UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031526
Receipt number R000035999
Scientific Title COMparison of clinical outcomes Following percutaneous coronary intervention versus Optimal medical therapy based on gray zone fractional flow Reserve in sTABLE angina patients with intermediate coronary artery stenosis
Date of disclosure of the study information 2018/03/01
Last modified on 2020/05/26 14:53:58

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Basic information

Public title

COMparison of clinical outcomes Following percutaneous coronary intervention versus Optimal medical therapy based on gray zone fractional flow Reserve in sTABLE angina patients with intermediate coronary artery stenosis

Acronym

COMFORTABLE prospective

Scientific Title

COMparison of clinical outcomes Following percutaneous coronary intervention versus Optimal medical therapy based on gray zone fractional flow Reserve in sTABLE angina patients with intermediate coronary artery stenosis

Scientific Title:Acronym

COMFORTABLE prospective

Region

Japan


Condition

Condition

coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine whether percutaneous coronary intervention (PCI) plus medical therapy is superior to medical therapy alone in reducing major cardiovascular events in patients presenting coronary stenosis with grey-zone fractional flow reserve (FFR).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Major adverse cardiac events defined as a composite of death, non-fatal myocardial infarction, and unplanned target vessel revascularisation

Key secondary outcomes

- MACE at 2 and 5 years
- death from any cause at 1, 2, and 5 years
- cardiovascular death at 1, 2, and 5 years
- target vessel myocardial infarction at 1, 2, and 5 years
- non-target vessel myocardial infarction at 1, 2, and 5 years
- all myocardial infarction at 1, 2, and 5 years
- target vessel revascularisation at 1, 2, and 5 years
- non-target vessel revascularisation at 1, 2, and 5 years
- all revascularisation at 1, 2, and 5 years
- stent thrombosis at 1, 2, and 5 years
- angina symptom assessed by Canadian Cardiovascular Society (CCS) functional classification at 1, 2, and 5 years


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

percutaneous coronary intervention (PCI) + medical therapy

Interventions/Control_2

medical therapy alone

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 with an intermediate coronary lesion presenting with FFR between 0.75 and 0.80
2. Patients must be more than 20 years old.
3. Provision of informed consent prior to any study specific procedures

Key exclusion criteria

1. culprit vessel in acute coronary syndrome
2. patients with untreated significant lesions (%DS>70 and/or FFR <0.75) in coronary arteries other than the target vessel.
3. unstable hemodynamics
4. hemodyalysis
5. previous bypass graft surgery
6. allergy to antiplatelet therapy, anticoagulants, and contrast medium
7. intracranial and/or gastrointestinal bleeding
8. planned surgical procedure within 12 months
9. Known terminal disease with a life expectancy of less than 12 months
10. pregnant women
11. significant valvular disease
12.
13.1. left main disease (%DS > 50%) or planned PCI to left main disease
13.2 chronic total occlusion
13.3 Heavily calcified or tortuous vessels where inability to cross the lesion with a pressure wire is expected.
13.4 diffuse diseases, heavily calcified lesions, small vessels, and/or aneurysmal lesions where PCI is thought to be unsuitable by operators.

Target sample size

410


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Akasaka

Organization

Wakayama Medical University

Division name

Cardiovascular Medicine

Zip code

641-8510

Address

811-1 Kimiidera Wakayama Japan

TEL

073-441-0621

Email

akasat@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Yasutsugu
Middle name
Last name Shiono

Organization

Wakayama Medical University

Division name

Cardiovascular Medicine

Zip code

641-8510

Address

811-1 Kimiidera Wakayama Japan

TEL

073-441-0621

Homepage URL


Email

doors@herb.ocn.ne.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Seijin kekkanbyou kenkyu shinkou zaidan

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

Wakayama Medical University

Address

811-1 Kimiidera Wakayama

Tel

073-447-2300

Email

wa-rinri@wakayama-med.ac.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



Other administrative information

Date of disclosure of the study information

2018 Year 03 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

Open public recruiting

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB

2018 Year 04 Month 09 Day

Anticipated trial start date

2020 Year 05 Month 26 Day

Last follow-up date

2026 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 01 Day

Last modified on

2020 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035999


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name