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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Venous Thromboembolism trials