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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00741286
• Date of registration: 25/08/2008
• Primary sponsor: Inje University
• Public title: Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler ECLIPse
• Scientific 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
• Date of first enrolment: November 2006
• Target sample size: 203
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00741286
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jae Hyeon Park, MD, PhD
• Affiliation: Sanggye Paik Hospital, Inje University College of Medicine

Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cerebral Infarction

Intervention(s)

Drug: Aspirin

Drug: cilostazol

Primary Outcome(s)

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 [Time Frame: 14 days and 90 days from the baseline TCD study]

Secondary Outcome(s)

Number of Patients With First Recurrent Stroke of Any Type [Time Frame: 90 days]

Secondary ID(s)

ECLIPse

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Korea Otsuka Pharmaceutical Co.,Ltd.