Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT06919835
Eligibility Criteria:
Inclusion Criteria:
1. Above the age of 30 years; male or female (sex is a biological variable of interest)
2. Ischemic stroke or high-risk TIA (ABCD2 score \>= 6) diagnosis no greater than six months before enrollment. Ischemic strokes including lacunar, large vessel atherosclerotic, embolic stroke of undetermined source subtypes are eligible (Ischemic stroke or TIA should be confirmed by either with a cranial CT or MRI within 10 days of symptom onset)
3. Aspirin or clopidogrel monotherapy
4. Subjects with stroke may present with two or more of the following additional conditions: age ≥65 years, documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \>140/90mmHg or previous treatment with anti-hypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
5. Legally competent to sign informed consent or have a LARs who is able to provide consent for them
6. In the opinion of the treating physician, patient is medically stable, capable of participating in a randomized trial, and willing and able to attend follow-up.
7. Able to do labs at all study intervals (7 visits total)
Exclusion Criteria:
1. Unable to provide a valid informed consent
2. Contraindications to cilostazol (namely (i) hypersensitivity, (ii) active pathologic bleeding, e.g. bleeding peptic ulcer, intracranial bleeding due to reversible platelet aggregation, (iii) congestive cardiac failure.)
3. Hemorrhagic stroke survivor within the last 2 years
4. Use of an anticoagulant medication or indication for use of an anticoagulant (e.g. atrial fibrillation)
5. On dual antiplatelet therapy (patients are eligible after completion of a course of dual antiplatelet therapy)
6. Modified Rankin Scale 5
7. Thrombocytopenia (platelet count \<1000,000)
8. Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C)
9. Congestive heart failure, defined as NYHA Class III or above (marked limitation of physical activity)
10. Nursing/pregnant mothers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT06919835
Study Brief:
Protocol Section:
NCT06919835