UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001029
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

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Basic information

Public title

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

Acronym

CHALLENGER trial

Scientific Title

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

Scientific Title:Acronym

CHALLENGER trial

Region

Japan


Condition

Condition

Hypercholesterolemia with carotid plaque

Classification by specialty

Cardiology Endocrinology and Metabolism Neurology
Vascular surgery Radiology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effects of rosuvastatin on the volume and composition of carotid plaques in patients with hypercholesterolemia using MRI method.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

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

Key secondary outcomes

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.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

Key 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&#61619;100mmHg or SBP&#61619;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.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Daida

Organization

Juntendo University School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Katsumi Miyauchi

Organization

Juntendo University School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Juntendo University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 02 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Date of protocol fixation

2007 Year 07 Month 09 Day

Date of IRB


Anticipated trial start date

2007 Year 11 Month 01 Day

Last follow-up date

2010 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 02 Month 13 Day

Last modified on

2008 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001200


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name