START-Register: Survey on Anticoagulated Patients Register

Sponsor
GUALTIERO PALARETI
Study ID
NCT02219984
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anticoagulants — DRUG

Study Details

This is a phase 4 cohort prospective, open, national, multicentre study that collects data on history of patients treated chronically with anticoagulant drugs, including the novel direct oral anticoagulants (DOACs). The Registry is designed solely for observational purposes and is not intended to have any influence on the treatment of the single patients included. Patients are included when they start the anticoagulant treatment, whatever the drug used, or when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral anticoagulants, provided that the therapy is expected to last at least 3 months. The general aims of the study are to provide a better evaluation of efficacy and safety of different treatment options, and to improve our understanding of the risks/benefits of the various anticoagulant drugs and the different therapy options. The Registry is open to the participation of clinical centres or individual professionals (now called Participants) that are involved with management of anticoagulated patients.

Key Dates

First listed
Aug 19, 2014
Start date
Oct 31, 2011
Status verified
Feb 2023
Primary completion
Jul 31, 2025
Completion
Nov 30, 2027

Study Design

Enrollment
15,410 participants (estimated)

Arms

  • Arm: patients anticoagulated

Primary Outcome Measure

incidence of complications (number per cent patient-years of treatment) [ Time Frame: at 1 year of follow-up ]

Central Contacts

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