UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 05 Month 29 Day
Date of IRB	2017 Year 05 Month 26 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
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 12 Month 03 Day

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