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Not yet recruitingNCT07174414ClarityUpdated Sep 16, 2025

Cilostazol for Prevention of Recurrent Stroke Trial

A Phase 3 interventional study of Cilostazol 100 mg and Placebo in Stroke Recurrence, Myocardial Infarction and Vascular Death, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Stanford University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Stroke Recurrence
  • Myocardial Infarction
  • Vascular Death
  • Ischemic Stroke
  • TIA (Transient Ischemic Attack)
  • Stroke (CVA) or Transient Ischemic Attack
  • Recurrent Stroke
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Had a spontaneous brain bleed within the last 2 years.
  • Moderate to severe heart failure.
  • Life expectancy is less than 6 months.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Cilostazol 100 mg

  • Placebo comparator
    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.

    Drug: Placebo

Interventions

  • DrugCilostazol 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.

  • DrugPlacebo

    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.

05

What researchers measure

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

06

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
07

References and documents

Publications

  • 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. PubMed 29766750 ↗
  • 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. PubMed 14641505 ↗
  • 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. PubMed 20957133 ↗
  • 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. PubMed 25884666 ↗
  • 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. PubMed 15654030 ↗
  • 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. PubMed 30929256 ↗
  • 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. PubMed 34845054 ↗
  • Oza R, Rundell K, Garcellano M. Recurrent Ischemic Stroke: Strategies for Prevention. Am Fam Physician. 2017 Oct 1;96(7):436-440. PubMed 29094912 ↗
  • 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. PubMed 30700139 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07174414
Lead sponsor
Stanford University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Yale University, University of Cincinnati, Medical University of South Carolina
Responsible party
Maarten Lansberg (Professor of Neurology, Stanford University) — Principal investigator
First posted
Sep 16, 2025
Start date
Aug 2026 (estimated)
Primary completion
Jul 2031 (estimated)
Completion
Jul 2031 (estimated)
Last update
Sep 16, 2025

Study contacts

Maarten Lansberg, MD, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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