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Biomarker and Imaging Study to assess the ability of high doses rosuvastatin to decrease artherosclerosis in coronary arteries.


- candidate number9370
- NTR NumberNTR2872
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-apr-2011
- Secondary IDs2009-237 MEC Erasmus MC
- Public TitleBiomarker and Imaging Study to assess the ability of high doses rosuvastatin to decrease artherosclerosis in coronary arteries.
- Scientific TitleIntegrated Biomarker and Imaging Study: To Assess the Ability of Rosuvastatin to Decrease Necrotic Core in Coronary Arteries.
- ACRONYMIBIS-3
- hypothesisA high dose of rosuvastatin significantly decreases or halt the progress of the necrotic core volume present in a non-intervened coronary segment as assessed by IVUS-VH.
- Healt Condition(s) or Problem(s) studiedCoronary artery disease
- Inclusion criteria1. More than 18 years old;
2. Written informed consent;
3. Patients with stable angina pectoris or unstable angina pectoris (Braunwald Class I-III, B-C) or patients with documented silent ischemia or patients with an acute myocardial infarction;
4. Patients eligible for coronary revascularisation in the native coronary artery/arteries or candidate for invasive coronary diagnostic procedure;
5. Willing to follow all study procedures including adherence to lipid-lowering diet, study visits and compliance with study treatment regimen.
- Exclusion criteria1. Braunwald class IA, IIA, IIIA (unstable angina caused by non-cardiac illness);
2. Women who are pregnant or women of childbearing potential who do not use adequate contraception;
3. Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), Ticlopdine (Ticlid ®) heparin, stainless steel, copper or a sensitivity to contrast media which cannot be adequately pre-medicated;
4. Previous participation in this study;
5. Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult;
6. Planned coronary bypass surgery;
7. Planned major non-cardiac surgery;
8. The subject has a history of bleeding diathesis or coagulopathy;
9. The subject suffered disabling stroke within the past year;
10. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction which, in the judgment of the Investigator, may affect the patient’s ability to complete the study;
11. History of malignancy, except in patients who have been disease-free >5 years or whose only malignancy has been basal or squamous cell skin carcinoma.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 4-feb-2010
- planned closingdate1-okt-2012
- Target number of participants300
- Interventions1. Off-line IVUS-VH of one ‘study vessel’ at baseline and 52 weeks follow-up;
2. LipiScan examination of the ‘study-vessel’ at baseline and 52 weeks follow-up;
3. Blood samples for lipid profile at baseline and 52 weeks follow-up (hs-CRP, genetic, SNP, RNA, proteomic and lipidomic analysis as well as cellular and functional analysis will be obtained);
4. Rosuvastatin 40 mg (uptitrated within 30 days) for 12 months.
- Primary outcomeThe primary objective of this clinical trial is to determine whether 40 mg rosuvastatin during 12 months decreases necrotic core as assessed by IVUS - VH at 52 weeks.
- Secondary outcomeTo determine whether rosuvastatin reduces lipid core as assessed by LipiScan at 52 weeks.
- TimepointsBaseline procedure, followed by follow-up at 2, 6 and 12 months. Angiographic follow-up, including IVUS-Virtual Histology (VH) and LipiScan assessments at 12 month.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P.W.J.C. Serruys
- CONTACT for SCIENTIFIC QUERIES P.W.J.C. Serruys
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Astra Zeneca
- PublicationsN/A
- Brief summaryMore than half of all acute coronary syndromes (ACS) are caused by a rupture of vulnerable atherosclerotic plaque, which is characterized by the presence of a thin inflamed fibrous cap and a large necrotic core pool. Intravascular ultrasound-virtual histology (IVUS-VH) allows tissue characterization of four different plaque compositions, such as fibrous, fibro-fatty, dense calcified and necrotic core. Although a high dosage statin reduces coronary plaque size and necrotic core in carotid arteries, it remains unknown whether there is a similar effect on the necrotic core present in coronary atherosclerotic plaque. The IBIS-3 study is a single-center, non-randomized study designed to evaluate the ability of a high dose rosuvastatin in reducing the necrotic core of a non-intervened coronary segment assessed in vivo with IVUS-VH within 12-months (primary endpoint).
- Main changes (audit trail)
- RECORD27-apr-2011 - 8-mei-2011


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