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Moyamoya DiseaseMOUNT-EASENCT07762547

Evaluating Antiplatelet and Physical Therapy for Slowing Progression in Mild Moyamoya Disease.

A study testing aspirin treatment and Remote Ischemic Conditioning in people with Moyamoya Disease and Moyamoya Syndrome, run by Beijing Tiantan Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Moyamoya disease (MMD) is a chronic occlusive cerebrovascular disease characterized by progressive stenosis or occlusion at the terminal portion of the internal carotid artery, with formation of an abnormal vascular network at the base of the brain. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Moyamoya Disease, Moyamoya Syndrome, Aspirin
What is being tested?
aspirin treatment and Remote Ischemic Conditioning
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
724 participants
Where
1 siteChina
Study dates
15 Jul 2026to 28 Feb 2030
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

History of any form of intracranial hemorrhage, including subarachnoid hemorrhage, intracerebral hemorrhage, intraventricular hemorrhage, etc.; history of symptomatic ischemic stroke; frequent transient ischemic attacks (TIAs) before enrollment, defined as ≥3 episodes within 7 days; or history of epileptic seizures.

Concomitant cerebrovascular diseases that may significantly affect perioperative risk or outcome assessment, such as intracranial aneurysms requiring concomitant treatment, cerebral arteriovenous malformations, arteriovenous fistulas, or other relevant cerebrovascular lesions.

History of severe traumatic brain injury, brain tumor, encephalitis, meningitis, or other inflammatory diseases of the central nervous system; other major intracranial diseases; any prior invasive intracranial treatment; or history of cranial radiotherapy.

Planned cerebral revascularization surgery within 3 months. Severe cardiac dysfunction (left ventricular ejection fraction <50% or New York Heart Association [NYHA] class III-IV), hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the upper limit of normal), or renal dysfunction (serum creatinine >1.5 times the upper limit of normal); major systemic diseases such as unstable angina, acute coronary syndrome, asthma, or chronic obstructive pulmonary disease (COPD); severe noncardiovascular comorbidities with an expected survival of <1 year; or any other serious comorbidity considered by the investigator to significantly increase study-related risk.

Contraindications to aspirin, including:

  1. Known allergy to aspirin;
  2. Severe renal dysfunction (serum creatinine >1.5 times the upper limit of normal) or severe hepatic dysfunction (ALT or AST >2 times the upper limit of normal);
  3. Severe heart failure (NYHA class III-IV);
  4. Coagulation disorders or a history of systemic bleeding;
  5. History of thrombocytopenia or neutropenia;
  6. History of drug-induced hematologic disorders or hepatic injury;
  7. White blood cell count <2×10⁹/L or platelet count <100×10⁹/L;
  8. History of gastrointestinal bleeding within 3 months before enrollment, or a documented history of gastric ulcer or gastritis;
  9. Any other contraindication to aspirin.

Contraindications to remote ischemic conditioning (RIC), including:

  1. Peripheral vascular disease of the upper or lower extremities, particularly significant stenosis or occlusion of the brachial, ulnar, or radial arteries, or any condition considered by the investigator to make upper-arm cuff inflation for RIC unsuitable;
  2. Conditions that may affect the safety of upper-limb RIC, including but not limited to severe skin or soft-tissue infection or injury, marked lymphedema, arteriovenous fistula or dialysis fistula, recent deep venous thrombosis, or inability to tolerate upper-arm cuff inflation as judged by the investigator, such as severe pain or recurrent subcutaneous bleeding;
  3. Known allergy to the RIC device or any of its component materials. Requirement for aspirin and/or other antiplatelet therapy because of diseases other than moyamoya disease, such as systemic, circulatory, or hematologic disorders; or continuous use of other antiplatelet agents for ≥5 days before enrollment, with the last dose administered within 10 days before enrollment.

Requirement for anticoagulant therapy, including conditions such as atrial fibrillation, prosthetic heart valves, known or suspected endocarditis, venous thrombosis, or other diseases requiring anticoagulation; or use of heparin or oral anticoagulants within 10 days before enrollment.

Pregnancy, suspected pregnancy (defined as a positive pregnancy test in a woman of childbearing potential who has not used effective contraception), or breastfeeding.

Conditions that may interfere with completion of key follow-up assessments, such as severe cognitive impairment or psychiatric disorders resulting in inability to cooperate with study evaluations, or a clear expectation that follow-up cannot be completed.

Current participation in another interventional clinical trial that, in the investigator's judgment, may interfere with assessment of the study outcomes

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

    Yan Zhang, MD, 010-59978316, yanzhang166@163.com

    Yahui Zhao, MD, 010-59978316, yahuii.zhao@hotmail.com

Other trials in China

About this study

Official title: Study on the Effects of Pharmacological and Physical Therapy in Delaying the Progression of Moyamoya Disease (Moyamoya Syndrome) : Randomized Controlled Study

Moyamoya disease (MMD) is a chronic occlusive cerebrovascular disease characterized by progressive stenosis or occlusion at the terminal portion of the internal carotid artery, with formation of an abnormal vascular network at the base of the brain. Moyamoya syndrome (MMS) has the same cerebrovascular imaging and clinical manifestations as moyamoya disease, but it is accompanied by other systemic comorbidities. Moyamoya disease and moyamoya syndrome are collectively referred to as moyamoya-like cerebrovascular disease. They are highly prevalent in East Asia, and China has a large patient population. In 2018, the incidence was 1.6 per 100,000 person-years, and the disease is a major cause of stroke in children, adolescents, and young adults [1]. This group of diseases often causes severe complications such as stroke and cognitive impairment, leading to poor prognosis and reduced ability to live independently [2]. Among patients who do not receive effective treatment, the risk of severe neurological deficit or death is as high as 75%, and approximately 60% of patients with moyamoya disease develop cognitive impairment [3]. Therefore, moyamoya disease (moyamoya syndrome) is a major health problem that seriously affects the health of the Chinese population.

At present, several urgent problems remain in the clinical diagnosis and treatment of moyamoya disease (moyamoya syndrome). First, the epidemiological characteristics and disease susceptibility of this condition in the Chinese population are not yet fully clear. Second, reliable clinical assessment tools and standardized risk prediction models for moyamoya disease are lacking, and there is still no clear basis for identifying which patients need timely intervention. Third, a systematic precision treatment pathway for moyamoya disease has not yet been established, and high-quality evidence is still lacking regarding the role of pharmacological and physical therapy in delaying disease progression. Therefore, systematic research to clarify the efficacy of different treatment approaches in moyamoya disease is of great significance for promoting the establishment of an integrated diagnostic and therapeutic system for this disease.

Read more

[Add a paragraph introducing ischemic conditioning and its role in stroke and MMD.] Systematic treatment is an important means to improve the prognosis of moyamoya disease. Current major treatment options include revascularization surgery and pharmacological therapy. Previous studies have shown that revascularization surgery can improve cerebral blood flow and reduce the risk of stroke; however, for asymptomatic or early-stage patients, surgery is not the only option [4]. In terms of pharmacological therapy, nonsurgical treatments such as antiplatelet therapy and intensive lipid-lowering therapy may delay disease progression, but high-quality clinical evidence remains lacking. In addition, emerging physical therapies such as ischemic conditioning have been shown to improve the tolerance of brain tissue to ischemia and have demonstrated potential therapeutic value in patients with stroke [5]. However, the safety and efficacy of these treatment approaches in patients with moyamoya disease require further study and validation.

Therefore, this study proposes to conduct a multicenter, prospective randomized controlled clinical trial to systematically evaluate the efficacy and safety of aspirin therapy and ischemic conditioning therapy in delaying the progression of moyamoya disease, and to provide evidence-based support for nonsurgical treatment strategies for patients with moyamoya disease.

[The following content was moved from the study rationale section and should be integrated with the research background.] Even when patients with moyamoya disease (moyamoya syndrome) have not yet developed definite symptoms of cerebral infarction, their cerebral hemodynamics may already be in a compensated or critical state. They are often prone to nonspecific symptoms such as headache and dizziness, subjective cognitive decline, and TIA attacks, and they have a potential risk of progression to symptomatic stroke. Microembolus formation and vascular endothelial dysfunction may further reduce flow reserve and aggravate hypoperfusion, thereby leading to adverse events. For such mildly affected patients, early intervention has important clinical value for delaying disease progression and preventing cerebrovascular events.

Aspirin irreversibly inhibits cyclooxygenase-1 and blocks thromboxane A2 production, thereby inhibiting platelet aggregation. In the pathological process of moyamoya disease (moyamoya syndrome), microcirculatory changes and vascular intimal injury may activate platelets and promote microthrombus formation, which may aggravate ischemia-induced stroke. Therefore, aspirin may reduce the risk of ischemic events by inhibiting platelet aggregation. Ischemic conditioning is a noninvasive physical therapy that activates systemic endogenous protect

Being tested
aspirin treatment, Aspirin placebo, Remote Ischemic Conditioning, Sham remote ischemic conditioning
Medical subject headings
Moyamoya Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aspirin treatmentDrug

    Aspirin will be taken orally every morning for 1 year. To ensure medication adherence, study drugs will be dispensed and regularly recovered for pill counting.

    Aspirin: 100 mg, orally on an empty stomach in the morning, once daily;

  • Aspirin placeboDrug

    Aspirin placebo will be taken orally every morning for 1 year. To ensure medication adherence, study drugs will be dispensed and regularly recovered for pill counting.

    Placebo: consistent with aspirin in dosage form, dose, packaging, and appearance; 100 mg, orally on an empty stomach in the morning, once daily.

  • Remote Ischemic ConditioningDevice

    The first 3 months after randomization will be the intensive phase, during which ischemic conditioning will be completed once daily. Months 4 to 6 after randomization will be the maintenance phase, during which ischemic conditioning will be completed no fewer than 4 times per week, with a maximum of once per day.

    Real ischemic conditioning procedure group: the ischemic conditioning device will be used once daily, including 5 treatment cycles. After blood pressure is measured in both arms, the upper limit of the bilaterally measured blood pressure will be used as the inflation value. The cuffs on both upper limbs will be inflated and maintained for 5 minutes, followed by deflation for 5 minutes. Each treatment session will last 45 minutes.

  • Sham remote ischemic conditioningDevice

    The first 3 months after randomization will be the intensive phase, during which sham procedure treatment will be completed once daily. Months 4 to 6 after randomization will be the maintenance phase, during which sham procedure treatment will be completed no fewer than 4 times per week, with a maximum of once per day Sham ischemic conditioning procedure group: the sham ischemic conditioning device will be used once daily, including 5 treatment cycles. The cuffs on both upper limbs will be inflated to 60 mmHg and maintained for 5 minutes, followed by deflation for 5 minutes. Each treatment session will last 45 minutes.

Study groups in NCT07762547
Study groupRoleWhat they receive
control groupOtheraspirin placebo + sham ischemic conditioning procedure
Receives: Drug: Aspirin placebo; Device: Sham remote ischemic conditioning
group 1Otheraspirin treatment + sham ischemic conditioning procedure
Receives: Drug: aspirin treatment; Device: Sham remote ischemic conditioning
group 2Otheraspirin placebo + ischemic conditioning
Receives: Drug: Aspirin placebo; Device: Remote Ischemic Conditioning
group 3Experimentalaspirin treatment + ischemic conditioning
Receives: Drug: aspirin treatment; Device: Remote Ischemic Conditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy endpoint event

    The primary efficacy endpoint event is disease progression or the occurrence of a cerebrovascular event within 1 year, including transient ischemic attack and cerebral infarction.

    Measured: 1 year

Secondary outcomes (7)
  1. Secondary endpoint events

    New vascular events within 1 year, including transient ischemic attack, cerebral infarction, cerebral hemorrhage, myocardial infarction, and vascular death; each new vascular event will also be evaluated independently;

    Measured: 1 year

  2. Secondary endpoint events

    Disabling stroke events within 1 year (mRS score > 1);

    Measured: 1 year

  3. Secondary endpoint events

    Occurrence and severity of stroke or transient ischemic attack at 3 months and 1 year; severity will be classified according to an ordered 6-level scale combined with the mRS: fatal stroke / severe nonfatal stroke [mRS 4 or 5] / severe nonfatal stroke [mRS 4 or 5] / moderate stroke [mRS 2 or 3] / mild stroke [mRS 0 or 1] / TIA / no stroke-TIA;

    Measured: 3 months and 1 year

  4. Secondary endpoint events

    Change in neurological deficit at 3 months, compared with baseline, based on the change in mRS score at the 3-month follow-up;

    Measured: 3 months

  5. Secondary endpoint events

    Quality of life at the 3-month and 1-year follow-up visits, assessed using the EQ-5D-5L scale.

    Measured: 3 months and 1 year

  6. Secondary endpoint events

    Average monthly frequency of TIA attacks within 1 year.

    Measured: 1 year

  7. Secondary endpoint events

    Progression of white matter hyperintensity (WMH) lesions within 1 year

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion28 Feb 2030 (estimated)
  4. Study completion28 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
724 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07762547
Sponsor's protocol ID
12110000400686320W
Other IDs
2026ZD0554900
Acronym
MOUNT-EASE
Status last verified
Mar 2026
First submitted
9 Aug 2026
Last updated
13 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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