Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler
Information source: Inje University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Infarction
Intervention: Aspirin (Drug); cilostazol (Drug)
Phase: Phase 4
Status: Recruiting
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
Overall contact:
Jae Hyeon Park, MD, PhD, Phone: 82-2-950-1090, Email: jhparkmd@paik.ac.kr
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The changes of pulsatility index (PI)
Secondary outcome: Stroke events
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
Jae Hyeon Park, MD, PhD, Phone: 82-2-950-1090, Email: jhparkmd@paik.ac.kr
National medical center, Seoul 100-799, Korea, Republic of; Recruiting
Jong Yun Lee, MD, Phone: 80-2-2260-7114, Email: jjongyl@gmail.com
Jong Yun Lee, MD, Principal Investigator
Im-Seok Koh, MD, Sub-Investigator
National Health Insurance Corporation Ilsan Hospital, Ilsan 411-719, Korea, Republic of; Recruiting
Gyu Sik Kim, MD, Phone: 82-031-900-0570, Email: jiyongkim2002@yahoo.co.kr
Jun Hong Lee, MD, PhD, Principal Investigator
Gyu Sik Kim, MD, Sub-Investigator
Bundang CHA Hospital, Seongnam 463-712, Korea, Republic of; Recruiting
Ok Joon Kim, MD, PhD, Phone: 82-031-780-5100, Email: okjun77@cha.ac.kr
Ok Joon Kim, MD, PhD, Principal Investigator
Ajou University Hospital, Suwon 443-721, Korea, Republic of; Recruiting
Seok Woo Yong, MD, Phone: 82-031-219-5656, Email: mistman@naver.com
Seok Woo Yong, MD, Principal Investigator
Hyo Suk Nam, MD, Sub-Investigator
Sanbon Medical Center, Gunpo 435-040, Korea, Republic of; Recruiting
Sung Ik Lee, MD, Phone: 82-31-390-2423, Email: esungik@paran.com
Seung-Han Suk, MD, PhD, Principal Investigator
Sung Ik Lee, MD, Sub-Investigator
Yongdong Severance Hospital, Seoul 135-720, Korea, Republic of; Recruiting
Won-Joo Kim, MD, PhD, Phone: 82-2-2019-2370, Email: kzoo@yuhs.ac
Kyung-Yul Lee, MD, PhD, Principal Investigator
Young-Chul Choi, MD, PhD, Sub-Investigator
Won-Joo Kim, MD, PhD, Sub-Investigator
Sanggye Paik Hospital, Seoul 139-707, Korea, Republic of; Recruiting
Sang Won Han, MD, Phone: 82-2-950-1090, Email: swhan@paik.ac.kr
Jae Hyeon Park, MD, PhD, Principal Investigator
Sang Won Han, MD, Sub-Investigator
Wonju Christian Hospital, Wonju 220-701, Korea, Republic of; Recruiting
Seo Hyun Kim, MD, PhD, Phone: 82-033-741-1250, Email: s-hkim@yonsei.ac.kr
Sung-Soo Lee, MD, PhD, Principal Investigator
Seo Hyun Kim, Md, PhD, Sub-Investigator
Additional Information
Starting date: November 2006
Ending date: October 2008
Last updated: August 25, 2008
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