Phase 4
N=203
Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler
Cerebral Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00741286 ↗Enrolled (actual)
203
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: 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 — 0.07; 0.08; 0.09; 0.14 ratio — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aspirin (Drug); cilostazol (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Inje University
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0.07; 0.08; 0.09; 0.14; 0.08; 0.1 | <0.05 sig |
| SECONDARY Number of Patients With First Recurrent Stroke of Any Type |
1; 1 | <0.05 sig |
Summary
RATIONALE:
* 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.
OBJECTIVES:
* 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.
Eligibility Criteria
Inclusion Criteria
- Patients with first ever lacunar infarction within 7 days after the onset of symptoms
- Age: more than 45 years of age
Exclusion Criteria
- Patients with any contraindications to the treatment with antiplatelet therapy
- Patients with potential cardiac embolic source; prosthetic valve, atrial fibrillation, atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse, mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis, congestive heart failure, recent myocardial infarction (within 4 weeks)
- Bleeding diathesis
- Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
- Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
- Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting arterial dissection, moyamoya disease, Takayasu's arteritis, radiation associated angiopathy, and other vasculitis.
- Pregnant or lactating patients
- Patients with hyperthyroidism or COPD
- Patients with current anticoagulation or antiplatelet therapy
- Patients with poor temporal window in transcranial Doppler
Data sourced from ClinicalTrials.gov (NCT00741286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.