Cilostazol for Prevention of Recurrent Stroke Trial (Clarity)

Stanford University

Status and phase: Begins enrollment in 5 months; Phase 3

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

Treatments: Drug: Placebo; Drug: Cilostazol 100 mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07174414

82476

1UG3NS133209-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,000 participants in 2 patient groups, including a placebo group

Cilostazol 100mg

Experimental group

Description:

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

Treatment:

Drug: Cilostazol 100 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo