Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy (EBABAST)
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|ClinicalTrials.gov Identifier: NCT01634906|
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : March 22, 2013
Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB) may be protective against atherosclerosis. However, statins may have an effect on ery-apoB.
Objective: 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.
Study population: patients on statin therapy aged 18 years or older.
Intervention: temporary discontinuation of statin therapy for a period of six weeks.
Main study endpoints: changes in ery-apoB levels.
Risks, burden and benefits on participation: 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 six weeks. No major risks are involved with temporary discontinuation of statin therapy in stable chronic cardiovascular disease. Volunteers will receive 25 euro's in total for participation. Participation serves to further investigate the relation of statins and potentially beneficial binding of apoB on erythrocytes.
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemia Atherosclerosis||Drug: Temporary discontinuation of statin therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|Experimental: Discontinuation of statin therapy||
Drug: Temporary discontinuation of statin therapy
All statins, e.g. atorvastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin
Other Name: e.g. Crestor, Lipitor
- Apolipoprotein B bound to erythrocytes [ Time Frame: 6 weeks ]Change in apollipoprotein B bound to erythrocytes six weeks after cessation of statin therapy
- Apolipoprotein B bound to leukocytes [ Time Frame: Six weeks ]Change in apolipoprotein B bound to leukocytes after cessation of statin therapy
- Leukocyte activation [ Time Frame: six weeks ]
Change in leukocyte activation markers after cessation of statin therapy:
- cytoplasmatic MPO in neutrophils
- CD11b expression on monocytes and neutrophils
- CD66b expression on neutrophils
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634906
|Sint Franciscus Gasthuis|
|Rotterdam, Zuid Holland, Netherlands, 3004 BA|
|Study Director:||Manuel Castro Cabezas, MD, PhD||Sint Franciscus Gasthuis|