UnknownPhase 3

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

France150 participantsStarted 2019-12-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Exclusion Criteria: * 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 signif…

What they're measuring

Treatment adherence mesured by Medication Event Monitoring System Cap

Timeframe: at 6 months

Trial details

NCT IDNCT04141254

SponsorUniversity Hospital, Brest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

Contact for this trial

Francis COUTURAUD, PhD

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