UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029729
Receipt No. R000033968
Scientific Title Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Date of disclosure of the study information 2017/12/01
Last modified on 2019/04/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Acronym Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Scientific Title Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Scientific Title:Acronym Correlation between High Platelet Reactivity with Loading Dose of Prasugrel and Clinical Outcome in the Patients with Acute Coronary Syndrome
Region
Japan

Condition
Condition acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the correlation between HPR in the early phase of ACS with loading dose of prasugrel and clinical outcome
Basic objectives2 Others
Basic objectives -Others Evaluation of pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes composite of all death, myocardial death, myocardial infarction, stroke, ventricular arrhythmia needing defibrillation, cardiac rupture and serious hemorrhage within 30 days of onset

Key secondary outcomes composite of all death, myocardial death, myocardial infarction, stroke, heart-failure hospitalization, target lesion revascularization and serious hemorrhage within one year of onset


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Prasugrel 20mg
Interventions/Control_2
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 (a) patients with acute coronary syndrome to whom emergent PCI is planned.
(b)patients aged over 20 and under 90 years old.
Key exclusion criteria (a) patients wiht bleeding tendency
(b) patients with allagy against thienopyridine drugs
(c)patients who are not suitable for this study
Target sample size 100

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, Omote-cho, Kitanagase, Okayama 700-8557, 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, Omote-cho, Kitanagase, Okayama 700-8557, Japan
TEL 086-737-3000
Homepage URL
Email jamkuhta@yahoo.co.jp

Sponsor
Institute Okayama City Hospital
Institute
Department

Funding Source
Organization Cardiovascular Medicine,Okayama University Hospital
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 3-20-1, Omote-cho, Kitanagase, Okayama 700-8557, Japan
Tel 086-737-3000
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 12 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 26 Day
Date of IRB
2017 Year 11 Month 01 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 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 10 Month 26 Day
Last modified on
2019 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033968

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.