Stroke RecurrencePhase 3ClarityNCT07174414
Cilostazol for Prevention of Recurrent Stroke Trial
A Phase 3 study testing Cilostazol 100 mg Tablets in people with Stroke Recurrence and Myocardial Infarction, run by Stanford University at 46 sites in United States.
Trial summary
The goal of this clinical study is to learn if adding a medicine called cilostazol to usual treatment can help prevent another stroke, a heart attack, or death in patients who had a stroke caused by a blocked blood vessel, or a "mini-stroke" (also called a TIA), in the past 6 months. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke Recurrence, Myocardial Infarction, Vascular Death
- What is being tested?
- Cilostazol 100 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 46 sitesUnited States
- Study dates
- Oct 2026to Jul 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥40 years
- Ischemic stroke or high-risk TIA (ABCD2 score ≥6)
- Can be randomized within 180 days after ischemic stroke or high-risk TIA
- Treatment with single or dual antithrombotic therapy with aspirin, clopidogrel and/or ticagrelor per international and/or national guidelines
- Two or more of the following risk factors: age 65 years or older, hypertension, diabetes mellitus, history of ischemic stroke other than the qualifying event for this trial, currently smoking, peripheral arterial disease, coronary artery disease including prior MI, aortic atherosclerotic plaque ≥4 mm, ≥50% stenosis or occlusion of a major intracranial artery (ICA, M1, M2, A1, P1, vertebral, or basilar) or extracranial artery (ICA or vertebral)
- In the opinion of the site investigator, patient is medically stable, capable of participating in the trial, and willing and able to attend follow-up
- Able to receive study drug by mail and able to begin taking study drug promptly after receipt
- Provision of signed and dated informed consent form by patient or legally authorized representative
Who cannot join
- Atrial fibrillation, mechanical heart valve, or left ventricular assist device
- Use of prohibited medication (as specified in the MOP)
- Modified Rankin Scale 5
- Planned cardiac surgery, percutaneous coronary intervention, carotid endarterectomy or stenting (patients are eligible post-procedure)
- History of symptomatic non-traumatic intracerebral hemorrhage within last 2 years
- Known thrombocytopenia (platelet count ≤100,000 per microliter (µL))
Show all 14Show fewer
- Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C)
- Pregnant, breast-feeding, or of child-bearing potential but not on birth control
- Confirmed diagnosis of heart failure with current or prior symptoms or signs (e.g. paroxysmal nocturnal dyspnea, reduced exercise tolerance, ankle swelling, elevated jugular venous pressure)
- Hypersensitivity to cilostazol or any component of the formulation (e.g. anaphylaxis, angioedema)
- Currently enrolled in an investigational intervention study
- Life expectancy less than 6 months
- Participant does not allow contacting of their surrogate (e.g. family member or friend) or health care practitioner to obtain health information should participant become unwilling or unable to follow the study schedule.
- Participants who are incarcerated, including prisoners or participants compulsorily detained for treatment of psychiatric disease.
Trial locations and contacts
46 sites in 1 country. Contact the study team or a site near you to ask about taking part.
46 sites in 1 country
United States46 sites
Cleveland Clinic Akron General
Akron, Ohio, 44307
Debra Hudock, 330 289 8605, hudockd@ccf.org
University of Michigan - University Hospital
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30303
Alicia E Moore, 404-778-8239, amescob@emory.edu
Grady Memorial Hospital
Atlanta, Georgia, 30303
Alicia E Moore, 404-778-8239, amescob@emory.edu
University of Maryland Medical Center
Baltimore, Maryland, 21201
Beata Assadi, 410-328-5532, BAssadi@som.umaryland.edu
University of Alabama Hospital - Birmingham
Birmingham, Alabama, 35249
Sarah Bruton, 205-975-8569, sjbruton@uabmc.edu
Boston Medical Center
Boston, Massachusetts, 02118
Robert Araujo-conteras, 617-638-5339, robert.araujocontreras@bmc.org
Kings County Hospital Center
Brooklyn, New York, 11203
Sarah Hobbs, 973-780-7242, hobbss3@nychhc.org
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220
Maria Cotrina-Vidal, 718-630-8442, Maria.Cotrina@nyulangone.org
Memorial Hospital of Carbondale
Carbondale, Illinois, 62901
Heather von Hagn, 618-351-4972, heather.vonhagn@sih.net
Chandler Regional Medical Center
Chandler, Arizona, 85224
Aaliyah Dean, 480-601-5411, aaliyah.dean@commonspirit.org
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425
Caitlan LeMatty, 843-792-8606, lemattyc@musc.edu
UVA Medical Center
Charlottesville, Virginia, 22908
Miah Perch, 434-924-2617, pgq8ja@uvahealth.org
University of Cinncinati
Cincinnati, Ohio, 45267
Ranjaka Gunawardena, 513-884-3260, gunawad@ucmail.uc.edu
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Georgia Taylor, 803-331-2467, georgia.taylor@prismahealth.org
Duke University Hospital
Durham, North Carolina, 27710
Megan Gonzalez, 919-660-4131, megan.gonzalez@duke.edu
UPMC Hamot
Erie, Pennsylvania, 16550
Brandi Ouellette, 814 877 2082, salvatorebr3@upmc.edu
Mclaren Flint
Flint, Michigan, 48532
Marci Roberts, 810-342-4071, marci.roberts@mclaren.org
University of Iowa Medical Center
Iowa City, Iowa, 52242
Heena Olalde, 319-356-8326, heena-olalde@uiowa.edu
UF Health Jacksonville
Jacksonville, Florida, 32209
Yasmeen Shabbir, 904-244-9856, yasmeen.shabbir@jax.ufl.edu
University of Kansas Hospital
Kansas City, Kansas, 66160
Margaret Houghton, 913-574-4186, mhoughton3@kumc.edu
UCSD Health La Jolla
La Jolla, California, 92037
Maryo Jajo, 858-657-7181, mjajo@ucsd.edu
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Diana De Los Santos, 323-783-3008, Diana.C.DeLosSantos@kp.org
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Brianna Andersen, 310-967-0845, brianna.andersen@cshs.org
University of Wisconsin - University Hospital
Madison, Wisconsin, 53792
Stephanie Wilbrand, 608-265-9248, wilbrand@neurosurgery.wisc.edu
Methodist University Hospital
Memphis, Tennessee, 38163
Samantha Davis, (901) 448-9855, brf767@uthsc.edu
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Kesha Lowe, MSN, RN, 612-863-3452, NeuroscienceResearch@allina.com
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55414
Anna Brauch, 763-843-9497, brauc019@umn.edu
University of South Alabama - University Hospital
Mobile, Alabama, 36688
J.W. Ruby Memorial Hospital
Morgantown, West Virginia, 26506
Jay Sherman, 304 598 4000 ext 146307, shermanj@wvumedicine.org
Intermountain Medical Center
Murray, Utah, 84107
Nic Unsworth, 801-507-8280, nic.unsworth@imail.org
Yale New Haven Hospital
New Haven, Connecticut, 06511
Michael Kampp, 203-737-2073, michael.kampp@yale.edu
NYP Weill Cornell Medical Center
New York, New York, 10021
Ava Liberman, 646-962-8284, all9188@med.cornell.edu
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
April Vaughan, 405-271-4658, april-vaughan@ou.edu
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Sandra Combs, BSN, RN, 215-707-3040, sandra.combs@tuhs.temple.edu
Casa Colina Hospital
Pomona, California, 91767
Jeanette Gumarang, RN, 909-596-7733 ext. 2283, jgumarang@casacolina.org
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Alexis Young, 503-216-1492, alexis.young@providence.org
Oregon Health & Science University Hospital
Portland, Oregon, 97239
Leonel Lugo, 503-494-7222, lugol@ohsu.edu
Regions Hospital
Saint Paul, Minnesota, 55101
Allison Kehren, 651-254-5342, Allison.J.Kehren@HealthPartners.com
University of Utah Healthcare
Salt Lake City, Utah, 84132
Kinga Aitken, 801-581-5523, kinga.aitken@hsc.utah.edu
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
Jody Richardson, 210-450-0533, richardsonj1@uthscsa.edu
Harborview Medical Center
Seattle, Washington, 98104
Hana Neutz, 206-685-8666, hneutz@uw.edu
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Jenny Babka, 314-747-8794, babkaj@wustl.edu
SSM Health St. Louis University Hospital
St Louis, Missouri, 63110
Rachel Overberg, 314-617-3293, Rachel.cadmus@slucare.ssmhealth.com
Stanford University
Stanford, California, 94305
Riddhi Shah, 650-850-1499, rss76@stanford.edu
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Erika Bayne, 336-716-4270, erika.bayne@advocatehealth.org
About this study
The goal of this clinical study is to learn if adding a medicine called cilostazol to usual treatment can help prevent another stroke, a heart attack, or death in patients who had a stroke caused by a blocked blood vessel, or a "mini-stroke" (also called a TIA), in the past 6 months.
To determine if cilostazol is safe and effective at lowering the chance of strokes, heart attacks and deaths, the study will compare cilostazol to a placebo, a pill that looks the same as cilostazol but has no medicine in it.
Read more
Participants will:
- Be assigned by chance to take either cilostazol or a placebo, along with their usual medicine.
- Not know which one they are taking, and neither will the study team, which keeps the results fair.
- Be followed for up to 5 years to see if they have a stroke, heart attack, or major bleeding.
- Conditions
- Stroke Recurrence, Myocardial Infarction, Vascular Death, Ischemic Stroke, TIA (Transient Ischemic Attack), Stroke (CVA) or Transient Ischemic Attack
- Being tested
- Cilostazol 100 mg Tablets, Placebo
- Medical subject headings
- Myocardial Infarction, Ischemic Stroke, Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol 100 mg TabletsDrug
The standard dosing regimen is an initial 2-week period during which participants take one tablet of cilostazol (100 mg) orally once daily followed by a maintenance phase in which they take one tablet twice daily. For participants who are on certain interacting drugs or who experience adverse reactions on the standard dosing regimen, the dose is reduced to half a tablet twice daily.
PlaceboDrug
The standard dosing regimen is an initial 2-week period during which participants take one placebo tablet, which matches cilostazol 100 mg tablets, orally once daily followed by a maintenance phase in which they take one tablet twice daily. For participants who are on certain interacting drugs or who experience adverse reactions on the standard dosing regimen, the dose is reduced to half a tablet twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Experimental | Participants take oral cilostazol until a study endpoint occurs, they reach maximum follow up duration (5 years), the participant withdraws, or the study ends. Receives: Drug: Cilostazol 100 mg Tablets |
| Placebo | Placebo comparator | Participants take oral placebo until a study endpoint occurs, they reach maximum follow up duration (5 years), the participant withdraws, or the study ends. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of any component of the composite of ischemic stroke, acute myocardial infarction, or ischemic vascular death (MACE).
Major Adverse Cardiovascular Events (MACE) is a composite outcome. MACE is any one of the following: ischemic stroke, acute myocardial infarction (heart attack), or ischemic vascular death (death caused by a lack of blood flow). In this study, the measure is the time from randomization to a particpant's first MACE.
Measured: Up to 5 years after randomization
Secondary outcomes (2)
Time to first occurrence of ischemic stroke
Ischemic stroke is a stroke caused by a blocked blood vessel in the brain. The measure is the time from randomization to the first ischemic stroke
Measured: Up to 5 years after randomization
Time to first occurrence of major hemorrhage
Major hemorrhage is defined as the composite of 'major intracranial hemorrhage' and 'major extracranial hemorrhage', based on the International Society on Thrombosis and Haemostasis (ISTH) criteria. The measure is the time from randomization to the first major hemorrhage.
Measured: Up to 5 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startOct 2026 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Stroke RecurrenceStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Yale University, University of Cincinnati, Medical University of South Carolina
- Responsible party
- Principal investigator, Maarten Lansberg, Stanford University
- Investigators
- Maarten Lansberg, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174414
- Sponsor's protocol ID
- 82476
- Other IDs
- 1UG3NS133209-01A1
- Acronym
- Clarity
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 29766750Spieler 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 14641505Engel-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 20957133Serena 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 25884666Nedeltchev 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 15654030Khanevski 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 30929256Skajaa 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 34845054Oza R, Rundell K, Garcellano M. Recurrent Ischemic Stroke: Strategies for Prevention. Am Fam Physician. 2017 Oct 1;96(7):436-440.
PubMed 29094912Benjamin 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