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

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 - CATS-I Trial: Cilostazol and Aspirin versus Aspirin Therapy against Vascular Events after Coronary Stent Implantation Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012541

Enrollment

700

Registered

2013-12-10

Start date

2008-05-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease patients undergoing coronary stent implantation

Interventions

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. Patients in the aspirin group re

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHiroshi Ueda

Koseikai Takai Hospital Cardiovascular Meidicine

h.ueda998@nifty.com0743-65-5552

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026