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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027082
Receipt No. R000031043
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
Date of disclosure of the study information 2017/05/20
Last modified on 2018/10/23

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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
Middle name
Last name Masanori Taniwaki
Organization Tokorozawa Heart Center
Division name Cardiology Department
Zip code
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
Middle name
Last name Hiroyuki Negishi
Organization Tokorozawa Heart Center
Division name General Affairs Division
Zip code
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
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
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
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
2023 Year 06 Month 30 Day
Date trial data considered complete
2023 Year 06 Month 30 Day
Date analysis concluded
2024 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 21 Day
Last modified on
2018 Year 10 Month 23 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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