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Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler

Information source: Inje University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Infarction

Intervention: Aspirin (Drug); cilostazol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Inje University

Official(s) and/or principal investigator(s):
Jae Hyeon Park, MD, PhD, Principal Investigator, Affiliation: Sanggye Paik Hospital, Inje University College of Medicine

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: Number of Patients With First Recurrent Stroke of Any Type

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

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Sanbon Medical Center, Gunpo 435-040, Korea, Republic of

National Health Insurance Corporation Ilsan Hospital, Ilsan 411-719, Korea, Republic of

Bundang CHA Hospital, Seongnam 463-712, Korea, Republic of

National medical center, Seoul 100-799, Korea, Republic of

Sanggye Paik Hospital, Seoul 139-707, Korea, Republic of

Yongdong Severance Hospital, Seoul 135-720, Korea, Republic of

Ajou University Hospital, Suwon 443-721, Korea, Republic of

Wonju Christian Hospital, Wonju 220-701, Korea, Republic of

Additional Information

Starting date: November 2006
Last updated: August 4, 2011

Page last updated: August 23, 2015

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