UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020332 |
|---|---|
| Receipt number | R000023479 |
| Scientific Title | Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2020/01/20 10:22:52 |
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Basic information
Public title
Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event
Acronym
Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event
(PENDULUM registry)
Scientific Title
Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event
Scientific Title:Acronym
Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event
(PENDULUM registry)
Region
| Japan |
Condition
Condition
Patients with ACS or elective indications undergoing PCI with drug-eluting stent implantation.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of thrombotic and bleeding events following treatment with antiplatelet drugs in Japanese patients undergoing PCI with drug-eluting stent implantation.
To evaluate factors influencing thrombotic and bleeding events in relation to patient background, antiplatelet effect, among others, and to use the results to better inform clinical decision-making to optimize treatment options in relation to patient risk.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy: The incidence of the composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and stent thrombosis at 12 months after index PCI.
Safety: The incidence of major bleeding at 12 months after index PCI. (Major bleeding: BARC type 3 or type 5)
Key secondary outcomes
The incidence of the events listed below within 1 month and 30 months after index PCI.
The incidence of composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis
The incidence of major bleeding.
The incidence of the events listed below within 1 month, 12 months and 30 months after index PCI.
Bleeding event (each category according to BARC criteria; major bleeding and minor bleeding according to TIMI criteria).
Major adverse clinical, cardiac or cerebral events (all-cause death, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, nonfatal ischemic stroke, revascularization (TVR, TLR), TIA, stent thrombosis, and peripheral arterial occlusive disease)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are included in the study if all of the following criteria are met:
1.Patients 20 years of age or older at the time of informed consent
2.Patients who have coronary lesions visually confirmed by coronary angiography and are indicated for PCI with drug eluting stent (patients would be judged by referring package insert.).
3.Patients who are treated with antiplatelet drug(s) after hospitalization to discharge to undergo PCI with drug eluting stent.
4.Patients who agreed to participate in the clinical study after being informed in detail
Key exclusion criteria
Patients are excluded from the study if the following criteria is met:
Patients who are in or plan to participate in such clinical study/ research before the end of follow-up in this study.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nakamura |
Organization
Toho University Ohashi Medical Center
Division name
Division of Cardiovascular Medicine
Zip code
Address
2-7-6 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
masato@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Odani |
Organization
CMIC Co., Ltd.
Division name
Academia Clinical Research Div.
Zip code
Address
Hamamatsucho Bldg., 1-1-1 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-6779-8172
Homepage URL
masashi-odani@cmic.co.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Daiichi Sankyo Co., LTD
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 | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
6422
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
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 31 | 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
This trial is a non-randomised, prospective registry study.
In principal, investigators will obtain informed consent from patients or their legally acceptable representatives before index PCI, and they will consecutively enroll patients who meet the inclusion criteria, but not the exclusion criteria.
Management information
Registered date
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023479
