Very Low Dose Oral Anticoagulation and Thromboembolic and Bleeding Complications

Phase 4

Terminated

• Conditions: Mechanical Heart Valve Recipients
• Interventions: Drug: phenprocoumon

• Registration Number: NCT00528671
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Brief Summary

We aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement.

Detailed Description

In mechanical heart valve recipients, self-management of oral anticoagulation can reduce the risk of developing thromboembolic events and improves long-term survival compared with international normalized ratio (INR) control by a general practitioner. Low-dose INR self-management (INR values of 1.8.-2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients) does not increase the risk of thromboembolic events compared to conventional dose INR self-management. Even in patients with a low INR target range, however, the risk of bleeding events is still higher than the risk of thromboembolism. We therefore perform a prospective, randomized trial in 1,800 patients with mechanical heart valve replacement. During the first six postoperative months, low dose INR self-management will be performed by all patients (INR measurement once a week). Thereafter, 600 patients will continue with this treatment regimen, whereas the other 1,200 patients with perform very low dose oral anticoagulation. Out of these 1,200 patients, 600 will perform INR measurement once a week and 600 patients will perform INR measurement twice a week. Patients are followed up for 24 months.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-11
• Study First Posted: 2007-09-12
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1571

Inclusion Criteria

• Mechanical heart valve recipients

Exclusion Criteria

• Contra-indication to phenprocoumon
• Ulcerous disease with bleeding tendency,
• Hypo- or hypercoagulability
• Dementia
• Missing informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	phenprocoumon	Low dose oral anticoagulation, INR self-management once a week
B	phenprocoumon	very low dose oral anticoagulation, INR self-management once a week
C	phenprocoumon	very low dose oral anticoagulation, INR self-management twice a week

Primary Outcome Measures

Name	Time	Method
Thromboembolic events, Bleeding events, Survival rates	2 years

Secondary Outcome Measures

Name	Time	Method
INR values, Percent of INR values in the target range	2 years

Trial Locations

Locations (1)

Heart and Diabetes Center NRW; 🇩🇪 Bad Oeynhausen, Germany