Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler (ECLIPse)
|ClinicalTrials.gov Identifier: NCT00741286|
Recruitment Status : Completed
First Posted : August 26, 2008
Results First Posted : September 5, 2011
Last Update Posted : September 5, 2011
- 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.
- 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 or disease||Intervention/treatment||Phase|
|Cerebral Infarction||Drug: Aspirin Drug: cilostazol||Phase 4|
- Cilostazol is an agent inhibiting platelet aggregation.
- A matching placebo of cilostazol is an inactive substance that looks similar to the active cilostazol tablet.
- 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
- The changes of PI between the baseline and 14 and 90 days follow-up study.
- 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 (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||November 2006|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
Placebo Comparator: Asprin (100mg) plus placebo
Asprin (100mg) plus placebo
Asprin (100mg) plus placebo
Active Comparator: Asprin (100mg) plus cilostazol (200mg)
Asprin (100mg) plus cilostazol (200mg)
Aspirin (100mg) plus cilostazol (200mg)
Other Name: Pletaal
- 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.
- Number of Patients With First Recurrent Stroke of Any Type [ Time Frame: 90 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741286
|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|
|National medical center|
|Seoul, Korea, Republic of, 100-799|
|Yongdong Severance Hospital|
|Seoul, Korea, Republic of, 135-720|
|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|
|Principal Investigator:||Jae Hyeon Park, MD, PhD||Sanggye Paik Hospital, Inje University College of Medicine|