UMIN-CTR Clinical Trial

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
Institute	Wakayama Medical University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035999