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

August 4, 2011 updated by: Inje University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Gunpo, Korea, Republic of, 435-040
        • Sanbon Medical Center
      • Ilsan, Korea, Republic of, 411-719
        • National Health Insurance Corporation Ilsan Hospital
      • Seongnam, Korea, Republic of, 463-712
        • Bundang CHA Hospital
      • Seoul, Korea, Republic of, 100-799
        • National Medical Center
      • Seoul, Korea, Republic of, 135-720
        • Yongdong Severance Hospital
      • Seoul, Korea, Republic of, 139-707
        • Sanggye Paik hospital
      • Suwon, Korea, Republic of, 443-721
        • Ajou University Hospital
      • Wonju, Korea, Republic of, 220-701
        • Wonju Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Asprin (100mg) plus placebo
Drug: Aspirin
Asprin (100mg) plus placebo
ACTIVE_COMPARATOR: Asprin (100mg) plus cilostazol (200mg)
Drug: cilostazol
Aspirin (100mg) plus cilostazol (200mg)
Other Names:
  • Pletaal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling's PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study.
14 days and 90 days from the baseline TCD study

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients With First Recurrent Stroke of Any Type
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (ESTIMATE)

August 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECLIPSE (Rakuten Medical)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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