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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017732
Receipt No. R000020472
Scientific Title Comparison of clopidogrel and prasugrel as prophylaxis for In-stent protrusion evaluated by optical coherence tomography in patients with ST-segment elevation myocardial infarction
Date of disclosure of the study information 2015/05/29
Last modified on 2016/12/21

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Basic information
Public title Comparison of clopidogrel and prasugrel as prophylaxis for In-stent protrusion evaluated by optical coherence tomography
in patients with ST-segment elevation myocardial infarction
Acronym INSPECT-MI
Scientific Title Comparison of clopidogrel and prasugrel as prophylaxis for In-stent protrusion evaluated by optical coherence tomography
in patients with ST-segment elevation myocardial infarction
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo Kimura
Organization Yokohama city univercity medical center
Division name Cardiovascular center
Zip code
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
1st name
Middle name
Last name Kengo Tsukahara
Organization Yokohama city university medical center
Division name Cardiovascular center
Zip code
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)

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
2015 Year 05 Month 29 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 No longer recruiting
Date of protocol fixation
2015 Year 01 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020472

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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