UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017732 |
|---|---|
| Receipt number | 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 21:40:21 |
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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
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
k-tsuka@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university medical center
Cardiovascular center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020472
