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Comparison of Efficacy and Safety Between Aspirin and Cilostazol on Cardiovascular Event in Patients at High Risk of Cardiovascular Disease, Randomization.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Patients with type 2 diabetes and cardiovascular risk factors are at increased risk of cardiovascular events. Therefore, a multi-center prospective randomized study will be conducted to compare the efficacy and safety of cilostazol and aspirin for the prevention of major adverse cardiac and cerebrovascular events (MACCE) in high-risk patients with type 2 diabetes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Individuals with type 2 diabetes mellitus were eligible if they were aged ≥19 years

• Individuals with subclinical atherosclerosis or metabolic syndrome, defined as at least one of the following:

• Carotid intima-media thickness ≥ 1 mm

• Ankle-brachial index \< 0.9 - Pulse wave velocity ≥ 9 m/s

• Flow-mediated vasodilatation \< 5%

• Coronary artery calcium score ≥ 40

• Coronary artery stenosis ≥ 20% or ≤ 70%

• Peripheral artery occlusive disease ≥ 20%

• Metabolic syndrome

• Individuals with HbA1c ≤ 9.9%

• Individuals who voluntarily agree to participate in the study and provide written informed consent

Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Soo Lim
limsoo@snu.ac.kr
82-10-9766-2706
Backup
Jiyoon Lee
rq857@snubh.org
82-10-4850-4828
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1200
Treatments
Experimental: Cilostazol
Active_comparator: Aspirin
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Bundang Hospital

This content was sourced from clinicaltrials.gov