Efficacy of Pentoxifylline on Cerebrovascular Function in Patients With Cerebral Small Vessel Disease(PERFORM)

• Status: Not yet recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blinded, placebo-controlled, multi-center trial. Cerebral small vessel disease (CSVD) patients will be diagnosed according to STRIVE standards and randomized into the Pentoxifylline sustained-release tablet group and placebo group. The purpose of this trial is to assess the efficacy of Pentoxifylline sustained- release tablets on CSVD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Pentoxifylline

Criteria

Inclusion Criteria:

1. Age 45-75 years;

2. CSVD can be seen on MRI, which satisfies one of the following conditions:

• Presence of white matter hyperintensities and Fazekas score ≥2;

• Lacunar Infarction ≥1, with or without white matter hyperintensities;

3. is eligible for Transcranial Doppler (TCD) monitoring;

4. meeting the following clinical manifestations:

• Patients with vascular cognitive impairment (abnormalities in memory and or other cognitive domains lasting at least 3 months) ;

• MoCA ≤22 points; MoCA ≤21 points for primary education and below;

5. independent in daily life (modified mRS ≤2) ;

6. with signed informed consent.

Exclusion Criteria:

1. patients with acute cerebral infarction and acute cerebral hemorrhage;

2. patients with bleeding tendency: including platelet count < 100 × 10*9/L, active peptic ulcer, history of intracranial hemorrhage (such as epidural hematoma, subdural haematoma, subarachnoid hemorrhage, cerebral hemorrhage, etc.) , cerebral microbleedings (≥5 cerebral microbleedings) , brain tumor, cancer-related stroke, taking anticoagulant drugs, or using dual antiplatelet therapy;

3. patients who have a history of cognitive impairment caused by other causes, such as normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.;

4. patients with acute coronary syndrome and severe coronary arteriosclerosis;

5. patients with severe hepatic insufficiency, renal insufficiency, or severe cardiac insufficiency before randomization (severe hepatic insufficiency refers to ALT ≥2.0 times the upper limit of normal or AST ≥2.0 times the upper limit of normal; severe renal insufficiency refers to CRE ≥1.5 times the upper limit of normal or EGFR < 40 ml/min/1.73 m2; severe cardiac insufficiency refers to NYHA grade of 3-4) ;

6. patients who are pregnant, lactating or likely to become pregnant and planning to become pregnant;

7. patients with refractory hypertension;

8. patients with known allergic history to pentoxifylline, methylxanthine (such as caffeine, aminophylline, dihydroxypropyltheophylline, etc.) ;

9. patients with use of other vasodilators or circulatory improvers within 1 week (e.g. Cilostazol, Vinpocetine, Dimitamol, Sildenafil, Butylphthalide, Betahistine, Uracillin, Alprostadil, etc.) May stop taking the drug for 1 week before enrolling if criteria are met;

10. Patients using other drugs that affect the safety or efficacy evaluation of the tiral drug and who do not agree to discontinue the drug, such as GLP-1 receptor agonists, Liraglutide, dulasapeptide, risperidone, and exenatide;

11. Patients with other life-threatening or serious diseases with an expected survival of < 36 months;

12. Patients with contraindications to MRI;

13. Patients who could not cooperate to complete the follow-up;

14. Patients who enrolled in other clinical trials within 30 days.