UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011232
Receipt number R000012827
Scientific Title Platelet function assay and the discontinuance time of aspirin and clopidogrel before surgery
Date of disclosure of the study information 2013/07/31
Last modified on 2014/04/28 10:12:20

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Basic information

Public title

Platelet function assay and the discontinuance time of aspirin and clopidogrel before surgery

Acronym

preoperative platelet function assay with aspirin and clopidogrel

Scientific Title

Platelet function assay and the discontinuance time of aspirin and clopidogrel before surgery

Scientific Title:Acronym

preoperative platelet function assay with aspirin and clopidogrel

Region

Asia(except Japan)


Condition

Condition

before undergoing elective surgery under general anesthesia

Classification by specialty

Hematology and clinical oncology Anesthesiology Laboratory medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

compare platelet function test using PFA-100 with col/EPI cartiridge by their own antiplatelet therapy(only aspirin vs aspirin plus clopidogrel) and the periods of antiplatelet discontinuation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

There was a significant decrease in PFA value when the periods of antiplatelet discontinuation exceed seven days, not five days

Key secondary outcomes



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

35 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with an ASA physical status I-II who were gone off within 30 days or maintained their own antiplatelet therapy (only aspirin 100mg per day or aspirin 100mg per day plus clopidogrel 75mg per day) before undergoing elective surgery under general anesthesia

Key exclusion criteria

patients with severe systemic disease, a hypovolemic state, congenital platelet disorder, known history of aspirin resistance, or who were being treated with other anticoagulants or herbal medications

Target sample size

188


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Il-Ok Lee

Organization

Korea University

Division name

Anesthesiology and Pain Medicine

Zip code


Address

Gurodong-ro 148, Guro-gu, Seoul, Republic of Korea

TEL

82-2-2626-1437

Email

iloklee@korea.ac.kr


Public contact

Name of contact person

1st name
Middle name
Last name Il-Ok Lee

Organization

Korea University

Division name

Anesthesiology and Pain Medicine

Zip code


Address

Gurodong-ro 148, Guro-gu, Seoul, Republic of Korea

TEL

82-2-2626-1437

Homepage URL


Email

iloklee@korea.ac.kr


Sponsor or person

Institute

Korea University

Institute

Department

Personal name



Funding Source

Organization

Korea University

Organization

Division

Category of Funding Organization

Outside Japan

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

2013 Year 07 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 06 Month 14 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 30 Day

Last follow-up date

2014 Year 01 Month 03 Day

Date of closure to data entry

2014 Year 01 Month 06 Day

Date trial data considered complete

2014 Year 01 Month 06 Day

Date analysis concluded

2014 Year 01 Month 06 Day


Other

Other related information

PFAs are determined on the morning of the day of surgery. we assess the difference of the groups classified by their own antiplatelet therapy (aspirin only or aspirin+clopidogrel) and the periods of antiplatelet discontinuation.
A receiver operating characteristic (ROC) analysis and the area under the curve (AUC) was achieved by logistic regression to evaluate the logistic predicted probability and the performance of classification by the periods of antiplatelet discontinuation.


Management information

Registered date

2013 Year 07 Month 19 Day

Last modified on

2014 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012827


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name