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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001223
Receipt No. R000001445
Scientific Title A study to evaluate the efficacy of Rosuvastatin for patients with coronary plaque utilizing aggressive lipid lowering treatment
Date of disclosure of the study information 2008/07/01
Last modified on 2010/12/20

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Basic information
Public title A study to evaluate the efficacy of Rosuvastatin for patients with coronary plaque utilizing aggressive lipid lowering treatment
Acronym APOLLO
Scientific Title A study to evaluate the efficacy of Rosuvastatin for patients with coronary plaque utilizing aggressive lipid lowering treatment
Scientific Title:Acronym APOLLO
Region
Japan

Condition
Condition Hypercholesterolemia
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether aggressive lipid lowering treatment with Rosuvastatin decreases coronary plaque in hyperlipidemic patients, who are diagnosed to be necessary to undergo elective percutaneous coronary intervention (PCI), by randomized parallel controlled study. The target is a group with no administration of statin and primary endpoints of the efficacy are changes of minimal lumen diameter (MLD) and average lumen diameter (ALD), which measured by quantitative coronary angiography (QCA).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes from baseline in MLD and ALD at month 24
Key secondary outcomes Virtual histology intravascular ultrasound (VH-IVUS) and 64-row multi-detector-row computed tomography (64-row MDCT) will be conducted in patients who meet enablement requirement, and the relationship between changes in quantity of coronary plaque and quality of plaque will be evaluatedexploratory .
Changes of intima media thickness (IMT) in carotid artery will be exploratory evaluated in patients who meet enablement requirement.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rosuvastatin 5 mg (1 tablet of rosuvastatin 5 mg tablet or 2 tablets of rosuvastatin 2.5 mg tablet) will be orally administered once daily for 24 months after PCI.
Interventions/Control_2 No serum lipid lowering agents including statin will be administered and a wait-and-see approach will be taken until 24 months after PCI.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with fasting LDL-C >= 100 mg/dL and < 140 mg/dL.
2) Patients with fasting triglyceride < 400 mg/dL
3) Patients who are able to submit written consent agreement by themselves
Key exclusion criteria (1) Patients with familial hypercholesterolemia
(2) Patients who took lipid lowering agent within 1 month before the study .
(3) Patients who have undergone PCI/CABG in separate sites of coronary arteries.
(4) Patients with history of unstable angina or ischemic syndrome.
(5) Patients with concomitant cardiac failure and patients who have lowered cardiac functions.
(6) Patients receiving insulin treatment
(7) Patients receiving cyclosporine
(8) Patients with hepatic function disorder (AST/ALT>=100 IU/L)
(9) Patients with renal function disorder (serum creatinine >= 1.5 mg/dL)
(10) Patients with serum CK >= 500 IU/L
(11) Pregnant women and women suspected of being pregnant
(12) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder
(13) Patients with drug abuse or alcoholism
(14) Patients with serious complication
(15) Patients who are ineligible at physicians' discretion
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yokoi Hiroyoshi
Organization Kokura Memorial Hospital
Division name Department of cardiology
Zip code
Address 1-1 Kifune-machi, Kokura-kita-ku, Kitakyushu-shi, Fukuoka 802-8555
TEL 093-921-2231
Email

Public contact
Name of contact person
1st name
Middle name
Last name Study support centre
Organization Public Health Research Foundation
Division name Lifestyle-related disease clinical study support office
Zip code
Address 1-1-7 Nishi-Waseda, Shinjuku-ku 169-0051
TEL 03-5287-2633
Homepage URL
Email

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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 07 Month 01 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 No longer recruiting
Date of protocol fixation
2008 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2009 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 06 Month 30 Day
Last modified on
2010 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001445

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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