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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017624 |
Receipt No. | R000018136 |
Scientific Title | Platelet response to prasugrel and clopidogrel loadinig doses in elective PCI patients |
Date of disclosure of the study information | 2015/05/21 |
Last modified on | 2018/03/07 |
Basic information | ||
Public title | Platelet response to prasugrel and clopidogrel loadinig doses in elective PCI patients | |
Acronym | Comparison of platelet responses to different thienopyridines | |
Scientific Title | Platelet response to prasugrel and clopidogrel loadinig doses in elective PCI patients | |
Scientific Title:Acronym | Comparison of platelet responses to different thienopyridines | |
Region |
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Condition | ||
Condition | Elective PCI | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | To determine appropriate administration method of thienopyridine in Japanese patients undergoing elective percutaneous coronary intervention by comparing platelet function. |
Basic objectives2 | Others |
Basic objectives -Others | To identify independent variables to affect platelet responses to thieonopyridines. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Responses of platelets to the treatment with prasugrel and clopidogrel.
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Key secondary outcomes | To investigate the frequency of bleeding complication such as gross hematuria,subcutaneous bleeding,hemoglobin change after percutaneous coronary intervention. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | prasugrel group | |
Interventions/Control_2 | clopidogrel group | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1)Stable angina pectoris patient scheduled for elective coronary artery stenting.
(2)Patient who takes aspirin. (3)One of the tests (cardiac computed tomography, stress technetium myocardial scintigraphy, exercise tredmil test) is positive. (4)Patient who give informed consent to this study. |
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Key exclusion criteria | (1)Concomitant use of other antiplatelet drugs other than aspirin.
(2)Participation in other clinical trial. (3)Platelet counts of <10x107/ml or >40x107/ml (4)Malignant disease or autoimmune disease. (5)Judgment by physician that a patient is inappropriate to enroll the study. (6)Patient who have communication difficulty. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Jichi Medical University School of Medicine | ||||||
Division name | Division of Cardiovascular Medicine | ||||||
Zip code | |||||||
Address | 3311-1, Yakushiji, Shimotsuke, Tochigi | ||||||
TEL | 0285-44-2111 | ||||||
kkario@jichi.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Jichi Medical University School of Medicine | ||||||
Division name | Division of Cardiovascular Medicine | ||||||
Zip code | |||||||
Address | 3311-1, Yakushiji, Shimotsuke, Tochigi | ||||||
TEL | 0285-44-2111 | ||||||
Homepage URL | |||||||
r0742sn@jichi.ac.jp |
Sponsor | |
Institute | Division of Cardiovascular Medicine, Jichi Medical University School of Medicine |
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 | |
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 |
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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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018136 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |