UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002940 |
|---|---|
| Receipt number | 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 11:14:10 |
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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
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
k-tsuka@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Division of Cardiology, Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003562
