Evaluating antiplatelet therapy for cerebral small vessel diseases

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

This study is testing if different blood-thinning medications can help people aged 30 to 79 with small vessel disease in the brain feel better and improve their condition.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 30 Years to 79 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06715007 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effects of different antiplatelet agents, including cilostazol and isosorbide mononitrate, on patients with cerebral small vessel disease (cSVD), particularly those with recent small subcortical infarcts or white matter hyperintensities. The study will involve a cohort of patients aged 30 to 79 years, focusing on the relationship between endothelial dysfunction and cSVD. Participants will be monitored for changes in their condition and response to treatment over time, utilizing neuroimaging techniques to evaluate outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 30 to 79 years who have experienced a recent small subcortical infarct or have white matter hyperintensities.

Not a fit: Patients with significant cortical dysfunction or other vascular pathologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from cerebral small vessel disease, potentially reducing the risk of ischemic strokes and cognitive decline.

How similar studies have performed: While there is limited research specifically targeting cSVD, previous studies on antiplatelet therapy in ischemic stroke have shown mixed results, indicating that this approach may be novel and requires further exploration.

Eligibility criteria

Inclusion criteria:

1. Age ≥ 30 years and ≤ 79 years.
2. 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.
3. Absence of signs or symptoms of cortical dysfunction, such as aphasia, apraxia, agnosia, agraphia, homonymous visual field defect.
4. Modified Rankin score of ≤ 4.
5. In the absence of any other pathology in the parent artery at the site of the origin of the penetrating artery (focal atheroma, parent vessel dissection, vasculitis, vasospasm, and so on).

7\. No ipsilateral cervical carotid stenosis (≥30%) by brain high resolution magnetic resonance imaging (HRMRI) or computed tomography angioplasty (CTA) or (magnetic resonance angioplasty) MRA and cervical artery ultrasound, if qualifying event is hemispheric. No vertebra artery stenosis (≥30%) by brain HRMRI or CTA or MRA and cervical artery ultrasound, if the lesion is in the territory of posterior circulation.

8\. No major-risk cardioembolic sources requiring anticoagulation or other specific therapy.

9\. Patient agrees with follow-up visits and is available by phone. 10. Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.

Exclusion criteria:

1. 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.
2. Active cardiac disease (atrial fibrillation, myocardial infarct in last six months, active angina, symptomatic cardiac failure).
3. History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural).
4. Known allergy or contraindication to aspirin, clopidogrel, cilostazol, isosorbide mononitrate or statin.
5. Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets \< 100,000, hematocrit \< 30, international normalized ratio (INR) \> 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure \> 180 mm Hg or diastolic pressure \> 115 mm Hg), severe liver impairment (aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \> 3 x normal, cirrhosis), creatine kinase \> 5 times the upper limit of normal (ULN) at final screening, severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \< 20mL/min/1.73 square meter at final screening.
6. Major surgery (including open femoral, aortic, cardiac or carotid surgery) within previous 30 days or planned in the 1 year after enrollment.
7. Dementia or psychiatric problem that prevents the patient from relevant evaluation or follow-up reliably.
8. Co-morbid conditions that may limit survival to less than 1 year.
9. Currently breastfeeding, pregnancy, planning to become pregnant and unwilling to use contraception for the duration of this study
10. Unable to tolerate, or contraindication to, MRI.
11. Enrollment in another study that would conflict with the current study.

Where this trial is running

Nanjing, Jiangsu

• the First affiliated hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhaolu Wang, MD

Conditions Stroke, Ischemic; Small Vessel Cerebrovascular Disease; White Matter Hyperintensity; cerebral small vessel disease; recent small subcortical infarcts; Endothelial dysfunction; cilostazol