Study on Patients With Atrial Fibrillation (AF) and Cancer (Diagnosed Within the Last 3 Years Prior to Enrolment)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,514 (actual)
• Sponsor: Heart Care Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AF and cancer frequently coexist. Since these patients are usually excluded from randomized trials, information on their management and outcome is scarce. Occurrence of relevant clinical events, such as ischemic and hemorrhagic and all-cause mortality and cardiovascular (CV) mortality occurring in patients treated or not with antithrombotic agents needs to be clarified. A prospective observational registry collecting information, in a real world setting, on the clinical profile of patients with these clinical conditions and on the use of antithrombotic drugs in patients with AF and cancer could improve our knowledge on the management of these high risk patients.

Detailed description

International, multicenter, non-interventional study on patients with atrial fibrillation (AF) and cancer (diagnosed within the last 3 years prior to enrolment). The study will be conducted in about 80 sites in italy and 50 sites distributed in other European countries (Belgium, Germany, Ireland, Portugal, Spain, The Netherlands, Turkey). The study will continue till the consecutive recruitment of 1500 patients. The recruitment period will last approximately 24 months. Number of visits per patient: Baseline and 1 year (Final). Physicians will not be required to perform any additional tests, assessments, etc., not in line with their routine medical practice.

Conditions

• Atrial Fibrillation
• Cancer

Timeline

• Start date: 2019-06-26
• Primary completion: 2021-09-30
• Completion: 2022-09-30
• First posted: 2019-04-10
• Last updated: 2023-01-12

Locations

147 sites across 6 countries: Belgium, Ireland, Italy, Netherlands, Portugal, Spain