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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name