Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler - Full Text View

Sponsor:	Inje University
Collaborator:	Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:	Inje University
ClinicalTrials.gov Identifier:	NCT00741286

Purpose

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.

Condition	Intervention	Phase
Cerebral Infarction	Drug: Aspirin Drug: cilostazol	Phase IV

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
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

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Cilostazol

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Number of Patients With First Recurrent Stroke of Any Type [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment:	203
Study Start Date:	November 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Asprin (100mg) plus placebo Asprin (100mg) plus placebo	Drug: Aspirin Asprin (100mg) plus placebo Other Name: Aspirin
Active Comparator: Asprin (100mg) plus cilostazol (200mg) Asprin (100mg) plus cilostazol (200mg)	Drug: cilostazol Aspirin (100mg) plus cilostazol (200mg) Other Name: Pletaal

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

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741286

Locations

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

Sponsors and Collaborators

Inje University

Korea Otsuka Pharmaceutical Co.,Ltd.

Investigators

Principal Investigator:

Jae Hyeon Park, MD, PhD

Sanggye Paik Hospital, Inje University College of Medicine

More Information

No publications provided

Responsible Party:	Jae Hyeon Park, MD, PhD, Sanggye Paik Hospital, Inje University College of Medicine
ClinicalTrials.gov Identifier:	NCT00741286 History of Changes
Other Study ID Numbers:	ECLIPse
Study First Received:	August 25, 2008
Results First Received:	August 3, 2010
Last Updated:	August 4, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Inje University:

Cerebral infarction
Cilostazol
Aspirin
Transcranial Doppler
Pulsatile Index

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Aspirin

Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012