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Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy

NCT01634906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2013-03-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Temporary discontinuation of statin therapy

All statins, e.g. atorvastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin

Sponsors & Collaborators

  • Sint Franciscus Gasthuis

    lead OTHER

Principal Investigators

  • Manuel Castro Cabezas, MD, PhD · Sint Franciscus Gasthuis

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01634906 on ClinicalTrials.gov