No registrations found.
ID
Source
Brief title
Health condition
Coronary artery disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
To determine whether rosuvastatin reduces lipid core as assessed by LipiScan at 52 weeks.
Background summary
More 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).
Study objective
A 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.
Study design
Baseline 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.
Intervention
1. 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.
P.W.J.C. Serruys
Rotterdam
The Netherlands
+31 (0)10 4635260
p.w.j.c.serruys@erasmusmc.nl
P.W.J.C. Serruys
Rotterdam
The Netherlands
+31 (0)10 4635260
p.w.j.c.serruys@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2734 |
| NTR-old | NTR2872 |
| Other | MEC Erasmus MC : 2009-237 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |