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The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis

ConditionsCerebral InfarctionStenosis Artery
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

    Aspirin 100mg qd (21days) * In case of stenting, aspirin will be added to cilostazol and clopidogrel until 90 days after stenting. * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)

  • Clopidogrel

    Drug

    Clopidogrel 75mg qd (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)

  • Cilostazol

    Drug

    Cilostazol SR 100mg x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)

  • Placebo

    Drug

    Placebo x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd)

Treatment groups

2,340 Participants
are divided into 2 treatment groups
Group A: CA groupExperimental treatment 3 interventions
Group B: PA groupPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Proportion of occurrence of composite endpoint

\*Composite endpoint: Neurologic deterioration† during admission (within 14 days) or recurrence of ischemic stroke‡ within 180 days after stroke †Neurologic deterioration: Increment of 2 or more in total NIHSS(National Institutes of Health Stroke Scale) score or one or more in the motor NIHSS score. ‡Recurrence of ischemic stroke: A newly developed neurological deficit corresponding to a new ischemic lesion confirmed by neuro-imaging.

Time frame
during admission (within 14 days) and within 180 days after stroke

Secondary outcomes

1

Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2)

Time frame
at 180 days
2

mRS score collected at 180 days

Time frame
at 180 days
3

Proportion of participants with Neurologic Deterioration(ND) during admission

Time frame
during admission(within 14days)
4

Proportion of participants with good functional outcome (mRS 0-2)

Time frame
at 90 days

Other outcomes

1

Preplanned subgroup analysis

For the primary endpoint, analyses will be performed in the following subgroups: Proportion of occurrence of composite endpoint\* in patients with 1. Intracranial atherosclerosis 2. Extracranial atherosclerosis 3. Stent insertion 4. CYP2C19 poor metabolizers * Composite endpoint: Neurologic deterioration during admission (within 14 days) or recurrence of ischemic stroke within 180 days after stroke

Time frame
during admission (within 14 days), within 180days
2

Time to recurrence of ischemic stroke

Time frame
within 180days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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