The Effect of Cilostazol Compared to Aspirin on Endothelial Function in Acute Cerebral Ischemia Patients
PASS
1 other identifier
interventional
80
1 country
1
Brief Summary
Patients presenting with acute cerebral ischemic events are randomly assigned into aspirin (n=40) or cilostazol (n=40) group in a double-blinded manner. FMD is measured as a primary outcome at baseline (T0) and 90 days (T1). Serious and non-serious adverse events were described.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2014
CompletedFirst Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 17, 2017
CompletedApril 17, 2017
April 1, 2017
2.7 years
April 12, 2017
April 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
flow mediated dilation
flow mediated dilation of the brachial artery in response to hyperemia
3 month change
Study Arms (2)
cilostazol group
EXPERIMENTALaspirin placebo daily and 100 mg cilostazol twice daily
aspirin group
ACTIVE COMPARATOR100 mg aspirin daily and cilostazol placebo twice daily
Interventions
Eligibility Criteria
You may qualify if:
- acute ischemic stroke confirmed by diffusion weighted imaging
- transient ischemic attack (TIA) within 7 days
You may not qualify if:
- there is intracranial hemorrhage on imaging study
- patients is previously taking antiplatelets, vitamin K antagonists, factor Xa antagonists, or chronic treatment with systemic steroidal and non-steroidal anti-inflammatory drugs
- patients who received fibrinolytics within the previous 48 hours
- cognitive impairment interfering with the possibility of obtaining informed consent
- pregnancy
- participation in another pharmacological study
- peptic ulcer disease or hematological abnormality
- initial modified Barthel index \<30 points
- liver function tests exceeding a 2-fold upper range value.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ajou University Medical Center
Suwon, Gyunggido, South Korea
Related Publications (1)
Lee SJ, Lee JS, Choi MH, Lee SE, Shin DH, Hong JM. Cilostazol improves endothelial function in acute cerebral ischemia patients: a double-blind placebo controlled trial with flow-mediated dilation technique. BMC Neurol. 2017 Aug 29;17(1):169. doi: 10.1186/s12883-017-0950-y.
PMID: 28851320DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Man Hong
82 31 219 5174
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate proffessor
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 17, 2017
Study Start
March 1, 2012
Primary Completion
October 31, 2014
Study Completion
October 31, 2014
Last Updated
April 17, 2017
Record last verified: 2017-04