NCT07174414

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
60mo left

Started Aug 2026

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

September 12, 2025

Last Update Submit

September 12, 2025

Conditions

Stroke RecurrenceMyocardial InfarctionVascular DeathIschemic StrokeTIA (Transient Ischemic Attack)Stroke (CVA) or Transient Ischemic AttackRecurrent Stroke

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular event (MACE)

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

    Up to 4 years after randomization

Secondary Outcomes (2)

  • Ischemic stroke

    Up to 4 years after randomization

  • Major hemorrhage

    Up to 4 years after randomization

Study Arms (2)

Cilostazol 100mg

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Cilostazol 100 mgDRUG

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.

Cilostazol 100mg
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (9)

  • 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.

    PMID: 29766750BACKGROUND

  • 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.

    PMID: 14641505BACKGROUND

  • 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.

    PMID: 20957133BACKGROUND

  • 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.

    PMID: 25884666BACKGROUND

  • 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.

    PMID: 15654030BACKGROUND

  • 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.

    PMID: 30929256BACKGROUND

  • 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.

    PMID: 34845054BACKGROUND

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

    PMID: 29094912BACKGROUND

  • 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.

    PMID: 30700139BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionIschemic StrokeIschemic Attack, TransientStroke

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Maarten Lansberg, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masked Statistician and Unmasked statistician.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 16, 2025

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)