- Elevation in pulsatility indices (PIs), measured by transcranial Doppler (TCD), has been postulated to reflect downstream increased vascular resistance caused by small-vessel disease (SVD).
- Small arterial vessels are a significant determinant of vascular resistance and PIs are elevated when SVD is present in the intracranial circulation.
- Cilostazol, a phosphodiesterase III inhibitor, has other non-antiplatelet effects, such as vasodilation and neuroprotective effect. It has been shown to be effective in the secondary prevention of stroke especially in the SVD and it may be related to the other non-antiplatelet effects of cilostazol.
- In this study, we aim to investigate whether cilostazol affects the changes of PIs in patients with acute lacunar infarction using serial TCDs.
- Our hypothesis is that cilostazol has other non-antiplatelet effects such as vasodilation effect and may decrease the vascular resistance in patients with acute lacunar infarction. Hence, cilostazol will decrease the PIs in patients with acute lacunar infarction.
- Cilostazol is an agent inhibiting platelet aggregation.
- A matching placebo of cilostazol is an inactive substance that looks similar to the active cilostazol tablet.
- There will be two treatment groups; one will receive cilostazol 200mg (100mg twice per day), the second matching placebo of cilostazol.
- These study drugs will be administered on top of aspirin (100mg) systematically prescribed to such patients
- The changes of PI between the baseline and 14 and 90 days follow-up study.
- Two hundred sixty patients, presenting with first ever lacunar infarction within 7 days after the onset of symptoms will be recruited within two years.
- Patients will be followed up during the three months.
- Aspirin (acute stroke) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Cilostazol (Pletal®)Drug
Other Names: Claudiasil Intervention Desc: Aspirin (100mg) plus cilostazol (200mg) ARM 1: Kind: Experimental Label: Asprin (100mg) plus cilostazol (200mg) Description: Asprin (100mg) plus cilostazol (200mg)
- Aspirin Drug
Other Names: clopidogrel; combination aspirin-dipyridamole Intervention Desc: Asprin (100mg) plus placebo ARM 1: Kind: Experimental Label: Asprin (100mg) plus placebo Description: Asprin (100mg) plus placebo
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
Initial assessment of all patients will include vital signs, risk factors, TCD, and laboratory data, with TCD and laboratory data repeated at 14 and 90 days. Participants are randomized to receive either cilostazole or placebo (100mg tablets twice daily, orally). Aspirin (100mg once daily) is given to all the participants.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Changes of pulsatility indices (PIs).|
|Secondary||Sroke recurrence at 90 days.|
|Primary||The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study||14 days and 90 days from the baseline TCD study||No|
|Secondary||Number of Patients With First Recurrent Stroke of Any Type||90 days||No|