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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741286
First Posted: August 26, 2008
Last Update Posted: September 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Inje University
Results First Submitted: August 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cerebral Infarction
Interventions: Drug: Aspirin
Drug: cilostazol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
ECLIPse was designed as a multicenter, randomized, double-blind, placebo-controlled trial. Between November 2006 and October 2008, 203 patients were consecutively enrolled from eight tertiary-care hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 513 patients who had experienced their first classic lacunar syndromes were screened for study enrollment, of which 101 (19.7% of the screened population) refused to participate in the study. Seventy-four patients (14.4%) were not eligible for the trial, and 135 (26.3%) were excluded by the exclusion criteria.

Reporting Groups
  Description
Asprin Plus Placebo Placebo twice a day on top of aspirin 100mg a day
Asprin Plus Cilostazol Cilostazol (100mg) twice a day on top of aspirin 100mg a day

Participant Flow:   Overall Study
    Asprin Plus Placebo   Asprin Plus Cilostazol
STARTED   103   100 
COMPLETED   83   81 
NOT COMPLETED   20   19 
Lost to Follow-up                15                10 
Adverse Event                1                6 
Protocol Violation                3                2 
Primary Outcome                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Asprin Plus Placebo Placebo twice a day on top of aspirin 100mg a day
Asprin Plus Cilostazol Cilostazol (100mg) twice a day on top of aspirin 100mg a day
Total Total of all reporting groups

Baseline Measures
   Asprin Plus Placebo   Asprin Plus Cilostazol   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   100   203 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   47   45   92 
>=65 years   56   55   111 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.48  (9.92)   64.63  (9.07)   65.06  (9.50) 
Gender 
[Units: Participants]
     
Female   25   26   51 
Male   78   74   152 
Region of Enrollment 
[Units: Participants]
     
Korea, Republic of   103   100   203 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Number of Patients With First Recurrent Stroke of Any Type   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sang Won Han
Organization: Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine
phone: 82-2-950-8864
e-mail: swhan@paik.ac.kr


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Submitted: August 25, 2008
First Posted: August 26, 2008
Results First Submitted: August 3, 2010
Results First Posted: September 5, 2011
Last Update Posted: September 5, 2011