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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027582
Receipt No. R000031586
Scientific Title The relation between increased platelet reactivity during PCI and peri-procedural myocardial injury: comparison of clopidogrel with prasugrel
Date of disclosure of the study information 2017/10/01
Last modified on 2019/06/02

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Basic information
Public title The relation between increased platelet reactivity during PCI and peri-procedural myocardial injury: comparison of clopidogrel with prasugrel
Acronym The relation between increased platelet reactivity during PCI and peri-procedural myocardial injury
Scientific Title The relation between increased platelet reactivity during PCI and peri-procedural myocardial injury: comparison of clopidogrel with prasugrel
Scientific Title:Acronym The relation between increased platelet reactivity during PCI and peri-procedural myocardial injury
Region
Japan

Condition
Condition effort angina
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the platelet reactivity during PCI and the occurrence of PMI between patients with clopidogrel and prasugrel.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the occurrence rate of PMI
(definition of PMI)
High-sensitive Troponin-T (hs-TnT) was measured before and 24 hours after PCI. In patients with normal (<99th percentile URL) baseline hs-TnT concentrations, PMI was defined as elevation of hs-TnT >5*99th percentile URL 24 hours after PCI. If the baseline hs-TnT values are elevated and are stable or falling, then a rise of > 20% is required for the diagnosis of PMI.
Key secondary outcomes PRU value before and after PCI.
the serial change in platelet reactivity during elective PCI.
the correlation between the occurrence of PMI and PRU value before PCI and after PCI.
cardiovascular event and hemorrhagic event within 30 days after PCI.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients in clopidogrel group underwent dual anti-platelet therapy with clopidogrel (75 mg daily) and aspirin (100 mg daily) between 7 days before PCI and 30 days after PCI.
Interventions/Control_2 Patients in prasugrel group underwent dual anti-platelet therapy with prasugrel (3.75 mg daily) and aspirin (100 mg daily) between 7 days before PCI and 30 days after PCI.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with effort angina scheduled for elective PCI.
Key exclusion criteria hemorrhagic tendency
severe liver dysfunction(child-pugh grade C)
severe renal dysfunction (eGFR <30mL/min/1.73m2)
severe hypertension (systolic blood pressure >180)
have past history of cerebral infarction or transient ischemic attack
have intolerance with other thienopyridine derivative

Target sample size 160

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Kawai
Organization Okayama City Hospital
Division name Department of Cardiovascular Medicine
Zip code 700-8557
Address 3-20-1 Kitanagaseomote-cho Kita-ku Okayama, Japan
TEL 086-737-3000
Email jamkuhta@yahoo.co.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Kawai
Organization Okayama City Hospital
Division name Department of Cardiovascular Medicine
Zip code 700-8557
Address 3-20-1 Kitanagaseomote-cho Kita-ku Okayama, Japan
TEL 086-737-3000
Homepage URL
Email jamkuhta@yahoo.co.jp

Sponsor
Institute Okayama City Hospital
Institute
Department

Funding Source
Organization Okayama University Hospital, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama City Hospital
Address 700-8557 3-20-1 Kitanagaseomote-cho Kita-ku Okayama, Japan
Tel 0867373000
Email jamkuhta@yahoo.co.jp

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
2017 Year 10 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 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
2017 Year 05 Month 31 Day
Last modified on
2019 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031586

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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