START-Register: Survey on Anticoagulated Patients Register

ConditionsAtrial Fibrillation Venous Thromboembolism Heart Valve Diseases or Prosthesis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorGUALTIERO PALARETI

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age >= 18 years

Disqualifiers

< 18 years

not willing to sign informed consent

Trial population

Are included in the Registry patients who need chronic anticoagulation for atrial fibrillation, or venous thromboembolism, or heart valve diseases or prosthesis, or other clinical conditions requiring anticoagulation. For the sampling method, participants are instructed to choose and declare one modality of inclusion for VKA treated patients: one week per month, or one day per week (always the same), etc. For patients treated with DOACs (low number in our country) it is recommended to include all patients progressively

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Anticoagulants
Drug

Treatment groups

15,410 Participants

are divided into 1 treatment group

Group A: patients anticoagulated1 intervention

Trial outcomes

Primary outcomes

incidence of complications (number per cent patient-years of treatment)

from date of inclusion in the registry until the date of first documented major complication or date of death from any cause, whichever came first, assessed up to 5 years.

Time frame

at 1 year of follow-up

Secondary outcomes

Percentage of Time in the therapeutic range (TTR)

This only applies to patients who receive VKAs for treatment; from date of inclusion in the registry until the date of VKA treatment was stopped, or date of death from any cause, whichever came first, assessed up to 5 years

Time frame

at 1 year

Other outcomes

percentage of patients who stop anticoagulant treatment

This applies only to patients anticoagulated for atrial fibrillation; from date of inclusion in the registry until the date anticoagulant treatment was discontinued, or date of death from any cause, whichever came first, assessed up to 5 years

Time frame

at 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GUALTIERO PALARETI

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor institution

Arianna Anticoagulazione Foundation

Collaborator

Source ClinicalTrials.gov

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