Cilostazol for Prevention of Recurrent Stroke Trial

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorStanford University

About this trial

The goal of this clinical trial is to learn whether adding cilostazol to aspirin or clopidogrel prevents stroke and heart attack in people who have had a stroke or mini-stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of stroke or mini-stroke (also called TIA) within the last 180 days

Currently taking aspirin or clopidogrel (not both) to prevent another stroke

Disqualifiers

Had a spontaneous brain bleed within the last 2 years.

Moderate to severe heart failure.

Life expectancy is less than 6 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cilostazol 100 mg

    Drug

    Cilostazol 100 mg tablet taken orally twice daily following an initial 2-week period during which cilostazol is dosed at 100 mg tablet taken orally once daily to maximize tolerability.

  • Placebo

    Drug

    Placebo 100 mg tablet twice taken orally daily following an initial 2-week period during which placebo is dosed at 100 mg taken orally once daily to maximize tolerability.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Cilostazol 100mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular event (MACE)

Time to stroke (ischemic and hemorrhagic), acute myocardial infarction, or vascular death

Time frame
Up to 4 years after randomization

Secondary outcomes

1

Ischemic stroke

Time to ischemic stroke

Time frame
Up to 4 years after randomization
2

Major hemorrhage

Time to major hemorrhage

Time frame
Up to 4 years after randomization

Other outcomes

Sponsors and contacts

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Stanford University

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Yale University

Collaborator

University of Cincinnati

Collaborator

Medical University of South Carolina

Collaborator

This trial is not recruiting at the moment. You can still explore other options: