UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023756
Receipt number R000027371
Scientific Title Vascular function and Antiplatelet effects on switching from Clopidgrel to Prasugrel in chronic phase after percutaneous coronary intervention
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/25 00:37:40

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Basic information

Public title

Vascular function and Antiplatelet effects on switching from Clopidgrel to Prasugrel in chronic phase after percutaneous coronary intervention

Acronym

Switch-Pras study

Scientific Title

Vascular function and Antiplatelet effects on switching from Clopidgrel to Prasugrel in chronic phase after percutaneous coronary intervention

Scientific Title:Acronym

Switch-Pras study

Region

Japan


Condition

Condition

The patients on DAPT after PCI who underwent follow-up coronary angiography

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Platelet Reactivity after switching from Clopidgrel with Aspirin to Prasugrel with Aspirin in patients who underwent PCI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of change on PRU from baseline to observation point(6M+-3M) between Clopidgrel with Aspirin and Prasugrel with Aspirin

Key secondary outcomes

1:The effect of CYP2C19 polymorphism against the PRU from baseline to observation point between Clopidgrel with Aspirin and Prasugrel with Aspirin

2:Quantitative change on FMD from baseline to observation point between Clopidgrel with Aspirin and Prasugrel with Aspirin

3:Quantitative change on RHI from baseline to observation point between Clopidgrel with Aspirin and Prasugrel with Aspirin

4:Quantitative change and rate of change on Inflammatory biomarkers from baseline to observation point between Clopidgrel with Aspirin and Prasugrel with Aspirin

5:Quantitative change on CD34+/CD133+/CD45low cells from baseline to observation point between Clopidgrel with Aspirin and Prasugrel with Aspirin


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Clopidgrel with Aspirin group
Aspirin is 81mg X1
Clopidgrel is 75mg X1

Interventions/Control_2

Prasugrel with Aspirin group
Aspirin is 81mg X1
Prasugrel is 3.75mg X1

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1:The patients on DAPT after PCI who underwent follow-up coronary angiography

2:Patients agreening with this study after informed consent

Key exclusion criteria

1:Ptients who has high risk for bleeding

2:Patients with heart Valve Disease and congenital heart disease

3:Patients with cerebrovascular disease

4:Patients who have infection or Inflammatory disease

5:Patients with malignant neoplasm

6:CKD <G4 eGFR<30(ml/min/1.7m2)

7:Patients with allergy against thienopyridines

8:Patients undergoing anticoagulation therapy

9:Patients who are not suitable for this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teruo Inoue

Organization

Dokkyo Medical University

Division name

Cardiovascular Medicine

Zip code


Address

880 Kitakobayashi Mibu Tochigi

TEL

0282-86-1111

Email

inouet@dokkyomed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi Sakuma

Organization

Dokkyo Medical University

Division name

Cardiovascular Medicine

Zip code


Address

880 Kitakobayashi Mibu Tochigi

TEL

0282-86-1111

Homepage URL


Email

masakuma@dokkyomed.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine,Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

nothing

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Date of protocol fixation

2015 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 25 Day

Last modified on

2016 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027371


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name