UMIN-CTR Clinical Trial

Basic information
Public title	A randomized comparison of acute thrombogenecity and long-term vascular healing between biodegradable-polymer (BP) versus durable polymer (DP) everolimus-eluting stents in acute ST-elevation myocardial infarction
Acronym	CONNECT Study
Scientific Title	A randomized comparison of acute thrombogenecity and long-term vascular healing between biodegradable-polymer (BP) versus durable polymer (DP) everolimus-eluting stents in acute ST-elevation myocardial infarction
Scientific Title:Acronym	CONNECT Study
Region	Japan Europe

Condition
Condition	Acute myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the biodegradable polymer everolimus-eluting stent (Synergy) compared with the durable polymer everolimus-eluting stent (Xience Alpine) in acute ST-segment elevation myocardial infarction (STEMI) in terms of acute thrombogenecity immediately after stent implantation and formation of neoatherosclerosis at 3 years
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of neoatherosclerosis lesion which is defined as the presence of a fibroatheroma or fibrocalcific plaques or macrophages within the neointima of a stented segment with a longitudinal extension of >= 1 mm at 3 years
Key secondary outcomes	The athero-thrombotic material area (tissue protorusion + isolated intraluminal detect) within the stent strut after primary PCI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are 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	Synergy (Everolimus-eluting stent with biodegradable polymer)
Interventions/Control_2	Xience Alpine (Everolimus-eluting stent with durable polymer)
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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1.Age =>18 years 2.Primary PCI within 24 hours of symptom onset 3.ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguuoius anterior leads 4.Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents
Key exclusion criteria	1.Female ofchildbearing potential (age < 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. 2.Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, cobalt chromium, platinum chromium, everolimus or contrast material 3.Inability to understand and provide informed consent 4.Currently participating in another trial before reaching first endpoint 5.Mechanical complications of acute myocardial infarction 6.Acute myocardial infarction secondary to stent thrombosis or restenosis 7.Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period 8.Noncardiac comorbid conditions are present with life expectancy <3years or that may result in protocol noncompliance 9.History of bleeding diathesis or known coagulopathy 10.Use of oral anticoagulation 11.Age >=90 years 12.LV-function at index procedure <=20% 13.Cancer under active treatment (chemotherapy) 14.Hemodynamic instability following primary PCI 15.Chronic kidey disease (Creatinine - Clearance < 30ml/min) 16.OCT technically not feasible (severe calcification, tortuosity)
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Taniwaki
Organization	Tokorozawa Heart Center
Division name	Cardiology Department
Zip code	359-1142
Address	2-6-11 Kamiarai, Tokorozawa, Saitama, Japan
TEL	04-2940-8611
Email	taniwaki.thc@oukai.or.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Negishi
Organization	Tokorozawa Heart Center
Division name	General Affairs Division
Zip code	359-1142
Address	2-6-11 Kamiarai, Tokorozawa, Saitama, Japan
TEL	04-2940-8611
Homepage URL
Email	cs.thc@oukai.or.jp

Sponsor
Institute	Tokorozawa Heart Center Clinical trial unit
Institute
Department

Funding Source
Organization	Boston Scientific
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	Saitama Medical University, Ethical Committee
Address	38 Hongo, Moroyama, Iruma, Saitama
Tel	049-276-1662
Email	tokutei@saitama-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	2017 Year 05 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	Open public recruiting
Date of protocol fixation	2017 Year 05 Month 10 Day
Date of IRB	2017 Year 06 Month 26 Day
Anticipated trial start date	2017 Year 06 Month 28 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2023 Year 12 Month 31 Day
Date trial data considered complete	2024 Year 12 Month 31 Day
Date analysis concluded	2024 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 21 Day
Last modified on	2019 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031043