WHITE Study: WHIch Decision After a First Venous ThromboEmbolism?

Sponsor

Arianna Anticoagulazione Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT04646993

Collaborator

(none)

1,200

Enrollment

Location

48.9

Actual Duration (Months)

24.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The WHITE study is a multicenter, multinational, investigators-initiated, observational, prospective study conducted in a consecutive series of ambulatory patients who had completed the recommended or practicable period of anticoagulation after a first-ever episode of venous thromboembolism (VTE)

The general aim of the study is to evaluate the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulant therapy.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism

Detailed Description

The WHITE study is an international, non-profit, multicenter, observational, prospective and no profit study 3,200 subjects having experienced a first-ever episode of DVT of the lower limbs and/or PE, receive anticoagulation therapy for a period as recommended by international and/or local practice guidelines will be enrolled across all the countries participating to the study.

When this recommended period expires, the attending physician has to decide whether to continue with anticoagulation, switch to anti-thrombotic of another class, or stop any prophylactic pharmacological treatment.

The primary objective of the study is the evaluation of the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulation therapy.

The secondary objective is the collection of data during the follow-up: the frequency of thromboembolic complications, of bleeding complications, or death from any cause.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Which Decision After a First Venous Thromboembolism? The WHITE Study

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Feb 28, 2022

Outcome Measures

Primary Outcome Measures

Number of patients who continue or stop the anticoagulant treatment [From the end of the 3rd month to the end of 12th month of anticoagulant treatment]
Registration of number of patients who continue or stop the treatment; registration of type reasons guiding the attending physician's decision on the management of secondary prevention (eg: Bleeding score, laboratory test, presence of residual vein trombosis, risk or recurrence)

Secondary Outcome Measures

Frequence of adverse events during follow-up [Frome the first day of enrollment up to 24 monhts]
the frequency of thromboembolic complications, of bleeding complications, or death from any cause monitored during the follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

subjects who provided a written informed consent and authorization for disclosure of protected health information;
male and female adult or elderly patients of any ethnicity having had a first-ever event of provoked or unprovoked DVT of the lower limbs and/or PE and treated with oral anticoagulant
for whom the center is in possession of all the data relevant to the index event;
having a permanent reference contact.

Exclusion Criteria:

subjects <18 years old;
subjects unable or unwilling to issue the written informed consent;
subjects for whom the information relevant to the index event are incomplete or inaccessible to the Investigator;
subject in whom the index event was a DVT not of the lower limbs;
subjects with life expectancy of less than 2 years;
subjects participating in any other clinical study, regardless of its nature;
subjects considered, by the attending physician, unable to comply with the study procedures.