UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Kengo Tsukahara
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
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	Kengo Tsukahara
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/30599063
Results
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/icdr_e/ctr_view.cgi?recptno=R000003562