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Trial record 92 of 179 for:    ERYTHROMYCIN

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
Sponsor:
Information provided by (Responsible Party):
Boudewijn Klop, Sint Franciscus Gasthuis

Brief 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.


Condition or disease Intervention/treatment Phase
Hyperlipidemia Atherosclerosis Drug: Temporary discontinuation of statin therapy Not Applicable

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Apolipoprotein B bound to erythrocytes [ Time Frame: 6 weeks ]
    Change in apollipoprotein B bound to erythrocytes six weeks after cessation of statin therapy


Secondary Outcome Measures :
  1. Apolipoprotein B bound to leukocytes [ Time Frame: Six weeks ]
    Change in apolipoprotein B bound to leukocytes after cessation of statin therapy

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Netherlands
Sint Franciscus Gasthuis
Rotterdam, Zuid Holland, Netherlands, 3004 BA
Sponsors and Collaborators
Sint Franciscus Gasthuis
Investigators
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Study Director: Manuel Castro Cabezas, MD, PhD Sint Franciscus Gasthuis

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boudewijn Klop, MD, Sint Franciscus Gasthuis
ClinicalTrials.gov Identifier: NCT01634906     History of Changes
Other Study ID Numbers: NL37698.101.11
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013
Keywords provided by Boudewijn Klop, Sint Franciscus Gasthuis:
Apolipoprotein B, erythrocytes, statins
Additional relevant MeSH terms:
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Atherosclerosis
Hyperlipidemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents