WHITE Study: WHIch Decision After a First Venous ThromboEmbolism?

Venous Thromboembolism Clinical Trial

— WHITE  

Official title:

Which Decision After a First Venous Thromboembolism? The WHITE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646993
• Other study ID #: WHITE_Final_20170920
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2021
• Source: Arianna Anticoagulazione Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: February 28, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. subjects who provided a written informed consent and authorization for disclosure of protected health information;

2. 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

3. for whom the center is in possession of all the data relevant to the index event;

4. having a permanent reference contact.

Exclusion Criteria:

1. subjects <18 years old;

2. subjects unable or unwilling to issue the written informed consent;

3. subjects for whom the information relevant to the index event are incomplete or inaccessible to the Investigator;

4. subject in whom the index event was a DVT not of the lower limbs;

5. subjects with life expectancy of less than 2 years;

6. subjects participating in any other clinical study, regardless of its nature;

7. subjects considered, by the attending physician, unable to comply with the study procedures.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Czechia	Clinical Trial Centre, MATMED	Hodonín

Sponsors (1)

Lead Sponsor	Collaborator
Arianna Anticoagulazione Foundation

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who continue or stop the 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)	From the end of the 3rd month to the end of 12th month of anticoagulant treatment
Secondary	Frequence of adverse events during follow-up	the frequency of thromboembolic complications, of bleeding complications, or death from any cause monitored during the follow-up.	Frome the first day of enrollment up to 24 monhts