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| 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 |
| Condition: |
Cerebral Infarction |
| Interventions: |
Drug: Aspirin Drug: cilostazol |
Participant Flow
| 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. |
| 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. |
| 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 |
| 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
| 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 |
| Asprin Plus Placebo | Asprin Plus Cilostazol | Total | |
|---|---|---|---|
|
Number of Participants
[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
| 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 ] |
More Information
| 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. |
| 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 |
|---|
| No text entered. |
| 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 |
