UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001223 |
|---|---|
| Receipt number | 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 | 2023/11/13 10:37:12 |
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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 | Hiroyoshi |
| Middle name | |
| Last name | Yokoi |
Organization
Kokura Memorial Hospital
Division name
Department of cardiology
Zip code
802-8555
Address
1-1 Kifune-machi, Kokura-kita-ku, Kitakyushu-shi, Fukuoka 802-8555
TEL
093-921-2231
info-ld@csp.or.jp
Public contact
Name of contact person
| 1st name | Study support centre |
| Middle name | |
| Last name | Study support centre |
Organization
Public Health Research Foundation
Division name
Lifestyle-related disease clinical study support office
Zip code
169-0051
Address
1-1-7 Nishi-Waseda, Shinjuku-ku 169-0051
TEL
03-5287-2633
Homepage URL
info-ld@csp.or.jp
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
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
Public Health Research Foundation
Address
1-1-7 Nishi-waseda Shinjyuku Tokyo
Tel
03-5287-2633
info-ld@csp.or.jp
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
社会保険小倉記念病院
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
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2008 | Year | 06 | Month | 02 | Day |
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
| 2011 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001445
