Venous Thrombosis or Pulmonary EmbolismAntiCoagChoiceNCT03889457
What Treatment for Patients With Phlebitis or Pulmonary Embolism ?
An observational study of Venous Thrombosis or Pulmonary Embolism, run by Rennes University Hospital at 1 site in France.
Trial summary
The objective of the "anticoagchoice" study is to analyze the preferences of people suffering from phlebitis, in terms of anticoagulant, to improve adherence to these treatments, to adapt the medical prescriptions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis or Pulmonary Embolism
- What is being tested?
- anticoagulation choice
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2019to 12 Feb 2021
- 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: Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age in France (via the vascular doctors of the French Society of Vascular Médicine).
Who may be able to join
- Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age.
- No Exclusion Criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rennes University Hospital
Rennes, 35000
Guillaume Mahe, guillaume.mahe@chu-rennes.fr
About this study
Official title: Patients' Choice in Terms of Anticoagulant Therapy in Venous Thrombo- Embolism Disease. AntiCoagChoice Study
The objective of the "anticoagchoice" study is to analyze the preferences of people suffering from phlebitis, in terms of anticoagulant, to improve adherence to these treatments, to adapt the medical prescriptions.
Read the detailed description
Venous thromboembolism (VTE) is the third leading cause of cardiovascular death, with an increase in annual incidence with age. With the advent of direct oral anticoagulants, the management of deep vein thrombosis and pulmonary embolism has evolved in recent years and these treatments are widely prescribed. There are studies comparing the different anticoagulant treatments used in venous thrombosis, which show no inferiority of treatment (injectable or oral) compared to others. Drug delivery modalities have been shown to affect adherence, and thus treatment efficacy. It seems fundamental to focus on patients' drug preferences in VTE to ensure the best possible compliance. These preferences seem to depend on the personal history of each patient. In addition, no studies have been conducted on patient preferences for anticoagulant therapy for VTE: this is the goal of the "anticoagchoice" study.
- Conditions
- Venous Thrombosis or Pulmonary Embolism
- Being tested
- anticoagulation choice
- Keywords
- Deep Vein Thrombosis, Superficial Vein Thrombosis, Anticoagulant, Patient Compliance, Preference, Venous Thrombosis, pulmonary embolism
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticoagulation choiceOther
Type of anticoagulant chosen by the patient (oral or injectable).
| Study group | Role | What they receive |
|---|---|---|
| Patients with venous thromboembolic disease | Patients with deep vein thrombosis, superficial or muscular vein thrombosis, pulmonary embolism, over 18 years of age. Receives: Other: anticoagulation choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to analyze patient treatment preferences in venous thromboembolic disease.
The primary outcome: To compare the proportion of patients choosing oral anticoagulation vs patients choosing injectable route.
Measured: the time required for a consultation: 30 minutes
Secondary outcomes (2)
compare patients choosing oral anticoagulation vs patients choosing an injectable route
proportions of patients choosing an oral anticoagulation vs. patients choosing an injectable pathway depending on the duration of treatment (3 months, 6 months or more),
Measured: the time required for a consultation: 30 minutes
compare patients choosing oral anticoagulation vs patients choosing an injectable route
Identify factors influencing these choices, depending on the characteristics of the patient (history, age, gender, social environment, personal experience).
Measured: the time required for a consultation: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start12 Feb 2019
- Primary completion12 Feb 2021 (estimated)
- Study completion12 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Thrombosis or Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SFMV (French Society of Vascular Medicine)
- Responsible party
- Sponsor
- Investigators
- Guillaume Mahe, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889457
- Sponsor's protocol ID
- 35RC18_3002_AntiCoagChoice
- Acronym
- AntiCoagChoice
- Status last verified
- Feb 2019
- First submitted
- 15 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laneelle D, Le Brun C, Mauger C, Guillaumat J, Le Pabic E, Omarjee L, Mahe G; SFMV VTE Study Group. Patient Characteristics and Preferences Regarding Anticoagulant Treatment in Venous Thromboembolic Disease. Front Cardiovasc Med. 2021 Jun 21;8:675969. doi: 10.3389/fcvm.2021.675969. eCollection 2021.
PubMed 34235186
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Choice in Terms of Anticoagulant Therapy in Venous Thrombo- Embolism Disease. AntiCoagChoice Study
- ClinicalTrials.gov ID
- NCT03889457
- Acronym / sponsor ID
- AntiCoagChoice / 35RC18_3002_AntiCoagChoice
- Conditions
- Venous Thrombosis or Pulmonary Embolism
- Keywords
- Deep Vein Thrombosis, Superficial Vein Thrombosis, Anticoagulant, Patient Compliance, Preference, Venous Thrombosis, pulmonary embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- SFMV (French Society of Vascular Medicine)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 12 Feb 2021 (estimated)
- Study completion
- 12 Feb 2021 (estimated)
- First posted
- 26 Mar 2019 (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 objective of the "anticoagchoice" study is to analyze the preferences of people suffering from phlebitis, in terms of anticoagulant, to improve adherence to these treatments, to adapt the medical prescriptions.
Detailed description
Venous thromboembolism (VTE) is the third leading cause of cardiovascular death, with an increase in annual incidence with age. With the advent of direct oral anticoagulants, the management of deep vein thrombosis and pulmonary embolism has evolved in recent years and these treatments are widely prescribed. There are studies comparing the different anticoagulant treatments used in venous thrombosis, which show no inferiority of treatment (injectable or oral) compared to others. Drug delivery modalities have been shown to affect adherence, and thus treatment efficacy. It seems fundamental to focus on patients' drug preferences in VTE to ensure the best possible compliance. These preferences seem to depend on the personal history of each patient. In addition, no studies have been conducted on patient preferences for anticoagulant therapy for VTE: this is the goal of the "anticoagchoice" study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with venous thromboembolic disease | – | Other: anticoagulation choicePatients with deep vein thrombosis, superficial or muscular vein thrombosis, pulmonary embolism, over 18 years of age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age in France (via the vascular doctors of the French Society of Vascular Médicine).
Key inclusion criteria (2 listed)
- Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age.
- No Exclusion Criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anticoagulation choiceType of anticoagulant chosen by the patient (oral or injectable). | Other | Patients with venous thromboembolic disease |
Primary outcome
The primary objective of this study is to analyze patient treatment preferences in venous thromboembolic disease.
Time frame: the time required for a consultation: 30 minutes
The primary outcome: To compare the proportion of patients choosing oral anticoagulation vs patients choosing injectable route.
2 secondary outcomes
compare patients choosing oral anticoagulation vs patients choosing an injectable route
Time frame: the time required for a consultation: 30 minutes
compare patients choosing oral anticoagulation vs patients choosing an injectable route
Time frame: the time required for a consultation: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 34235186Laneelle D, Le Brun C, Mauger C, Guillaumat J, Le Pabic E, Omarjee L, Mahe G; SFMV VTE Study Group. Patient Characteristics and Preferences Regarding Anticoagulant Treatment in Venous Thromboembolic Disease. Front Cardiovasc Med. 2021 Jun 21;8:675969. doi: 10.3389/fcvm.2021.675969. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Guillaume Mahe principal investigator
Rennes University Hospital
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 Thrombosis or Pulmonary Embolism, run by Rennes University Hospital at 1 site in France.
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 26 Mar 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecile Ferragu (02 99 28 25 55, cecile.ferragu@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to analyze patient treatment preferences in venous thromboembolic disease. (time frame: the time required for a consultation: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889457, which also lists 1 linked publication.
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 26 Mar 2019.