NCT00528671

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,571

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

7.8 years

First QC Date

September 11, 2007

Last Update Submit

December 10, 2013

Conditions

Mechanical Heart Valve Recipients

Keywords

phenprocoumonINR self-managementmechanical heart valve replacementbleedingthromboembolism

Outcome Measures

Primary Outcomes (1)

  • Thromboembolic events, Bleeding events, Survival rates

    2 years

Secondary Outcomes (1)

  • INR values, Percent of INR values in the target range

    2 years

Study Arms (3)

A

ACTIVE COMPARATOR

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

Drug: phenprocoumon

B

ACTIVE COMPARATOR

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

Drug: phenprocoumon

C

EXPERIMENTAL

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

Drug: phenprocoumon

Interventions

phenprocoumonDRUG

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

A

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanical heart valve recipients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Diabetes Center NRW

Bad Oeynhausen, 32545, Germany

Location

Related Publications (4)

  • Koertke H, Minami K, Boethig D, Breymann T, Seifert D, Wagner O, Atmacha N, Krian A, Ennker J, Taborski U, Klovekorn WP, Moosdorf R, Saggau W, Koerfer R. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation. 2003 Sep 9;108 Suppl 1:II75-8. doi: 10.1161/01.cir.0000089185.80318.3f.

    PMID: 12970212BACKGROUND

  • Koertke H, Zittermann A, Wagner O, Koerfer R. Self-management of oral anticoagulation therapy improves long-term survival in patients with mechanical heart valve replacement. Ann Thorac Surg. 2007 Jan;83(1):24-9. doi: 10.1016/j.athoracsur.2006.08.036.

    PMID: 17184625BACKGROUND

  • Koertke H, Zittermann A, Mommertz S, El-Arousy M, Litmathe J, Koerfer R. The Bad Oeynhausen concept of INR self-management. J Thromb Thrombolysis. 2005 Feb;19(1):25-31. doi: 10.1007/s11239-005-0937-1.

    PMID: 15976964BACKGROUND

  • Koertke H, Zittermann A, Minami K, Tenderich G, Wagner O, El-Arousy M, Krian A, Ennker J, Taborski U, Klovekorn WP, Moosdorf R, Saggau W, Morshuis M, Koerfer J, Seifert D, Koerfer R. Low-dose international normalized ratio self-management: a promising tool to achieve low complication rates after mechanical heart valve replacement. Ann Thorac Surg. 2005 Jun;79(6):1909-14; discussion 1914. doi: 10.1016/j.athoracsur.2004.09.012.

    PMID: 15919283BACKGROUND

MeSH Terms

Conditions

HemorrhageThromboembolism

Interventions

Phenprocoumon

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Heinrich Koertke, MD

    Institute of Applied Telemedicine, Heart and Diabetes Center North-Rhine Westfalia, 32545 Bad Oeynhausen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

January 1, 2006

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

DE(1)