UMIN-CTR Clinical Trial

Public title

Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Patients with Coronary Artery Disease

Acronym

Switching from Clopidogrel to Prasugrel

Scientific Title

Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Patients with Coronary Artery Disease

Scientific Title:Acronym

Switching from Clopidogrel to Prasugrel

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 the platelet inhibition after switching from maintenance clopidogrel to prasgurel.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary efficacy endpoint is the variation in the rate of high on-treatment platelet reactivity (HPR) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose.
We measure the platelet inhibition as the PRU from the VerifyNow P2Y12 platform assay with the predefined thresholds of PRU > 208 for HPR and PRU < 95 for LPR, respectively.

Key secondary outcomes

The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose and 2 weeks after switching again from prasugrel 3.75 mg to clopidogrel 75 mg, the difference of the mean PRU and mean inhibition rate between clopidogrel 75 mg and prasugrel 3.75 mg, the average value of the change of PRU, and the relation between CYP2C19 polymorphism and platelet inhibition.
The safety endpoints are the rate of bleeding events according to TIMI bleeding criteria, ischemic events, stent thrombosis, myocardial infarction during this study.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Switching from Maintenance Clopidogrel to Prasgurel

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

80

years-old

>=

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 for more than 14 days
3. Patients who are provided of the written agreement
4. Twenty to 80 years old
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. Weigh 50 kg or less
5. low platelet counts (less than 10*10^4)
6. Pregnant
7. Patients who are taking anticoagulants
8. Patients who are planned to administer thrombolytic agents
9. Patients scheduled for PCI or coronary artery bypass graft during this study
10. Patients who are taking ticlopidine or cilostazol
11. Patients judged as inappropriate for trial entry

Target sample size

53

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	Takeshi Nishi

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

takeshi24@hotmail.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

Date of disclosure of the study information

2014

Year

07

Month

10

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

The prevalence of HPR and the PRU level were significantly lower on prasugrel maintenance therapy compared with the clopidogrel therapy before and after switching.

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

2014

Year

06

Month

17

Day

Date of IRB

Anticipated trial start date

2014

Year

07

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

07

Month

10

Day

Last modified on

2015

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016896