UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027082 |
|---|---|
| Receipt number | 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 | 2019/12/10 22:53:40 |
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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 | 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
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
cs.thc@oukai.or.jp
Sponsor or person
Institute
Tokorozawa Heart Center
Clinical trial unit
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031043
