Venous ThromboembolismWHITENCT04646993
WHITE Study: WHIch Decision After a First Venous ThromboEmbolism?
An observational study of Venous Thromboembolism, run by Arianna Anticoagulazione Foundation at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 1,200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2018to 28 Feb 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which Decision After a First Venous Thromboembolism? The WHITE Study
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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Keywords
- Deep vein thrombosis Anticoagulant Treatment, Lower limbs, Pulmonary embolism, Oral Anticoagulant Treatment
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From the end of the 3rd month to the end of 12th month of anticoagulant treatment
Secondary outcomes (1)
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.
Measured: Frome the first day of enrollment up to 24 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Feb 2018
- Primary completion30 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Arianna Anticoagulazione Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiří Matuška, Prof, Study director, Clinical Trial Centre, Hodonin, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646993
- Sponsor's protocol ID
- WHITE_Final_20170920
- Acronym
- WHITE
- Status last verified
- Mar 2021
- First submitted
- 18 Nov 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Decision After a First Venous Thromboembolism? The WHITE Study
- ClinicalTrials.gov ID
- NCT04646993
- Acronym / sponsor ID
- WHITE / WHITE_Final_20170920
- Conditions
- Venous Thromboembolism
- Keywords
- Deep vein thrombosis Anticoagulant Treatment, Lower limbs, Pulmonary embolism, Oral Anticoagulant Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Arianna Anticoagulazione FoundationUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who continue or stop the anticoagulant treatment
Time frame: 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)
1 secondary outcome
Frequence of adverse events during follow-up
Time frame: Frome the first day of enrollment up to 24 monhts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingObservational study
Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking
Deep Vein Thrombosis (DVT), Thrombus in the Peripheral Venous Vasculature
Active, not recruitingObservational study
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
Sepsis, Venous Thromboembolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiří Matuška, Prof study director
Clinical Trial Centre, Hodonin, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Arianna Anticoagulazione Foundation at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who continue or stop the anticoagulant treatment (time frame: From the end of the 3rd month to the end of 12th month of anticoagulant treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.