The aim of the study is to investigate the effect of statins on ery-apoB levels.
ID
Source
Brief title
Condition
- Other condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
hypercholesterolemie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Erythrocyte-bound apolipoprotein B before and after discontinuation of statin
therapy.
Secondary outcome
none
Background summary
Preliminary data has shown that erythrocyte-bound apolipoprotein B (ery-apoB)
has a protective effect on atherosclerosis. Moreover, a modest but significant
negative correlation existed between ery-apoB and plasma apoB and LDL-C in
subjects without statins but not in subjects with statins. The direct effects
of statins on ery-apoB are unknown.
Study objective
The aim of the study is to investigate the effect of statins on ery-apoB
levels.
Study design
A non-randomized intervention study. Ery-apoB will be measured twice in
volunteers who are on statin therapy for medical reasons. After a baseline
measurement of ery-apoB volunteers will discontinue their statin use for a
period of six weeks followed by a second measurement of ery-apoB. Consecutively
subjects will start with their original statin therapy again.
Intervention
Temporary discontinuation of statin therapy for a period of six weeks.
Study burden and risks
Volunteers will visit the outpatient clinic twice, the second visit will be
exactly six weeks after the first visit. The volunteers* general practitioner
and medical specialist (internist or cardiologist) will be informed about their
participation. Subjects have to fast for 10 hours before every visit and venous
blood samples will be drawn on both visits (a total of 36ml of blood). Subjects
will discontinue their usual statin therapy for a period of three weeks. No
major risks are involved with temporary discontinuation of statin therapy in
stable chronic cardiovascular disease. Volunteers will receive 25 euros for
participation. Subjects can be informed concerning their lipid profile and
efficacy of their current statin use. Participation serves to further
investigate the relation of statins and potentially beneficial binding of apoB
on erythrocytes.
Postbus 10900
3004 BA, Rotterdam
NL
Postbus 10900
3004 BA, Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Aged 18 years or older
Use of statin therapy
Exclusion criteria
A cardiovascular event (myocardial infarction, percutaneous coronary intervention or stroke) in the past 6 months.
The use of any other lipid lowering drugs besides a statin, for example ezetimibe or a fibrate in the past 6 months.
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 | NL37698.101.11 |