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

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 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


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

Value
https://center6.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