UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012541 |
|---|---|
| Receipt number | R000014678 |
| Scientific Title | A prospective, randomized controlled trial assessing the efficacy and safety of cilostazol and aspirin therapy versus aspirin therapy for the prevention of vascular events in patietns undergoing coronary stent implantation |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2018/06/28 19:13:58 |
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Basic information
Public title
A prospective, randomized controlled trial assessing the efficacy and safety of cilostazol and aspirin therapy versus aspirin therapy for the prevention of vascular events in patietns undergoing coronary stent implantation
Acronym
CATS-I Trial: Cilostazol and Aspirin versus Aspirin Therapy against Vascular Events after Coronary Stent Implantation Trial
Scientific Title
A prospective, randomized controlled trial assessing the efficacy and safety of cilostazol and aspirin therapy versus aspirin therapy for the prevention of vascular events in patietns undergoing coronary stent implantation
Scientific Title:Acronym
CATS-I Trial: Cilostazol and Aspirin versus Aspirin Therapy against Vascular Events after Coronary Stent Implantation Trial
Region
| Japan |
Condition
Condition
Coronary artery disease patients undergoing coronary stent implantation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term efficacy and safety of cilostazol plus aspirin therapy compared with aspirin monotherapy in patients with coronary stent placement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary efficacy endpoint: A composite of all-cause death, myocardial infarction, stroke, or coronary or cerebrovascular revascularization at 2 years after randomization
Primary safety endpoint: Major hemorrhagic events including intracranial hemorrhage at 2 years after randomization
Key secondary outcomes
All-cause death, myocardial infarction, ischemic stroke, hemorrhagic stroke, any coronary revascularization, target lesion revascularization, target vessel revascularization, non-target lesion revascularization, non-target vessel revascularization, any cerebrovascular revascularization, major or minor hemorrhagic events, ankle brachial index, carotid intima-media thickness at 2 years after randomization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
| Medicine |
Interventions/Control_1
All patients were required to be treated with aspirin (100 mg daily indefinitely). Patients in the cilostazol group received 100 mg cilostazol twice daily for 2 years.
Interventions/Control_2
Patients in the aspirin group received 100mg aspirin daily indefinitely.
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
1) Patients who had received coronary stent placement more than 6 months previously and completed angiographic follow-up
2) No indication for further revascularition
3) Written informed consent by the patients
Key exclusion criteria
1) hemostatic disorder or active pathologic bleeding, including hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal bleeding, urinary tract bleeding, hemoptysis and vitreous hemorrhage
2) Known allergy to aspirin or cilostazol
3) Malignancies or other comorbid conditions with a life expectancy of less than 2 years
4) Planned major surgery necessitating discontinuation of antiplatelet therapy within the 2 years after enrollment
5) Pregnancy
6) Circumstances that would have made follow-up impossible
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Nishida |
Organization
Koseikai Takai Hospital
Division name
Cardiovascular Medicine
Zip code
Address
470-8, Kuranosho-Cho, Tenri-City, Nara
TEL
0743-65-5552
nishida@takai-hp.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ueda |
Organization
Koseikai Takai Hospital
Division name
Cardiovascular Meidicine
Zip code
Address
470-8, Kuranosho-Cho, Tenri-City, Nara
TEL
0743-65-5552
Homepage URL
h.ueda998@nifty.com
Sponsor or person
Institute
Koseikai Takai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 12 | Month | 10 | 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
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
Main results already published
Date of protocol fixation
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 28 | 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
| 2013 | Year | 12 | Month | 10 | Day |
Last modified on
| 2018 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014678
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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