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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023756
Receipt No. 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

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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
Last 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
1st 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
Institute Department of Cardiovascular Medicine,Dokkyo Medical University
Institute
Department

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
URL(English) https://upload.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


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