Very Low Dose Oral Anticoagulation and Thromboembolic and Bleeding Complications (ESCAT III)

Heart and Diabetes Center North-Rhine Westfalia

Status and phase: Terminated; Phase 4

Conditions: Mechanical Heart Valve Recipients

Treatments: Drug: phenprocoumon

Study type: Interventional

Funder types: Other

Identifiers

NCT00528671

002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,571 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mechanical heart valve recipients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,571 participants in 3 patient groups

A

Active Comparator group

Description:

Low dose oral anticoagulation, INR self-management once a week

Treatment:

Drug: phenprocoumon

Drug: phenprocoumon

Drug: phenprocoumon

B

Active Comparator group

Description:

very low dose oral anticoagulation, INR self-management once a week

Treatment:

Drug: phenprocoumon

Drug: phenprocoumon

Drug: phenprocoumon

C

Experimental group

Description:

very low dose oral anticoagulation, INR self-management twice a week

Treatment:

Drug: phenprocoumon

Drug: phenprocoumon

Drug: phenprocoumon