What side effects are associated with this type of intervention?

Common treatments for Cerebral Small Vessel Disease (SVD) include antiplatelet agents like cilostazol, which also has vasodilatory and anti-inflammatory properties. Known side effects of cilostazol include headache, diarrhea, dizziness, and palpitations. Other antiplatelet agents, such as aspirin and clopidogrel, can cause gastrointestinal issues, bleeding, and, in some cases, increased risk of hemorrhage. Vasodilators may lead to headaches, flushing, and hypotension. Anti-inflammatory drugs can cause gastrointestinal discomfort and increased risk of bleeding. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

There are currently no FDA-approved treatments specifically for Cerebral Small Vessel Disease (SVD). Cilostazol, an antiplatelet agent with vasodilatory and anti-inflammatory properties, is being studied for its potential benefits in treating SVD. This study aims to evaluate cilostazol's efficacy and safety, but no definitive FDA-approved treatments for SVD have been established yet.

What other types of research exist?

Promising novel alternatives to Cilostazol for Cerebral Small Vessel Disease patients include: 1) Inclisiran, which has shown significant LDL-C reduction and potential vascular benefits in the ORION trials. 2) Selexipag, a selective prostacyclin receptor agonist, which has demonstrated efficacy in pulmonary arterial hypertension and may offer vasodilatory benefits. 3) Rivaroxaban, an oral anticoagulant, which has shown positive outcomes in patients with stable cardiovascular disease and may provide antiplatelet effects.

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Antiplatelet Agent

Cilostazol for Cerebral Small Vessel Disease

Phase 1 & 2

Recruiting

Led By Michelle P Lin, MD, MPH

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 yo.

Be older than 18 years old

Must not have

Age<18yo

Unable to follow commands

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test cilostazol, a medication that prevents blood clots and improves blood flow, in older adults with cerebral small vessel disease (SVD). The study will evaluate if cilostazol can slow the progression of SVD by improving blood flow and reducing inflammation. Participants will undergo various tests to measure changes in their condition over time.

Who is the study for?

This trial is for adults over 18 with cerebral small vessel disease (SVD) conditions like CADASIL or sporadic white matter diseases, and also includes healthy controls without SVD. It's not open to those under 18, pregnant or breastfeeding individuals, people who can't follow commands, or those unable to tolerate an MRI.

What is being tested?

The study tests if cilostazol, a drug that prevents blood clots and widens blood vessels, can slow down the progression of SVD—a brain condition linked to stroke and dementia—and if changes in retina blood flow are indicators of SVD health.

What are the potential side effects?

Cilostazol may cause headaches, diarrhea, palpitations (feeling your heart beat), dizziness when standing up too fast due to low blood pressure, and unusual bleeding or bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I cannot follow instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

white matter disease volume

Secondary study objectives

cerebrovasoreactivity

cognition

retinal vasoreactivity

+1 more

Side effects data

From 2009 Phase 4 trial • 457 Patients • NCT00130039

73%

others

27%

headache

12%

dizziness

diarrhea

epigastric soreness

cerebral infarction

depression

palpitation

gastroenteritis

fracture or other joint pain

acute myocardial infarction

cancer

aneurysm unruptured

GI bleeding

diabetes complications

edema

urticaria

GI bleedings

tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Cilostazol

Clopidogrel

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CilostazolExperimental Treatment1 Intervention

Cilostazol 100mg BID

Group II: No interventionActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cilostazol

2012

Completed Phase 4

~6360

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cerebral Small Vessel Disease (SVD) include antiplatelet, vasodilatory, and anti-inflammatory agents. Cilostazol, an antiplatelet agent, prevents blood clots by inhibiting platelet aggregation, reducing the risk of ischemic events. Its vasodilatory properties help widen blood vessels, improving blood flow and reducing vascular resistance. Additionally, its anti-inflammatory effects reduce inflammation in the blood vessels, preventing further vascular damage. These mechanisms are vital for SVD patients as they address the underlying vascular issues, potentially slowing disease progression and reducing the risk of severe outcomes like stroke and dementia.

Pentoxifylline in the treatment of acute ischaemic stroke--a reappraisal in Chinese stroke patients.Dual Antiplatelet Therapy Using Cilostazol With Aspirin or Clopidogrel: Subanalysis of the CSPS.com Trial.Treatment with cilostazol improves clinical outcome after endovascular therapy in hemodialysis patients with peripheral artery disease.