UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of clopidogrel and prasugrel as prophylaxis for In-stent protrusion evaluated by optical coherence tomography in patients with ST-segment elevation myocardial infarction
Title of the study (Brief title)	INSPECT-MI
Region	Japan

Condition
Condition	ST-segment elevation myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate in-stent protrusion volume evaluated by optical coherence tomography (OCT) 14 days after undergoing primary-PCI with stenting in patients with ST-segment elevation myocardial infarction who receive prasugrel or clopidogrel
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	In-stent protrusion volume with stent-length correction, evaluated by OCT 14 days after primary PCI
Key secondary outcomes	*Median variation of in-stent protrusion volume evaluated by OCT * Median PRU value (or % inhibition) assessed with VerifyNow-P2Y12 assay 1 hour after a loading dose of prasugrel or clopidogrel * Median variation of PRU value (or % inhibition) using with VerifyNow-P2Y12 assay during treatment period * Median variation of AUC (or occlusion time) evaluated with T-TAS system during treatment period * Frequency of 30-day adverse cardiovascular events (including all-cause death, re-infarction, heart failure, target vessel revascularization, stent thrombosis)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients were randomly assigned by computer-generated randomization sequence to receive prasugrel. Prasugrel treatment was started with a loading dose of 20mg orally before stent implantation, followed by a maintenance dose of 3.75mg once daily (2.5mg once daily for patients with high risk of hemorrhagic complication) in addition to aspirin 100mg once daily for at least 30 days.
Interventions/Control_2	Patients were randomly assigned by computer-generated randomization sequence to receive clopidogrel. Clopidogrel treatment was started with a loading dose of 300mg orally before stent implantation, followed by a maintenance dose of 75mg once daily (50mg once daily for patients with high risk of hemorrhagic complication) in addition to aspirin 100mg once daily for at least 30 days.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ST-segment elevation myocardial infarction (STEMI) within 12 hours from symptom onset who are scheduled to undergo coronary stent implantation are enrolled.
Key exclusion criteria	(1)Use of oral anticoagulants, ticlodipine, cilostazol and clopidogrel (2)Cardiopulmonary arrest or prolonged CPR (3)Cardiogenic shock (4)STEMI caused by coronary artery bypass graft disease or in-stent restenosis (5)Unsuitable for stent implantation (6)Severe chronic renal failure with serum creatinine >2mg/dL (7)Left main trunk disease (8) Serum hemoglobin level < 9g/dL or >18g/dL Platelet count < 50,000 /mm3 or > 500,000 /mm3 (9) Hematologic or malignant disorder with the life expectancy < 1 year (10)Major bleeding events within 7 days before enrollment (11) Severe liver dysfunction (hepatic cirrhosis or portal hypertension) (12)Drug allergy to aspirin, clopidogrel or prasugrel (13)Women of pregnant, childbearing potential or lactation (14)Participating in the other trial (phase 1-3) (15)Patients who are not allowed to participate in the trial by judgement of the treating physician
Target sample size	50

Research contact person
Name of lead principal investigator	Kazuo Kimura
Organization	Yokohama city univercity medical center
Division name	Cardiovascular center
Address	4-57,urafune-cho,minami-ku,Yokohama
TEL	045-261-5656
Email	c-kimura@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	Kengo Tsukahara
Organization	Yokohama city university medical center
Division name	Cardiovascular center
Address	4-57,urafune-cho,minami-ku,Yokohama
TEL	045-261-5656
Homepage URL
Email	k-tsuka@urahp.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university medical center Cardiovascular center
Institute
Department

Funding Source
Organization	DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2015 Year 05 Month 29 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 01 Month 27 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 28 Day
Last modified on	2016 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020472