Economic and Medical Evaluation of Self-monitoring of Anticoagulation in a Population of Patients Recently Fitted With a Mechanical Heart Valve Compared to Conventional Anticoagulation Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 919
- Locations
- 2
- Primary Endpoint
- Economic and medical evaluation of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
Study Overview
Brief Summary
To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
Detailed Description
Rationale/context:
Long term management of anticoagulant treatment is not straightforward, especially in patients bearing mechanical heart valves due to the requirement of maintaining a high INR over a narrow range.
Due to the narrow therapeutic window of AVK, undesirable events (hemorrhages, thromboembolic accidents) tend to be both serious and common leading to frequent admissions to hospital The self-monitoring of AVK, in addition to conventional monitoring of INR in the laboratory, is now being introduced in several countries (USA and Europe).
Main objective To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
Secondary objectives
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization
- •oral anticoagulant treatment
- •patients with social security cover
- •written informed consent signed by both patient and investigator
Exclusion Criteria
- •women pregnant or liable to become pregnant during the study
- •nursing women
- •patients unable to master the self-monitoring procedures
- •individuals under judicial control or enquiry
- •patients consuming excessive amounts of alcohol ((>40g/j for men et >30g/j for women femmes ; 1 glass = 10g)
- •patients on dialysis
- •patients with incomplete understanding of instructions
- •blind patients and those unable to read
- •presence of circulating anticoagulant
Arms & Interventions
1
Conventional follow-up of anticoagulation
Intervention: Conventional follow-up of anti-coagulation (Device)
2
Self-monitoring of anticoagulation
Intervention: INRatio / Coaguchek XS (Device)
Outcomes
Primary Outcomes
Economic and medical evaluation of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
Time Frame: 12 months
Secondary Outcomes
- - the impact of complications stemming from oral anticoagulant treatment (bleeding, thromboembolic episodes or death) within a population recently fitted with a mechanical hear valve.(12 months)
- the proportion of monthly measurements of INR within the designated range(12 months)
- the inherent cost of each strategy of anticoagulation monitoring(12 month)