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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR319 |
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Date of registration:
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09/09/2005 |
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Primary sponsor: |
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Public title:
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Comparitive study of the stability of oral anticoagulant therapy using phenprocoumon or warfarin.
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Scientific title:
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Comparitive study of the stability of oral anticoagulant therapy using phenprocoumon or warfarin. - N/A |
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Date of first enrolment:
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1/3/2004 |
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Target sample size:
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500 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=319 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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F.R.
Rosendaal |
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Address:
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Leiden University Medical Center (LUMC),
Department of Clinical Epidemiology,
P.O. Box 9600, Albinusdreef 2
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5264037 |
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Email:
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f.r.rosendaal@lumc.nl |
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Affiliation:
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Name:
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Y.
Leeuwen, van |
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Address:
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Leiden University Medical Center (LUMC),
Department of Clinical Epidemiology,
P.O. Box 9600, Albinusdreef 2
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5261384 |
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Email:
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y.van_leeuwen@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. No current use of anticoagulants;
2. Aged 18?85;
3. Indication for the use of oral anticoagulants;
4. Living in the workingarea of the Leiden Anticoagulation Clinic;
5. Adequate intelligence, informed consent.
Exclusion criteria: 1. Pregnancy;
2. Chemotherapy;
3. Hemo- of peritoneal dialysis;
4. Plasmafereses;
5. Contra-indication for the use of oral anticoagulants.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Anticoagulants
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Intervention(s)
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Treatment group: oral anticoagulant treatment with warfarin.
Control group: oral anticoagulant treatment with phenprocoumon.
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Primary Outcome(s)
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Time spent within therapeutic range, time to the first INR in range, percentage of INRs above range after initiation scheme, reaction of INR to interruption of coumarin or vitamin K administration.
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Secondary Outcome(s)
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1. Bleeding complications;
2. Thrombotic complications.
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Secondary ID(s)
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ISRCTN60446748
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P99-134
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Source(s) of Monetary Support
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[default]
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