Clinical trial NCT04646993: WHITE Study: WHIch Decision After a First Venous ThromboEmbolism?
Official title: Which Decision After a First Venous Thromboembolism? The WHITE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Deep vein thrombosis Anticoagulant Treatment
Lower limbs
Pulmonary embolism
Oral Anticoagulant Treatment
Lead sponsor: Arianna Anticoagulazione Foundation
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients of any ethnicity having had a first-ever event of provoked or unprovoked DVT of the lower limbs and/or PE given maintenance anticoagulants (NOACs, VKAs, or LMWHs) according to the local procedures (usually for 3 to 12 months) and to be re-evaluated to decide the treatment to be prescribed after such period by the attending physicians

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients who continue or stop the anticoagulant treatment
timeFrame: From the end of the 3rd month to the end of 12th month of anticoagulant treatment
Secondary outcomes:
measure: Frequence of adverse events during follow-up
timeFrame: Frome the first day of enrollment up to 24 monhts
Other outcomes:
Locations:
city: Hodonín
country: Czechia
facility: Clinical Trial Centre, MATMED
Study officials:
affiliation: Clinical Trial Centre, Hodonin, Czech Republic
name: Jiří Matuška, Prof
role: STUDY_DIRECTOR
References: