Impact of Early Debriefing and Enhanced Educative Components on Direct Oral Anticoagulant Adherence After Venous Thromboembolism.

NCT04141254 | Unknown Phase 3

• 1 other identifier: 29BRC18.0198
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 10

Brief Summary

Venous thromboembolism (VTE) is a frequent multifactorial and potential life-threatening disease. Once VTE has been diagnosed, anticoagulation should be started and prolonged for at least three to six months in order to reduce the risk of fatal and non-fatal recurrences and long-term sequelae. The development of direct oral anticoagulants (DOACs) has represented a major advance in patients' care as there is evidence that DOACs are associated with a decreased risk of bleeding without loss in efficacy and as it simplifies treatment modalities for the patients and the physician. However, as DOACs do not require laboratory monitoring, adherence of anticoagulation is difficult to evaluate and traditional programs built on patients receiving VKA may no longer be applicable to patients on DOAC. In order to increase treatment adherence in patients on DOAC for an acute VTE and to improve the quality of life, the impact of specific educational programs on DOACs, taking in account both therapeutic (DOAC) and medical illness (VTE) dimensions needs to be investigated. In patients with an acute episode of VTE treated for at least 6 months, the main hypothesis is that early debriefing and educative components added to a standardized visit one month after an acute VTE has the potential to improve patient's adherence to APIXABAN therapy at 6 months of follow-up.

Conditions

Venous Thromboembolism

Keywords

Anticoagulant; Direct oral anticoagulant; Debriefing; Recurrent venous thromboembolism; anticoagulant-related bleeding

Outcome Measures

Primary Outcomes (1)

• Treatment adherence mesured by Medication Event Monitoring System Cap

  Adherence to apixaban therapy at 6 months after an acute episode of VTE measured by the MEMSCap™ will be evaluated. The main criteria for adherence measurement will be the number of days where patients took adequately apixaban divided by the number of expected days of prescription. An additional evaluation will be the number of taken pills divided by the expected taken pills.

  at 6 months

Secondary Outcomes (7)

• Treatment adherence mesured by Medication Event Monitoring System Cap

  at 1 month and 3 months

• Quality of life after an acute VTE

  At 6 months

• Quality of life after an acute VTE

  At 6 months

• Recurrent VTE (Symptomatic recurrent pulmonary embolism and Symptomatic recurrent deep-vein thrombosis) diagnosed on the basis of a clinical suspicion

  during a study treatment period of 6 months

• Major and clinically relevant non major bleeding

  during a study treatment period of 6 months

Study Arms (2)

Debriefing

EXPERIMENTAL

a standardized follow-up visit at one month associated with "debriefing and enhanced educative component"

Other: Debriefing and educative components

Without debriefing

OTHER

a standardized follow-up visit at one month alone (i.e.; without "debriefing and educative component")

Other: Without debriefing and educative components

Interventions

Debriefing and educative components OTHER

The patient will receive early debriefing and enhanced educative components added to a standardized visit at one month

Debriefing

Without debriefing and educative components OTHER

Patient will receive a standardized visit alone (without debriefing and enhanced educative components ) at one month

Without debriefing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years old, the upper limit of which will be left to the discretion of the investigator according to the risk benefit balance
• Patients with indications for a minimum of 6 months of anticoagulation after an acute documented VTE that was diagnosed 7 days ago or less (i.e.; symptomatic PE or proximal or distal DVT)
• Social security affiliation.
• Patient who signed inform consent form

You may not qualify if:

• Known allergy to apixaban, allergy to any of the excipients
• Unable or refusal to give informed consent
• Indication for anticoagulation other than DVT or PE (e.g.; atrial fibrillation, mechanic valves…)
• Treatment with investigational drug in the past 1 month
• Chronic liver disease or chronic hepatitis
• Renal insufficiency with creatinine \<30 ml / min on Cockcroft and Gault formula
• Known antiphospholipid syndrome
• Dual anti-platelet therapy or aspirin at dosage \>100 mg per day
• Concomitant use of a strong inhibitor of cytochrome P450 3A4 (CYP3A4) (e.g., a protease inhibitor for human immunodeficiency virus infection or azole-antimycotics agents ketoconazole, itraconazole, voriconazole, posaconazole) or a CYP3A4 inducer (e.g., rifampin, carbamazepine, or phenytoin),
• Active cancer of less than 6 months
• Active pregnancy or expected pregnancy in the next 6 months
• Planned surgery in the next 6 months
• No effective contraception in women of childbearing age
• Life expectancy \<6 months
• Patient with active clinically significant bleeding

Sponsors & Collaborators

• University Hospital, Brest: lead
• Bristol-Myers Squibb: collaborator

Study Sites (10)

CHU Angers

Angers, 49933, France

NOT YET RECRUITING

HIA Brest

Brest, 29240, France

RECRUITING

CHRU de Brest

Brest, 29609, France

RECRUITING

CHU de Clermont Ferrand - Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

RECRUITING

APHP Hôpital Louis Mourier

Colombes, 92700, France

RECRUITING

CHU de Grenoble - Hôpital Nord Michallon

Grenoble, 38700, France

RECRUITING

HEGP

Paris, 75015, France

RECRUITING

CHU de Rennes - Hôpital Sud

Rennes, 35203, France

NOT YET RECRUITING

CHU de Saint Etienne - Hôpital Nord

Saint-Etienne, 42055, France

RECRUITING

CHU de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Francis COUTURAUD, PhD

CONTACT

2 98 34 73 48; francis.couturaud@chu-brest.fr

Anne-Sophie VEILLON

CONTACT

anne-sophie.morvan@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a multicenter, randomized trial with blind evaluation, parrallel arm, and using a Zelen randomization process

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 28, 2019
• Study Start: December 27, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)