UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011353 |
|---|---|
| Receipt number | R000013233 |
| Scientific Title | Single use of ADP receptor antagonists in patients taKIng oral anticoagulants undergoing Percutaneous coronary intervention: Is ASpirin nessesAry? |
| Date of disclosure of the study information | 2013/09/15 |
| Last modified on | 2014/08/04 13:15:48 |
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Basic information
Public title
Single use of ADP receptor antagonists in patients taKIng oral anticoagulants undergoing Percutaneous coronary intervention: Is ASpirin nessesAry?
Acronym
SKIP-ASA
Scientific Title
Single use of ADP receptor antagonists in patients taKIng oral anticoagulants undergoing Percutaneous coronary intervention: Is ASpirin nessesAry?
Scientific Title:Acronym
SKIP-ASA
Region
| Japan |
Condition
Condition
indications for oral anticoagulants
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of clopidogrel-only antiplatelet therapy in patients with oral anticoagulant therapy after percutaneous coronary intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endpoint of all-cause death, myocardial infarction, stent thrombosis, and stroke.
Major bleeding (BARC Type 3 or 5).
Key secondary outcomes
All-cause death, myocardial infarction, stroke, stent thrombosis, coronary revascularization, admission by angina pectoris, and admission by heart failure.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Perform single use of ADP receptor antagonists in patients taking oral anticoagulants undergoing coronary stenting.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients sheduled for percutaneous coronary intervention.
2) Patients taking oral anticoagulants and patients start oral anticoagulant therapy after percutaneous coronary intervention.
Key exclusion criteria
1) Contraindication of ADP receptor antagonists.
2) Pregnant women, women suspected of being pregnant, and breast-feeding women.
3) Judged as ineligible for enrollment by clinical investigators.
4) Past medical history of stent thrombosis.
5) Patients who cannot change current antiplatelet agents, including aspirin, cilostazol, and ticlopidine.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
54 Shougoin-kawaharamachi, Sakyo-ku, Kyoto, Japan
TEL
0757514255
totoyota@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Toyota |
Organization
Kyoto University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
54 Shougoin-kawaharamachi, Sakyo-ku, Kyoto, Japan
TEL
0757514255
Homepage URL
totoyota@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of cardiovascular medicine, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of cardiovascular medicine, Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding 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
| 2013 | Year | 09 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 15 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2014 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013233
