Nervous System Diseases
Conditions
Interventions
Cilostazol
Placebo
Sponsors
Northern Californian Institute of Research and Education
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Above the age of 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 3. Ischemic stroke or TIA should be confirmed by either with a cranial CT or MRI within 10 days of symptom onset, 4. Aspirin or clopidogrel monotherapy, Participants with major TIA are eligible after completing 21 days of dual antiplatelets after which they are being switched to either aspirin or clopidogrel monotherapy 5. Subjects with stroke may present with any 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; 6. Legally competent to sign informed consent; 7. 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.
Exclusion criteria
Exclusion criteria: 1. Unable to provide a valid informed consent; for participants with inability to comprehend the study details where there is no proxy nor a legally authorized representative (LAR) 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 of any severity 3. Hemorrhagic stroke survivor within the last 2 years; 4. Recurrent ischemic stroke 5. Use of an anticoagulant medication or indication for use of an anticoagulant (e.g. atrial fibrillation) 6. On dual antiplatelet therapy (patients are eligible after completion of a course of dual antiplatelet therapy; 7. Modified Rankin Scale 5; 8. Thrombocytopenia (platelet count <1000,000); 9. Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C); 10. Congestive heart failure, defined as NYHA Class III or above (marked limitation of physical activity); 11. Nursing/pregnant mothers; 12. Do not agree to the filing, forwarding and use of his/her pseudonymized data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of Stroke (ischemic and hemorrhagic), myocardial infarction, or vascular death (MACE). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety measures – major haemorrhage: fatal haemorrhage, hemorrhagic stroke, hemorrhage requiring transfusion, hemorrhage causing vision loss;Recurrent ischemic stroke;Hemorrhagic stroke;Cardiovascular deaths;All cause deaths ;Quality of life;Global cognitive performance;Side effects, adverse events;Implementation outcomes- adoption, implementation cost | — |
Countries
Ghana
Contacts
Public ContactNathaniel Mensah
Komfo Anokye. Teaching Hospital
Outcome results
None listed