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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002940
Receipt No. R000003562
Scientific Title An association between post-treatment platelet reactivity and ischemic and bleeding events after stent implantation in patients with acute coronary syndromes: A multicenter, prospective, cohort study.
Date of disclosure of the study information 2010/01/04
Last modified on 2019/01/10

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Basic information
Public title An association between post-treatment platelet reactivity and ischemic and bleeding events after stent implantation in patients with acute coronary syndromes: A multicenter, prospective, cohort study.
Acronym Platelet function monitoring in patients with acute coronary syndromes
Scientific Title An association between post-treatment platelet reactivity and ischemic and bleeding events after stent implantation in patients with acute coronary syndromes: A multicenter, prospective, cohort study.
Scientific Title:Acronym Platelet function monitoring in patients with acute coronary syndromes
Region
Japan

Condition
Condition Acute Coronary Syndromes
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the association between post-treatment platelet reactivity and ischemic and bleeding events after stent implantation in patients with acute coronary syndromes
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Frequency of 1-year composite endpoints (including cardiovascular death, myocardial infarction, stent thrombosis, target vessel revascularization, non-target vessel revascularization, and ischemic stroke and major bleeding) in the first quartile group, the fourth, and the other 2 quartiles according to post-treatment platelet reactivity assessed by VerifyNow P2Y12 assay before PCI.
Myocardial infarction is defined as universal definition in 2007, stent thrombosis is defined as ARC definition(definite, probable, possible), and major bleeding is defined as REPLACE-2 criteria.
Key secondary outcomes 1) Frequency of 1-year adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, stent thrombosis, target vessel revascularization, non-target vessel revascularization, and ischemic stroke) and major bleeding in patients with high post-treatment platelet reactivity before PCI.
High post-treatment platelet reactivity is defined as P2Y12 reaction unit (PRU) >= 235 assessed by VerifyNow P2Y12 assay before PCI.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Patients with acute coronary syndromes who are scheduled to undergo coronary stent implantation treated with aspirin and clopidogrel are enrolled.
Key exclusion criteria 1) use of warfarin, ticlopidine, cilostazole, glycoprotein IIb/IIIa inhibitor, or fibrinolytics within 7 days before enrollment or duing study period.
2) serum hemoglobin level <10 g/dl or >18 g/dl
3) platelet count <100,000 /mm3 or >500,000 /mm3
4) hematologic or malignant disordor
5) major bleeding events within 7 days before enrollment
6) severe chronic renal failure (serum creatinine > 2mg/dl)
7) severe liver dysfunction (hepatic cirrhosis or portal hypertension)
8) acute coronary syndromes caused by stent thrombosis or in-stent restenosis
9) drug allergy of aspirin or clopidogrel
10) participating in the other trial (phase 1-3)
11) women of pregnant, childbearing potential or lactation
12) patients who are not allowed to participate in the trial by judgement of the treating physician
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Tsukahara
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email k-tsuka@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Tsukahara
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email k-tsuka@urahp.yokohama-cu.ac.jp

Sponsor
Institute Division of Cardiology, Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Daiichi Sankyo Co.,LTD.
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 横浜市立大学附属市民総合医療センター(神奈川県)
神奈川県立循環器呼吸器病センター(神奈川県)
済生会横浜市南部病院(神奈川県)
藤沢市民病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30599063
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 Completed
Date of protocol fixation
2009 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 07 Month 31 Day
Date trial data considered complete
2015 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information Prospective cohort study

Management information
Registered date
2009 Year 12 Month 25 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003562

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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