UMIN-CTR Clinical Trial

Public title

Safety and eficity of 2.5mg prasugrel therapy in the eldely or low body weight Japanese patients undergoing percutaneous coronary intervention

Acronym

2.5mg Prasugrel therapy in the eldely or low body weight Japanese patients

Scientific Title

Safety and eficity of 2.5mg prasugrel therapy in the eldely or low body weight Japanese patients undergoing percutaneous coronary intervention

Scientific Title:Acronym

2.5mg Prasugrel therapy in the eldely or low body weight Japanese patients

Region

Japan

Condition

Ischemic Heart Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The aim of this study is to evaluate safety and efficacy 2.5mg dose of prasugrel.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

The primary efficacy endpoint is the variation in the rate of low on-treatment platelet reactivity (LPR) among Prasugrel 3.75 mg and prasugrel 2.5 mg maintenance dose.
We measure the platelet inhibition as the PRU from the VerifyNow P2Y12 platform assay with the predefined thresholds of PRU < 95 for LPR

Key secondary outcomes

The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) and optimal on treatment platlet reactivity (OPR) amomg clopidogrel 75 mg maintenance dose , prasugrel 3.75 mg maintenance dose and prasugrel 2.5mg maintenance dose, the difference of the mean PRU and mean inhibition rate, the average value of the change of PRU, the relation between coronary stent and platlet inhibition, the relation between date from InBody S20 and platelet inhibition and the relation between CYP2C19 polymorphism and platelet inhibition.
The safety endpoints are the rate of bleeding events according to BARC criteria, ischemic events, stent thrombosis, myocardial infarction during this study.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Change from 3.75mg to 2.5mg Prasugrel

Interventions/Control_2

Change from 2.5mg to 3.75mg Prasugrel

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with ischemic heart disease who will undergo or have undergone percutaneous coronary intervention
2. Patients who are taking both aspirin and clopidogrel
3. Patients who are provided of the written agreement
4. Over 75 years old and/or less than 50kg
5. At least four weeks after an ACS event
6. Four weeks or more after PCI or coronary artery bypass graft

Key exclusion criteria

1. Patients with contraindications to prasugrel
2. Patients who have severe liver problem
3. Patients who have severe kidney problem
4. History of stroke or transient ischemic attack
5. low platelet counts (less than 10*10^4)
6. Patients who are taking anticoagulants
7. Patients who are planned to administer thrombolytic agents
8. Patients scheduled for PCI or CABG during this study
9. Patients who are taking ticlopidine or cilostazol or prasugrel.
10. Patients judged as inappropriate for trial entry

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Yoshio Kobayashi

Organization

Chiba University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan

TEL

043-226-2340

Email

aapa6508@chiba-u.jp

Name of contact person

1st name
Middle name
Last name	Shinichi Wakabayashi

Organization

Chiba University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan

TEL

043-226-2340

Homepage URL

Email

worldpeacewaka@yahoo.co.jp

Institute

Chiba University Hospital

Institute

Department

Personal name

Organization

Chiba Univerity, Department of Cardiovascular Medicine

Organization

Division

Category of Funding Organization

Self funding

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

千葉大学医学部付属病院(千葉県)

Date of disclosure of the study information

2015

Year

10

Month

21

Day

URL releasing protocol

Publication of results

Published

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

Main results already published

Date of protocol fixation

2015

Year

09

Month

28

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

20

Day

Last modified on

2018

Year

05

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022460