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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011353
Receipt No. 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

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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
Email 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
Email totoyota@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of cardiovascular medicine, Kyoto University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013233

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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