Unique ID issued by UMIN | UMIN000001029 |
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Receipt number | R000001200 |
Scientific Title | Carotid plaque in Human for ALL Evaluations with Aggressive Rosuvastatin Therapy: Evaluation by Magnetic Resonance Imaging |
Date of disclosure of the study information | 2008/02/15 |
Last modified on | 2008/02/13 16:01:38 |
Carotid plaque in Human for ALL Evaluations with Aggressive Rosuvastatin Therapy: Evaluation by Magnetic Resonance Imaging
CHALLENGER trial
Carotid plaque in Human for ALL Evaluations with Aggressive Rosuvastatin Therapy: Evaluation by Magnetic Resonance Imaging
CHALLENGER trial
Japan |
Hypercholesterolemia with carotid plaque
Cardiology | Endocrinology and Metabolism | Neurology |
Vascular surgery | Radiology | Neurosurgery |
Others
NO
To assess the effects of rosuvastatin on the volume and composition of carotid plaques in patients with hypercholesterolemia using MRI method.
Efficacy
Confirmatory
Pragmatic
Not applicable
The percent change of carotid plaque volume and the changes of carotid plaque composition in week 96.
1) Percent change of carotid plaque volume and qualitative plaque change in week 48.
2) Percent changes of LDL-C and HDL-C, hs-CRP, GFR, LDL-C/HDL-C ratio.
3) Exploration of relation between changes of LDL-C and plaque volume/composition, relation between changes of HDL-C and plaque volume/composition, and relation between changes of hs-CRP and plaque volume/composition.
4) Details and incidence of major adverse cardiac and cerebrovascular events.
5) Relation between hyperinsulinemia and carotid plaque.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Rosuvastatin will be administered for 96 weeks at a dosage of 5 mg/day. If treatment for 4 weeks fails to reduce the LDL-C level below 120 mg/dL, the dosage can be increased up to 20 mg/day.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial.
2) Patients aged 20 years or older at the time of giving consent (no limitations on gender or hospitalization status).
3) Patients with hypercholesterolemia and a max-IMT of more than 1.8 mm as measured by ultrasound.
4) Patients with the LDL-C level of more than 120 mg/dL, or patients who have both carotid stenosis and coronary stenosis with the LDL-C level of more than 100 mg/dL.
1) Patients currently receiving other lipid-lowering drugs apart from the test drug.
2) Patients who have received any HMG-CoA reductase inhibitor (statin) within 3 months before the observation period.
3) Patients with severe carotid stenosis and marked calcification.
4) Patients with the fasting TG level of more than 400 mg/dL.
5) Patients with uncontrolled hypertension (DBP100mmHg or SBP200mmHg throughout the observation period).
6) Patients with familial hypercholesterolemia that cannot be controlled by statin therapy.
7) Patients with secondary hyperlipidemia due to thyroid dysfunction, Cushing's syndrome, nephrotic syndrome, systemic lupus erythematosus, etc.
8) Patients receiving LDL apheresis.
9) Patients on treatment with cyclosporine.
10) Patients with renal dysfunction or on hemodialysis.
11) Patients with a history of severe adverse effects or allergy to statins.
12) Patients with confirmed malignancy, possible malignancy, or a history of malignancy.
13) Patients with active liver disease or hepatic dysfunction (ALT, AST, ALP levels more than 2.5 times the upper limit of normal, or a total bilirubin of more than 3.0 mg/dL).
14) Patients with the serum creatinine of more than 1.5 mg/dL.
15) Patients with the serum creatine kinase (CK) level at least 3 times the upper limit of normal.
16) Patients with contraindications to MRI.
17) Patients cannot be taken their MRI pictures.
18) Patients who are ineligible for any other reason in the opinion of the investigator.
50
1st name | |
Middle name | |
Last name | Hiroyuki Daida |
Juntendo University School of Medicine
Department of Cardiovascular Medicine
3-1-3 Hongo, Bunkyo-ku, Tokyo
03-3813-3111
1st name | |
Middle name | |
Last name | Katsumi Miyauchi |
Juntendo University School of Medicine
Department of Cardiovascular Medicine
Juntendo University School of Medicine
Juntendo University School of Medicine
Self funding
NO
2008 | Year | 02 | Month | 15 | Day |
Unpublished
2007 | Year | 07 | Month | 09 | Day |
2007 | Year | 11 | Month | 01 | Day |
2010 | Year | 06 | Month | 01 | Day |
2008 | Year | 02 | Month | 13 | Day |
2008 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001200
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