UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yasunori Nishida
Organization	Koseikai Takai Hospital
Division name	Cardiovascular Medicine
Address	470-8, Kuranosho-Cho, Tenri-City, Nara
TEL	0743-65-5552
Email	nishida@takai-hp.com

Public contact
Name of contact person	Hiroshi Ueda
Organization	Koseikai Takai Hospital
Division name	Cardiovascular Meidicine
Address	470-8, Kuranosho-Cho, Tenri-City, Nara
TEL	0743-65-5552
Homepage URL
Email	h.ueda998@nifty.com

Sponsor
Institute	Koseikai Takai Hospital
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014678