Trial Outcomes & Findings for Effect of Cilostazol in the Acute Lacunar Infarction Based on Pulsatility Index of Transcranial Doppler (NCT NCT00741286)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

203 participants

Primary outcome timeframe

14 days and 90 days from the baseline TCD study

Results posted on

2011-09-05

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	103	100
Overall Study COMPLETED	83	81
Overall Study NOT COMPLETED	20	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	15	10
Overall Study Adverse Event	1	6
Overall Study Protocol Violation	3	2
Overall Study Primary Outcome	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asprin Plus Placebo n=103 Participants Placebo twice a day on top of aspirin 100mg a day	Asprin Plus Cilostazol n=100 Participants Cilostazol (100mg) twice a day on top of aspirin 100mg a day	Total n=203 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	45 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Age Continuous	65.48 years STANDARD_DEVIATION 9.92 • n=5 Participants	64.63 years STANDARD_DEVIATION 9.07 • n=7 Participants	65.06 years STANDARD_DEVIATION 9.50 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	74 Participants n=7 Participants	152 Participants n=5 Participants
Region of Enrollment Korea, Republic of	103 participants n=5 Participants	100 participants n=7 Participants	203 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days and 90 days from the baseline TCD study

Population: Of the 203 patients included in the intention-to-treat analysis, 164 were included in the per-protocol analysis of the primary outcome.

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.

Outcome measures

Outcome measures
Measure	Asprin Plus Placebo n=83 Participants Placebo twice a day on top of aspirin 100mg a day	Asprin Plus Cilostazol n=81 Participants Cilostazol (100mg) twice a day on top of aspirin 100mg a day
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 Changes of PI in Right MCA (14 days)	0.07 ratio Standard Deviation 0.13	0.08 ratio Standard Deviation 0.13
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 Changes of PI in Right MCA (90 days)	0.09 ratio Standard Deviation 0.13	0.14 ratio Standard Deviation 0.13
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 Changes of PI in Left MCA (14 days)	0.08 ratio Standard Deviation 0.13	0.1 ratio Standard Deviation 0.14
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 Changes of PI in Left MCA (90 days)	0.07 ratio Standard Deviation 0.13	0.13 ratio Standard Deviation 0.13
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 Changes of PI in BA (14 days)	0.09 ratio Standard Deviation 0.14	0.09 ratio Standard Deviation 0.14
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 Changes of PI in BA (90 days)	0.1 ratio Standard Deviation 0.18	0.18 ratio Standard Deviation 0.16

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	Asprin Plus Placebo n=83 Participants Placebo twice a day on top of aspirin 100mg a day	Asprin Plus Cilostazol n=81 Participants Cilostazol (100mg) twice a day on top of aspirin 100mg a day
Number of Patients With First Recurrent Stroke of Any Type	1 participants	1 participants

Adverse Events

Asprin Plus Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asprin Plus Cilostazol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sang Won Han

Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine

Phone: 82-2-950-8864

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place