Health TrialsbyHealthPanel

Cilostazol and Aspirin for Cardiovascular Event Prevention in Patients With Type 2 Diabetes

ConditionsType 2 Diabetes Mellitus (T2DM)Atherosclerosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Bundang Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Carotid intima-media thickness ≥ 1 mm

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

Flow-mediated vasodilatation < 5%

Disqualifiers

Patients with a history of major cardiovascular events, including myocardial infarction, stroke, or heart failure

Patients with heart failure (NYHA I~IV)

Patients with current active bleeding or suspected bleeding

Patients with suspected bleeding tendency or hematologic disorder, such as hemophilia or thrombocytopenia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cilostazol

    Drug

    Drug: Cilostazol Other Name: Pletaal SR Capsule

  • Aspirin

    Drug

    Drug: AspirinOther Name: ASA

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: CilostazolExperimental treatment 1 intervention
Group B: AspirinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)

Incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as myocardial infarction, stroke, cardiac or peripheral revascularization, hospitalization for symptomatic vascular ischemia, amputation, hospitalization for heart failure, or cardiovascular disease-related death

Time frame
Up to 156 weeks

Secondary outcomes

1

Incidence of Three-Point Major Adverse Cardiovascular Events

Incidence of three-point major adverse cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death

Time frame
Up to 156 weeks
2

Incidence of Heart Failure Events

Incidence of heart failure events during the study period

Time frame
Up to 156 weeks
3

Incidence of Peripheral Vascular Events

Incidence of peripheral vascular events, including limb ischemia, amputation, and revascularization.

Time frame
Up to 156 weeks
4

Change in CK-MB Level

Change from baseline in serum creatine kinase-MB level.

Time frame
Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

Source ClinicalTrials.gov
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