Objective of the study is to measure dabigatran trough levels, percentage of dabigatran glucuronidation, and diluted thrombin time, to test whether these levels are different in elderly patients.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Cardiac arrhythmias
- Gastrointestinal haemorrhages NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameter is the dabigatran trough level, which will be analyzed by
multivariate linear regression, with age and renal function as covariates.
Besides this, also median values per age category (< 75, 75-85 and > 85 years)
will be shown and compared. Because of correction for dose, all concentrations
will be shown als ng/ml/mg.
Secondary outcome
Secondary outcomes are:
1) the percentage of each age group having dabigatran trough levels higher than
150 ng/ ml;
2.) the amount and percentage of glucuronidated dabigatran, and relation to the
age of the patient;
3.) the clotting time as diluted thrombin time and it's relation to dabigatran
level and to the amount of glucuronidated dabigatran.
Background summary
Many elderly patients need to use anticoagulants. The new group of oral
anticoagulant medicins has some important benefits for elderly patients when
compared to the current treatment with acenocoumarol or fenprocoumon. But,
since elderly patients have higher bleeding risk when using anticoagulants,
many physicians hesitate to start the new direct oral anticoagulants in very
old patients. Results of previous studies show that dabigatran trough levels
vary a lot between patients, and on average levels are higher in elderly. It is
also known that the risk of gastrointestinal bleedings is higher in elderly,
and the age-related increase in the number of bleedings is even larger in
elderly using dabigatran than in patients on warfarin. Because of this, extra
precaution is needed in the elderly patients. The best plasma concentration for
having best stroke prevention on the one hand and the lowest bleeding risk on
the other hand, is not clear yet. But there is some evidence that when trough
levels are higher than 150 ng /ml the risk of bleeding is increasing much,
while not much extra reduction of stroke risk is gained.
Study objective
Objective of the study is to measure dabigatran trough levels, percentage of
dabigatran glucuronidation, and diluted thrombin time, to test whether these
levels are different in elderly patients.
Study design
The study has an observational design. One blood sample is taken from every
patient for measuring a dabigatran trough level and the other tests as
mentioned before.
Study burden and risks
Patients visit the hospital once for about one and a half hour. After giving
informed consent, they will answer a few questions about medical history,
medication use and weight, and the blood sample will be taken. The burden and
risks are very small. There is no direct benefit for the patient himself. The
benefit on population level is the increase of knowledge about pharmacokinetics
of this quite new anticoagulant in elderly patients. But, in case the measured
level would be elevated very much, the patient and prescribing doctor will be
informed and the dose can be adjusted.
Michelangelolaan 2 -
Eindhoven 5623 EJ
NL
Michelangelolaan 2 -
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Outpatients from cardiology or geriatric clinic.
Dabigatran use since at least 1 week.
Dabigatran dose 2 times daily, 110 or 150 mg.
Indication for dabigatran: atrial fibrillation.
Exclusion criteria
Use of trombocyte aggregation inhibitors.
Use of PgP inhibitors.
Limitation in renal function, clearance (CKD-epi) < 30 ml/min.
Elevation of liver transaminases above 2 x upper limit of normal.
Malignancy.
Body weight below 50 kilograms or above 110 kilograms.
Incapacitated patients.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59428.100.16 |