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Very Low Dose Oral Anticoagulation and Thromboembolic and Bleeding Complications

NCT00528671 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1571

Last updated 2013-12-11

No results posted yet for this study

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.

Conditions

  • Mechanical Heart Valve Recipients

Interventions

DRUG

phenprocoumon

The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.8 - 2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients, INR-self management once a week

DRUG

phenprocoumon

The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management once a week

DRUG

phenprocoumon

The daily phenprocoumon dose administered should achieve an international normalized ratio (INR) of 1.6-2.1 for aortic valve recipients and 2.0 - 2.5 for mitral or double valve recipients, INR self management twice a week

Sponsors & Collaborators

  • Klinikum Ludwigshafen

    collaborator OTHER

  • University of Kiel

    collaborator OTHER

  • Heart and Diabetes Center North-Rhine Westfalia

    lead OTHER

Principal Investigators

  • Heinrich Koertke, MD · Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00528671 on ClinicalTrials.gov