Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-79
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

Cerebral small vessel disease (cSVD) is a common accompaniment of aging. Recent small subcortical (or lacunar) infarcts (i.e. symptomatic cSVD) and white matter hyperintensities are typical cSVD lesions on neuroimaging. cSVD causes about a quarter of ischaemic strokes and related with cognitive dysfunction. However, few studies are available so far to especially explore the treatment of cSVD. Endothelial dysfunction plays an important part in cSVD. Cilostazol and isosorbide mononitrate have endothelial protective function. We designed this prospective cohort study in China, aiming to evaluate the effect of different antiplatelet agents (e.g. Cilostazol) on cSVD and retina in patients with cSVD (recent small subcortical infarcts or WMH, respectively).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 30 years and ≤ 79 years.

A recent small subcortical infarct that occurred within 3 weeks prior to randomization; or patient with whiter matter hyperintensities with a 2-3 grading on Fazekas scale.

Absence of signs or symptoms of cortical dysfunction, such as aphasia, apraxia, agnosia, agraphia, homonymous visual field defect.

Modified Rankin score of ≤ 4.

Disqualifiers

Intracranial aneurysms that need surgical treatment. Other significant active neurological illness e.g seizures, multiple sclerosis, intracranial tumor (except meningioma) or any intracranial vascular malformation.

Active cardiac disease (atrial fibrillation, myocardial infarct in last six months, active angina, symptomatic cardiac failure).

History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural).

Known allergy or contraindication to aspirin, clopidogrel, cilostazol, isosorbide mononitrate or statin.

Trial population

Patients with a recent small subcortical infarct that occurred within 3 weeks prior to randomization, or patient with whiter matter hyperintensities with a 2-3 grading on Fazekas scale will be recruited.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clopidogrel

    Drug

    Patients will take Clopidogrel

  • Aspirin

    Drug

    Patients will take Rivaroxaban

  • Cilostazol + Isosorbide Mononitrate

    Drug

    Patients will take Cilostazol plus Isosorbide Mononitrate

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Patients with recent small subcortical infarct3 interventions
Group B: Patients with Whiter matter changes3 interventions

Trial outcomes

Primary outcomes

1

the impact of different antiplatelet agents on retinal vasculature.

retinal vasculature will be assessed by optical coherence tomography and optical coherence tomography angiography.

Time frame
6 months follow up

Secondary outcomes

1

systemic or intracranial bleeding

Time frame
systemic or intracranial bleeding will be assessed during 6 month follow-up.
2

occurrence of ischemic stroke or transient ischemic attack

Time frame
during 6 month follow-up
3

Neurological function

Neurological function will be assessed by NIHSS (National institute of health stroke scale)

Time frame
Neurological function will be assessed at baseline, 1 week, 3 months and 6-month after recruitment.
4

Brain MRI (magnetic resonance imaging)

Brain MRI to evaluate whiter matter hyperintensities.

Time frame
Brain MR will be performed at baseline and at 6 months after recruitment

Other outcomes

Sponsors and contacts

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