Condition category
Haematological Disorders
Date applied
26/09/2006
Date assigned
26/09/2006
Last edited
08/09/2008
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 Center (LUMC)
Department of Clinical Epidemiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 4037
f.r.rosendaal@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P02-089; NTR724

Study information

Scientific title

Acronym

ICAD

Study hypothesis

The equations used by most current algorithms are usually based on a simple pharmacodynamic model, which implies a linear function between the international normalised ratio (INR) and the dosage. Our new algorithm consists of two sub-models in which the first sub-model describes the collective influence of all processes on the effect of the vitamin K antagonist and the second sub-model describes the relationship between the dosage and the corresponding INR. The second sub-model includes a variable parameter to reflect the sensitivity of the patient that may change over time. Because of the inclusion of a parameter that reflects the sensitivity of the patient we think it is better capable of proposing a dosage that leads to an INR within the therapeutic range.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

Anticoagulant treatment

Intervention

Oral anticoagulant dosage supported by the new algorithm (ICAD) and oral anticoagulant dosage supported by the standard algorithm (TRODIS).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Percentage of time therapeutic range
2. Proportion of visits in which the algorithm gave a proposal
3. Proportion that was accepted by the physician

Secondary outcome measures

1. Mean time between visits
2. Bleeding events
3. Thrombotic events

Overall trial start date

14/08/2003

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Indication for long term anticoagulant therapy
2. Aged between 18 and 80

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

712

Participant exclusion criteria

1. Participation in the patient self-management program
2. Staying long periods abroad
3. Terminal stage of disease

Recruitment start date

14/08/2003

Recruitment end date

01/09/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Foundation Bazis (now known as iSOFT) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Thrombosis Foundation (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

Results in http://www.ncbi.nlm.nih.gov/pubmed/15869584

Publication citations

  1. Results

    Pasterkamp E, Kruithof CJ, Van der Meer FJ, Rosendaal FR, Vanderschoot JP, A model-based algorithm for the monitoring of long-term anticoagulation therapy., J. Thromb. Haemost., 2005, 3, 5, 915-921, doi: 10.1111/j.1538-7836.2005.01266.x.

Additional files

Editorial Notes