Cilostazol For Prevention Of Recurrent Stroke Trial

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 04/06/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Michelle Lin, M.D., M.P.H.

Contact us for the latest status

More information

Publications

  • To examine risks of stroke recurrence and mortality after first and recurrent stroke. Read More on PubMed
  • Recurrent ischemic stroke (IS) or TIA is frequent with a considerable variation in incidence and mortality across populations. Current data on stroke recurrence and mortality are useful to examine trends, risk factors, and treatment effects. In this study, we calculated the incidence of recurrent IS or TIA in a hospital-based stroke population in Western Norway, investigated recurrence factors, and estimated the effect of recurrence on all-cause mortality. Read More on PubMed
  • Combination antiplatelet therapy with clopidogrel and aspirin may reduce the rate of recurrent stroke during the first 3 months after a minor ischemic stroke or transient ischemic attack (TIA). A trial of combination antiplatelet therapy in a Chinese population has shown a reduction in the risk of recurrent stroke. We tested this combination in an international population. Read More on PubMed
  • Recurrent strokes make up almost 25% of the nearly 800,000 strokes that occur annually in the United States. Risk factors for ischemic stroke include hypertension, diabetes mellitus, hyperlipidemia, sleep apnea, and obesity. Lifestyle modifications, including tobacco cessation, decreased alcohol use, and increased physical activity, are also important in the management of patients with a history of stroke or transient ischemic attack. Antiplatelet therapy is recommended to reduce the risk of recurrent ischemic stroke. The selection of antiplatelet therapy should be based on timing, safety, effectiveness, cost, patient characteristics, and patient preference. Aspirin is recommended as initial treatment to prevent recurrent ischemic stroke. Clopidogrel is recommended as an alternative monotherapy and in patients allergic to aspirin. The combination of clopidogrel and aspirin is not recommended for long-term use (more than two to three years) because of increased bleeding risk. Aspirin/dipyridamole is at least as effective as aspirin alone, but it is not as well tolerated. Warfarin should not be used for prevention of recurrent ischemic stroke. Read More on PubMed
  • About 20% of patients with a first ischaemic stroke will experience a new vascular event within the first year. The atherosclerotic burden, an indicator of the extension of atherosclerosis in a patient, has been associated with the risk of new cardiovascular events in the general population. However, no predictive models reliably identify groups at a high risk of recurrence. The ARTICO study prospectively analysed the predictive value for the risk of recurrence of specific atherosclerotic markers. Read More on PubMed
  • To evaluate the clinical outcomes and incremental health care costs of ischemic stroke in a US managed care population. Read More on PubMed
  • There is limited information about predictors of outcome and recurrence of ischaemic stroke affecting young adults. Read More on PubMed
  • When assessing the cost-effectiveness of the secondary prevention of stroke, it is not well known whether the cost of a recurrent brain infarction (BI) is different from a first-ever BI. In a cohort of 435 consecutive prevalent cases of BI (including both recurrent and first-ever BI) we collected medical and socio-economic variables. Handicap was measured with the Rankin scale. Only the direct medical costs were considered over an 18-month period from a societal perspective. We compared first-ever to recurrent BI. Of the 435 patients 20.5% had a recurrent BI. The length of the initial hospitalization and the distribution of the patients into the three classes of handicap (Rankin 0-2, 3, and 4-5) were similar in the first-ever and recurrent BI groups. The average total cost of a first-ever BI was euro 19 725 (95% CI, 17 950-21 501) and euro 18 560 (95% CI, 15 798-21 322) for a recurrent BI (P = 0.48). There were no differences between the two groups when the costs were compared by handicap levels (P = 0.17) or when the costs were compared for each type of expenditure (initial hospitalization, rehabilitation, ambulatory services) except for long-term care, because of the small number of cases. This study suggests that the costs of recurrent BI are roughly similar to the costs of first-ever BI, which may be helpful when studying the cost-effectiveness of secondary stroke prevention trials. Read More on PubMed

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