Comparative study of the stability of oral anticoagulant therapy using phenprocoumon or warfarin.
| ISRCTN | ISRCTN60446748 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60446748 |
| Protocol serial number | P99-134; NTR319 |
| Sponsor | Leiden University Medical Centre (LUMC) (Netherlands) |
| Funder | Leiden University Medical Centre (LUMC) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 02/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof F.R. Rosendaal
Scientific
Scientific
Leiden University Medical Centre (LUMC)
Department of Clinical Epidemiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5264037 |
|---|---|
| f.r.rosendaal@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Phenprocoumon, warfarin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Bleeding complications |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Key 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 |
| Key exclusion criteria | 1. Pregnancy 2. Chemotherapy 3. Haemo- or peritoneal dialysis 4. Plasmapheresis 5. Contra-indication for the use of oral anticoagulants |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
