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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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:
- Known allergy to aspirin;
- 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);
- Severe heart failure (NYHA class III-IV);
- Coagulation disorders or a history of systemic bleeding;
- History of thrombocytopenia or neutropenia;
- History of drug-induced hematologic disorders or hepatic injury;
- White blood cell count <2×10⁹/L or platelet count <100×10⁹/L;
- History of gastrointestinal bleeding within 3 months before enrollment, or a documented history of gastric ulcer or gastritis;
- Any other contraindication to aspirin.
Contraindications to remote ischemic conditioning (RIC), including:
- 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;
- 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;
- 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
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 group | Role | What they receive |
|---|---|---|
| control group | Other | aspirin placebo + sham ischemic conditioning procedure Receives: Drug: Aspirin placebo; Device: Sham remote ischemic conditioning |
| group 1 | Other | aspirin treatment + sham ischemic conditioning procedure Receives: Drug: aspirin treatment; Device: Sham remote ischemic conditioning |
| group 2 | Other | aspirin placebo + ischemic conditioning Receives: Drug: Aspirin placebo; Device: Remote Ischemic Conditioning |
| group 3 | Experimental | aspirin 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.
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)
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
Secondary endpoint events
Disabling stroke events within 1 year (mRS score > 1);
Measured: 1 year
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
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
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
Secondary endpoint events
Average monthly frequency of TIA attacks within 1 year.
Measured: 1 year
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.
- First posted13 Aug 2026
- Study start15 Jul 2026 (estimated)
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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