Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sint Franciscus Gasthuis
• Treatments: Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 18 years or older

• use of a statin

Exclusion Criteria:

• use of other lipid lowering drugs, other than statins

• a cardiovascular event in the past 6 months