Clinical trial NCT00741286: Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler
Official title: Study for the Multi-Center Placebo-Controlled Double-Blind Clinical Trial for the Evaluation of the Effect of Cilostazol on Pulsatility Index of Transcranial Doppler in the Acute Lacunar Infarction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Infarction
Keywords: Cerebral infarction
Cilostazol
Aspirin
Transcranial Doppler
Pulsatile Index
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2008-08-26
Enrollment: 203
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: TREATMENTS:

* Cilostazol is an agent inhibiting platelet aggregation.
* A matching placebo of cilostazol is an inactive substance that looks similar to the active cilostazol tablet.

TREATMENT PLAN:

* 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

PRIMARY ENDPOINT:

* The changes of PI between the baseline and 14 and 90 days follow-up study.

STUDY EXECUTION:

* 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.

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

Primary outcomes:
measure: 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
timeFrame: 14 days and 90 days from the baseline TCD study
Secondary outcomes:
measure: Number of Patients With First Recurrent Stroke of Any Type
timeFrame: 90 days
Other outcomes:
Locations:
city: Gunpo
country: Korea, Republic of
facility: Sanbon Medical Center
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seoul
country: Korea, Republic of
facility: National medical center
city: Seoul
country: Korea, Republic of
facility: Yongdong Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Sanggye Paik Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
affiliation: Sanggye Paik Hospital, Inje University College of Medicine
name: Jae Hyeon Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han SW, Lee SS, Kim SH, Lee JH, Kim GS, Kim OJ, Koh IS, Lee JY, Suk SH, Lee SI, Nam HS, Kim WJ, Yong SW, Lee KY, Park JH. Effect of cilostazol in acute lacunar infarction based on pulsatility index of transcranial Doppler (ECLIPse): a multicenter, randomized, double-blind, placebo-controlled trial. Eur Neurol. 2013;69(1):33-40. doi: 10.1159/000338247. Epub 2012 Nov 1.