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

NCT05583266 | Unknown Phase 4 DMC

• 1 other identifier: KY2022-100-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Small Vessel Diseases

Keywords

cerebral small vessel diseases; Pentoxifylline; randomized controlled trial; multicenter study; double blind study; placebo-controlled

Outcome Measures

Primary Outcomes (2)

• The change in cerebral blood flow at 6 months

  TCD is used to evaluate the change in cerebral blood flow (cm/s) 6 months after treatment. Higher speed mean a worse outcome.

  3 months and 6 months after randomization

• The change of middle cerebral artery pulsatility index at 6 months

  TCD is used to evaluate the change of middle cerebral artery pulsatility index at 6 months. Higher pulsatility index mean a worse outcome.

  3 months and 6 months after randomization

Secondary Outcomes (11)

• cognitive function assessed by MoCA at 6 months

  6 months after randomization

• cognitive function assessed by Clinical Dementia Rating (CDR) at 6 months

  6 months after randomization

• The change of White Matter hyperintense volume at 6 months

  6 months after randomization

• The change of White Matter hyperintensities Fazekas scores at 6 months

  6 months after randomization

• The change of Cerebral blood flow values for MRI cerebral perfusion imaging at 6 months

  6 months after randomization

Other Outcomes (3)

• Neurovascular coupling index

  3 months and 6 months after randomization

• Electroencephalogram oscillations

  3 months and 6 months after randomization

• Blood-Brain Barrier (BBB) Permeability between groups.

  3 months and 6 months after randomization

Study Arms (2)

Pentoxifylline sustained- release tablets placebo group

PLACEBO COMPARATOR

This group will receive Pentoxifylline sustained-release tablets placebo, 1 tablet twice a day, from the day of randomization to 6 months.

Drug: Pentoxifylline sustained-release tablets placebo

Pentoxifylline sustained- release tablets group

EXPERIMENTAL

This group will receive Pentoxifylline sustained-release tablets, 1 tablet twice a day, from the day of randomization to 6 months.

Drug: Pentoxifylline sustained-release tablets

Interventions

Pentoxifylline sustained-release tablets DRUG

a dose of 1 tablet twice a day of Pentoxifylline sustained-release tablets

Pentoxifylline sustained- release tablets group

Pentoxifylline sustained-release tablets placebo DRUG

Pentoxifylline sustained-release tablets placebo will be administrated at the same dosage and frequency as the experimental group

Pentoxifylline sustained- release tablets placebo group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-75 years;
• 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;
• is eligible for Transcranial Doppler (TCD) monitoring;
• 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;
• independent in daily life (modified mRS ≤2) ;
• with signed informed consent.

You may not qualify if:

• patients with acute cerebral infarction and acute cerebral hemorrhage;
• 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;
• 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.;
• patients with acute coronary syndrome and severe coronary arteriosclerosis;
• 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) ;
• patients who are pregnant, lactating or likely to become pregnant and planning to become pregnant;
• patients with refractory hypertension;
• patients with known allergic history to pentoxifylline, methylxanthine (such as caffeine, aminophylline, dihydroxypropyltheophylline, etc.) ;
• 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;
• 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;
• Patients with other life-threatening or serious diseases with an expected survival of \< 36 months;
• Patients with contraindications to MRI;
• Patients who could not cooperate to complete the follow-up;
• Patients who enrolled in other clinical trials within 30 days.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100050, China

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yilong Wang, PhD，MD

  Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yilong Wang, PhD，MD

CONTACT

0086-10-59975178; yilong528@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Beijing Tiantan Hospital

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: November 1, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 31, 2024
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

CN (1)