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 Control: Placebo Control 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 pulsatility index (PI) [ Time Frame: Two weeks and three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stroke events [ Time Frame: Three months ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	November 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Asprin (100mg) plus placebo	Drug: Aspirin Asprin (100mg) plus placebo
2: Active Comparator Asprin (100mg) plus cilostazol (200mg)	Drug: cilostazol Aspirin (100mg) plus cilostazol (200mg)

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

Contacts

Contact: Jae Hyeon Park, MD, PhD	82-2-950-1090	jhparkmd@paik.ac.kr
Contact: Sang Won Han, MD	82-2-950-1990 ext 801	swhan@paik.ac.kr

Locations

Korea, Republic of
Sanbon Medical Center	Recruiting
Gunpo, Korea, Republic of, 435-040
Contact: Sung Ik Lee, MD 82-31-390-2423 esungik@paran.com
Principal Investigator: Seung-Han Suk, MD, PhD
Sub-Investigator: Sung Ik Lee, MD
National Health Insurance Corporation Ilsan Hospital	Recruiting
Ilsan, Korea, Republic of, 411-719
Contact: Gyu Sik Kim, MD 82-031-900-0570 jiyongkim2002@yahoo.co.kr
Principal Investigator: Jun Hong Lee, MD, PhD
Sub-Investigator: Gyu Sik Kim, MD
Bundang CHA Hospital	Recruiting
Seongnam, Korea, Republic of, 463-712
Contact: Ok Joon Kim, MD, PhD 82-031-780-5100 okjun77@cha.ac.kr
Principal Investigator: Ok Joon Kim, MD, PhD
Yongdong Severance Hospital	Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Won-Joo Kim, MD, PhD 82-2-2019-2370 kzoo@yuhs.ac
Principal Investigator: Kyung-Yul Lee, MD, PhD
Sub-Investigator: Young-Chul Choi, MD, PhD
Sub-Investigator: Won-Joo Kim, MD, PhD
Wonju Christian Hospital	Recruiting
Wonju, Korea, Republic of, 220-701
Contact: Seo Hyun Kim, MD, PhD 82-033-741-1250 s-hkim@yonsei.ac.kr
Principal Investigator: Sung-Soo Lee, MD, PhD
Sub-Investigator: Seo Hyun Kim, Md, PhD
Sanggye Paik Hospital	Recruiting
Seoul, Korea, Republic of, 139-707
Contact: Sang Won Han, MD 82-2-950-1090 swhan@paik.ac.kr
Principal Investigator: Jae Hyeon Park, MD, PhD
Sub-Investigator: Sang Won Han, MD
Ajou University Hospital	Recruiting
Suwon, Korea, Republic of, 443-721
Contact: Seok Woo Yong, MD 82-031-219-5656 mistman@naver.com
Principal Investigator: Seok Woo Yong, MD
Sub-Investigator: Hyo Suk Nam, MD
National medical center	Recruiting
Seoul, Korea, Republic of, 100-799
Contact: Jong Yun Lee, MD 80-2-2260-7114 jjongyl@gmail.com
Principal Investigator: Jong Yun Lee, MD
Sub-Investigator: Im-Seok Koh, MD

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

Keywords provided by Inje University:

Cerebral infarction
Cilostazol
Aspirin
Transcranial Doppler
Pulsatile Index

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Neuroprotective Agents
Cerebrovascular Disorders
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Aspirin

Sensory System Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Cilostazol
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Anti-Asthmatic Agents
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents

ClinicalTrials.gov processed this record on March 18, 2010