Cilostazol for Prevention of Recurrent Stroke Trial

NCT ID: NCT07174414

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-31

Study Completion Date

2031-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Recurrence Myocardial Infarction Vascular Death Ischemic Stroke TIA (Transient Ischemic Attack) Stroke (CVA) or Transient Ischemic Attack Recurrent Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Masked Statistician and Unmasked statistician.

Study Groups

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Cilostazol 100mg

Participants take oral cilostazol until a study endpoint occurs, they reach maximum follow up duration (4 years), the participant withdraws, or the study ends.

Group Type EXPERIMENTAL

Cilostazol 100 mg

Intervention Type 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

Participants take oral placebo until a study endpoint occurs, they reach maximum follow up duration (4 years), the participant withdraws, or the study ends.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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Cilostazol 100 mg

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Had a spontaneous brain bleed within the last 2 years.
* Moderate to severe heart failure.
* Life expectancy is less than 6 months.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Maarten Lansberg

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maarten Lansberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.

Reference Type BACKGROUND
PMID: 29766750 (View on PubMed)

Spieler JF, De Pouvourville G, Amarenco P. Cost of a recurrent vs. cost of first-ever stroke over an 18-month period. Eur J Neurol. 2003 Nov;10(6):621-4. doi: 10.1046/j.1468-1331.2003.00665.x.

Reference Type BACKGROUND
PMID: 14641505 (View on PubMed)

Engel-Nitz NM, Sander SD, Harley C, Rey GG, Shah H. Costs and outcomes of noncardioembolic ischemic stroke in a managed care population. Vasc Health Risk Manag. 2010 Oct 5;6:905-13. doi: 10.2147/VHRM.S10851.

Reference Type BACKGROUND
PMID: 20957133 (View on PubMed)

Serena J, Segura T, Roquer J, Garcia-Gil M, Castillo J; ARTICO Study. The ARTICO study: identification of patients at high risk of vascular recurrence after a first non-cardioembolic stroke. BMC Neurol. 2015 Mar 11;15:28. doi: 10.1186/s12883-015-0278-4.

Reference Type BACKGROUND
PMID: 25884666 (View on PubMed)

Nedeltchev K, der Maur TA, Georgiadis D, Arnold M, Caso V, Mattle HP, Schroth G, Remonda L, Sturzenegger M, Fischer U, Baumgartner RW. Ischaemic stroke in young adults: predictors of outcome and recurrence. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):191-5. doi: 10.1136/jnnp.2004.040543.

Reference Type BACKGROUND
PMID: 15654030 (View on PubMed)

Khanevski AN, Bjerkreim AT, Novotny V, Naess H, Thomassen L, Logallo N, Kvistad CE; NOR-STROKE study group. Recurrent ischemic stroke: Incidence, predictors, and impact on mortality. Acta Neurol Scand. 2019 Jul;140(1):3-8. doi: 10.1111/ane.13093. Epub 2019 Apr 11.

Reference Type BACKGROUND
PMID: 30929256 (View on PubMed)

Skajaa N, Adelborg K, Horvath-Puho E, Rothman KJ, Henderson VW, Thygesen LC, Sorensen HT. Risks of Stroke Recurrence and Mortality After First and Recurrent Strokes in Denmark: A Nationwide Registry Study. Neurology. 2022 Jan 24;98(4):e329-e342. doi: 10.1212/WNL.0000000000013118.

Reference Type BACKGROUND
PMID: 34845054 (View on PubMed)

Oza R, Rundell K, Garcellano M. Recurrent Ischemic Stroke: Strategies for Prevention. Am Fam Physician. 2017 Oct 1;96(7):436-440.

Reference Type BACKGROUND
PMID: 29094912 (View on PubMed)

Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.

Reference Type BACKGROUND
PMID: 30700139 (View on PubMed)

Other Identifiers

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1UG3NS133209-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

82476

Identifier Type: -

Identifier Source: org_study_id

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