UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012616 |
|---|---|
| Receipt number | R000014686 |
| Scientific Title | Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN Studies In Patients With Stable Angina Managed as Elective Case : MECHANISM-Elective |
| Date of disclosure of the study information | 2013/12/20 |
| Last modified on | 2015/09/15 19:19:41 |
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Basic information
Public title
Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN Studies In Patients With Stable Angina Managed as Elective Case : MECHANISM-Elective
Acronym
MECHANISM-Elective
Scientific Title
Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN Studies In Patients With Stable Angina Managed as Elective Case : MECHANISM-Elective
Scientific Title:Acronym
MECHANISM-Elective
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To treat patients with stable coronary artery disease, elective PCI will be performed with the use of an EES, which is the current standard DES. Vascular responses at the site of stent placement will be evaluated by OCT at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio-cerebrovascular events will also be elucidated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of stent-strut coverage determined by OCT at 3 months after stent placement (To observe temporal course from the early stage, the rate of stent-strut coverage in the 1-month arm will also be evaluated in a complementary manner, separately from the 3-month arm.)
To identify the factors defining the strut coverage at 1-month or 3-months, from
OCT index, blood markers, platelet aggregation test immediately after stenting, the strut coverage of 1 to 3 months
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Everolimus-eluting Cobalt Cromium Stent(CoCr-EES),3 month OCT
Interventions/Control_2
Everolimus-eluting Cobalt Cromium Stent(CoCr-EES),1 month OCT
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated;
2) Patients aged 20 to less than 85 years at the time of informed consent
3) Patients who have provided informed consent written by themselves
4) Patients who are able to undergo OCT examinations of the site of stent placement at 1 or 3 months and at 12 months
Key exclusion criteria
1 If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
2 Patients with acute myocardial infarction (AMI)
3 Patients in a state of shock
4 Patients with cardiac failure
5 Patients having a culprit lesion in the left main coronary artery trunk
6 Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate
7 Patients having an in-stent restenosis lesion as the culprit lesion
8 Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit
9 Patients on hemodialysis
10 Cancer patients with a life expectancy of less than 2 years
11 Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months
12 Pregnant women or women expected to become pregnant
13 Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Devision of Cardiovascular Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-881-1212
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanako Omiya |
Organization
The Academic Research Group for Exploring Undiscovered Mechanisms of Cardiovascular Diseases
Division name
Department of cardiovascular medicine
Zip code
Address
19-1 Uchimaru, Morioka, Iwate
TEL
019-651-5111
Homepage URL
komiya@iwate-med.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Abbott Vascular Japan Co., Ltd.
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | Month | 20 | 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
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 18 | Day |
Last modified on
| 2015 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014686
