UMIN-CTR Clinical Trial

Public title

Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI

Acronym

Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI

Scientific Title

Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI

Scientific Title:Acronym

Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI

Region

Japan

Condition

effort angina pectoris or asymptomatic myocardial ischemia

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate whether values of coagulometer are clinically useful for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI, by analyzing the changed volume in PRU and coagulometer values and their correlation before and after administration of two antiplatelet medicines including prasugrel

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Correlation between values of PRU and the coagulometer

Key secondary outcomes

1. Amount changed in coagulometer values
2. Subgroup analysis by the changed amount of coagulometer values
3. Correlation between coagulometer values and patients' background data
4. Subgroup analysis by coagulometer values
5. Safety of the study drugs (frequency of adverse events)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria are included in this study.
1. PCI is scheduled due to having effort angina pectoris or asymptomatic myocardial ischemia
2. Currently not on any antiplatelet medicines (excepting aspirin)
3. Patients who are at age of 20 or older when providing their written consent (both male and female)
4. Patients can give their consent in a written form

Key exclusion criteria

Patients who fall into any of the following criteria are excluded from participating in the study.
1. At high risks of bleeding
2. Have an experience of hypersensitivity to aspirin or prasugrel in the past
3. Currently pregnant, or possibly pregnant, or planning to be pregnant during the study
4. Had used P2Y12 inhibitor within two weeks before providing written consent
5. Have been prescribed with antiplatelets such as clopidogrel, cilostazol, sarpogrelate hydrochloride, etc. excluding aspirin
6. Currently on any anticoagulant, or planning to use an anticoagulant
7. Had joined other clinical study within the last month or currently being part of a clinical study, or planning to join other study while participating in this study
8. Other condition that the researcher thinks the participant is inappropriate to participate

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Prof. Mitsuaki Isobe

Organization

Tokyo Medical and Dental University

Division name

Cardiovascular Medicine, Medical Hospital

Zip code

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-3813-6111

Email

isobemi.cvm@tmd.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroki Takayama

Organization

Soiken Inc.

Division name

Clinical Study Support Division

Zip code

Address

NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo 101-0052

TEL

03-3295-1350

Homepage URL

Email

takayama@soiken.com

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

DAIICHI SANKYO COMPANY, LIMITED

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

05

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

05

Month

11

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2018

Year

09

Month

30

Day

Other related information

This is a pilot study which attempts to evaluate the clinical usefulness of dielectric coagulometer to monitor the efficacy of using antiplatelet medicine in patients undergone elective PCI by analyzing the correlation between values of PRU and coagulometer. The study drugs are prasugrel and aspirin, and the target number of our subjects is 50 patients who are scheduled to have PCI.

* Study design
This is a prospective, observational study carried out at one research institute. We only have one study group with two observation points (baseline and 4th week); no comparison groups are included in this study. The study period ends on July 31, 2017.

* Subjects recruitment
Patients visit the hospital and meet the inclusion criteria are qualified to be the participants of this study. Of those who are able to give their consent in a written form are enrolled. The enrollment period is until May 30, 2017.

* Evaluation items
1. Background information of the subjects
Age, sex, height, body weight, BMI, blood pressure, abdominal circumference, history of smoking, medication intake, anamnesis, and comorbidity

2. General medical checkup
Vital sign, blood test

3. Information on Medication
Regarding information of medicines taken during the study period

4. Platelet aggregation activity:
Values of PRU and coagulometer are assessed by VerifyNow(R) and dielectric coagulometer(R), respectively.

Registered date

2016

Year

05

Month

31

Day

Last modified on

2019

Year

02

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025989