Condition category
Haematological Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof F.R. Rosendaal

ORCID ID

Contact details

Leiden University Medical Centre (LUMC)
Department of Clinical Epidemiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5264037
f.r.rosendaal@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P99-134; NTR319

Study information

Scientific title

Acronym

Study hypothesis

Long acting coumarin derivatives can reach a more stable anticoagulant effect. Short acting coumarins are more easy to adjust. The half-life of warfarin lies between the half-life of acenocoumarol and phenprocoumon and can thereby possibly have the advantage of long acting coumarins as well as the advantage of short acting coumarins.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Anticoagulant treatment

Intervention

1. Treatment group: oral anticoagulant treatment with warfarin
2. Control group: oral anticoagulant treatment with phenprocoumon

Intervention type

Drug

Phase

Not Specified

Drug names

Phenprocoumon, warfarin

Primary outcome measures

Time spent within therapeutic range, time to the first international normalised ratio (INR) in range, percentage of INRs above range after initiation scheme, reaction of INR to interruption of coumarin or vitamin K administration.

Secondary outcome measures

1. Bleeding complications
2. Thrombotic complications

Overall trial start date

01/03/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. No current use of anticoagulants
2. Aged 18 to 85 years
3. Indication for the use of oral anticoagulants
4. Living in the working area of the Leiden Anticoagulation Clinic
5. Adequate intelligence, informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Pregnancy
2. Chemotherapy
3. Haemo- or peritoneal dialysis
4. Plasmapheresis
5. Contra-indication for the use of oral anticoagulants

Recruitment start date

01/03/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

http://www.lumc.nl/

Funders

Funder type

University/education

Funder name

Leiden University Medical Centre (LUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes