Carotid plaque in Human for ALL Evaluations with Aggressive Rosuvastatin Therapy: Evaluation by Magnetic Resonance Imaging

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000001029
• Date of registration: 15/02/2008
• Prospective Registration: No
• Primary sponsor: Juntendo University School of Medicine
• Public title: Carotid plaque in Human for ALL Evaluations with Aggressive Rosuvastatin Therapy: Evaluation by Magnetic Resonance Imaging
• Scientific title: Carotid plaque in Human for ALL Evaluations with Aggressive Rosuvastatin Therapy: Evaluation by Magnetic Resonance Imaging - CHALLENGER trial
• Date of first enrolment: 2007/11/01
• Target sample size: 50
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001200
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Hiroyuki Daida
• Affiliation: Juntendo University School of Medicine Department of Cardiovascular Medicine

• Name: Katsumi Miyauchi
• Affiliation: Juntendo University School of Medicine Department of Cardiovascular Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 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.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Hypercholesterolemia with carotid plaque

Intervention(s)

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.

Primary Outcome(s)

The percent change of carotid plaque volume and the changes of carotid plaque composition in week 96.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Juntendo University School of Medicine

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 01/06/2010