The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorAsan Medical Center
About this trial
Currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of CHANCE and POINT trial. However, still a considerable portion of patients showed early stroke recurrence, especially in those with stroke due to large artery atherosclerosis. Cilostazol may have benefit in reducing early stroke recurrence of neurologic deterioriation. The post-hoc analysis of CSPS.com showed that use of cilostazol after 15 days of stroke was effective for preventing subsequent stroke. The effect of adding cilostazol was more effective in those with large artery atherosclerosis and those receiving clopidogrel than aspirin.
Eligibility criteria
Qualifiers
Age of 20 years or older
Acute ischemic stroke due to large artery atherosclerosis (both including Intra and extracranial atherosclerosis) which may be defined by a ischemic lesion confirmed at diffusion-weighted image and a corresponding significant stenosis (more than 50% of diameter reduction) proximal to the ischemic lesion confirmed by MR angiography or CT angiography.
Informed consent obtained within 72h from stroke onset
Acquisition of written informed consent prior to study entry
Disqualifiers
Large infarction unable to start antiplatelet treatment
Combined with acute intracranial haemorrhage
With initial haemorrhagic transformation
Previous mRS higher than 2
Trial design
Treatments tested in this trial
- Aspirin
- Clopidogrel
- Cilostazol
- Placebo
Treatment groups
2,340 Participants
are divided into 2 treatment groupsSponsors and collaborators
Asan Medical Center
Lead sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov