Clinical trial NCT06615726: Regular Physical Activity in Patients With Symptomatic Intracranial Arterial Stenosis
Official title: Regular Physical Activity in Patients With Symptomatic Intracranial Arterial Stenosis: a Prospective Randomized Open-label Blinded Endpoint Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: Ischemic stroke
Transient Ischemic Attack
Symptomatic intracranial arterial stenosis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 1300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the effectiveness and safety of regular physical activity in preventing ischemic stroke events in patients with symptomatic intracranial arterial stenosis.

Detailed description: The intracranial atherosclerotic stenosis (ICAS) is a common cause of ischemic stroke, and the result of increasing global burden of stroke. There are significant racial differences in the incidence of ICAS, which account for 8%-10% of stroke causes in North America and 30%-50% in Asia. In China, the incidence of ICAS in patients with ischemic stroke or transient ischemic attack (TIA) is as high as 46.6%. Previous studies have shown that stroke patients with ICAS have more severe symptoms, longer hospital stay and higher stroke recurrence rate, and the recurrence rate of stroke increases with the increase of stenosis degree. In the WASID (Warfarin-Aspirin Symptomatic Intracranial Disease trial and several prospective cohort studies) trial, the risk of recurrent stroke remained high even after aggressive medication and risk factor intervention in ICAS patients.

At present, the treatment of ICAS mainly includes drug therapy and endovascular therapy. Both the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial in 2011 and the VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial in 2015, showed that aggressive medical treatment is more effective and safer than endovascular treatment . A 2018 review comparing stenting versus aggressive medical treatment for symptomatic ICAS also noted that medical treatment remains the preferred treatment for symptomatic ICAS patients compared to endovascular therapy. The results of the CASSISS trial in 2022, showed that endovascular therapy failed to show long-term benefit in severe patients with symptomatic ICAS. However, the above trials also found that even with aggressive medical treatment including dual antiplatelet therapy and intensive management of vascular risk factors, the one-year stroke recurrence rate in patients with symptomatic ICAS is still as high as 20%. This seriously endangers national lives and health, and restricts social and economic development. Therefore, there is an urgent need to explore new treatments to improve patient survival.

Several previous studies have shown that physical activity can reduce the incidence of all-cause stroke, cardiovascular disease and death, but little is known whether it can reduce the recurrence rate of stroke in patients with symptomatic ICAS. A subgroup analysis of the 2016 SAMMPPRIS trial found that in high-risk symptomatic ICAS patients, physical activity significantly reduced the likelihood of recurrent stroke, myocardial infarction, or vascular death. A 2023 cross-sectional study that included NOMAS (Northern Manhattan Study) data showed a strong negative association between physical activity and asymptomatic high-risk ICAS and was not regulated by vascular risk factors. Therefore, this trial conducts a multicenter, randomized, controlled, blinded trial of patients with symptomatic ICAS within 30 days to compare them with a control group that received only secondary stroke prevention health education to determine the association between regular physical activity and stroke recurrence rates within 1 year in patients with symptomatic ICAS.

Eligibility criteria: 1. Inclusion criteria:

1. Age ≥40 years and ≤80 years;
2. Ischemic stroke or TIA (transient ischemic attack) onset ≤30 days;
3. Ischemic stroke or TIA is attributed to 50-99% of the ICAS (internal carotid artery, M1 segment of middle cerebral artery, M2 segment of middle cerebral artery, basilar artery, or vertebral artery; the degree of stenosis is determined by magnetic resonance angiography, computed tomography angiography, digital subtraction angiography using the standards of warfarin-aspirin symptomatic intracranial disease );
4. mRS (modified Rankin Scale)≤4;
5. The patient himself or his legal representative signs the informed consent form.

2. Exclusion criteria:

1. Stroke progression within the past 3 days (defined as an increase in the score of National Institute of Health Stroke Scale ≥4 points or an increase in individual items of ≥2 points).
2. mRS≥1 before the stroke onset.
3. Concurrent osteoarthritis, fracture, lower limb venous thrombosis, unstable angina pectoris, respiratory diseases, limb disabilities, etc., making it theoretically difficult to cooperate with the physical activity plan for this trial.
4. Complicated with motor disorders such as Parkinson\&#39;s disease and Parkinson\&#39;s syndrome.
5. The vessels responsible for this stroke had tandem lesions (more than 50% of extracranial artery stenosis).
6. The vessel responsible for this stroke has undergone intracranial balloon angioplasty and/or stent implantation (except for mechanical thrombectomy and/or aspiration alone).
7. It is expected that intracranial arterial balloon angioplasty and/or stent implantation will be performed on the vessel responsible for the stroke within 3 months.
8. Patients who exercised regularly within the last 6 months. Regular exercise is defined as four or more moderate intensity exercises per week for more than 10 minutes each time or two or more high intensity exercises per week for more than 10 minutes each time.
9. Inability to understand and/or comply with the trial procedures and/or follow-up due to mental illness, cognitive or emotional disorders.
10. Life expectancy is less than one year.
11. Women who are known to be pregnant or nursing, or have a positive pregnancy test;
12. Are participating in other drug or device research.
13. There are other circumstances that investigators consider are not suitable for enrollment.

Primary outcomes:
measure: New ischemic stroke events
timeFrame: 1 year
Secondary outcomes:
measure: New ischemic stroke and transient ischemic attack events in the responsible vessel supply area
timeFrame: 1 year
measure: New ischemic stroke and transient ischemic attack events
timeFrame: 1 year
measure: Hemorrhagic stroke event
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: The proportion of modified Rankin Scale score 0-1 (range, 0 to 6, with higher scores indicating greater disability)
timeFrame: 1 year
measure: The score of min montreal cognitive assessment(range, 0 to 15, with higher scores indicating greater cognition)
timeFrame: 1 year
measure: The score of Euro-QoL-5 Dimension(range, 0 to 100, with higher scores indicating better quality of life)
timeFrame: 1 year
Other outcomes:
measure: Falls
timeFrame: 1 year
measure: All-cause death
timeFrame: 1 year
Locations:
city: Fuyang
country: China
facility: Taihe Hospital of Traditional Chinese Medicine
state: Anhui
city: Huainan
country: China
facility: Huainan Sunshine Xinkang Hospital
state: Anhui
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Anhui
city: Wuhu
country: China
facility: The Second People's Hospital of Wuhu
state: Anhui
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu District Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Sanbo Jiangling Hospital
state: Chongqing
city: Zhangzhou
country: China
facility: Zhangzhou Hospital
state: Fujian
city: Foshan
country: China
facility: Foshan Fifth People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Foshan Nanhai District Sixth People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Brain Hospital Affiliated to Guangzhou Medical University
state: Guangdong
city: Heyuan
country: China
facility: Longchuan Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guizhou
country: China
facility: Hospital 925, Joint Logistics Support Force
state: Guiyang
city: Cangzhou
country: China
facility: Cangzhou People's Hospital of integrated Chinese and Western Medicine, Hebei Province
state: Hebei
city: Shijiazhuang
country: China
facility: Army Military Medical University Officer School affiliated hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan Workers' Hospital
state: Hebei
city: Xingtai
country: China
facility: Ningjin County Hospital
state: Hebei
city: Gongyi
country: China
facility: Gongyi Xinhua Hospital of Traditional Chinese Medicine
state: Henan
city: Kaifeng
country: China
facility: Tongxu First Hospital
state: Henan
city: Nanyang
country: China
facility: Fangcheng County People's Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang City Center Hospital
state: Henan
city: Shangqiu
country: China
facility: Shangqiu First People's Hospital
state: Henan
city: Shangqiu
country: China
facility: Yongcheng Central Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Zhongkang Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhongmou County People's Hospital
state: Henan
city: Zhoukou
country: China
facility: Xihua County People's Hospital
state: Henan
city: Lichuan
country: China
facility: Lichuan Ethnic Chinese Medicine Hospital
state: Hubei
city: Wuhan
country: China
facility: Hubei Third People's Hospital
state: Hubei
city: Yueyang
country: China
facility: Yueyang City People's Court
state: Hubei
city: Liuyang
country: China
facility: Liuyang City Jili Hospital
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Jiujiang
country: China
facility: Jiujiang First People's Hospital
state: Jiangxi
city: Jilin
country: China
facility: Jilin City People's Hospital
state: Jilin
city: Shenyang
country: China
facility: Xinmin People's Hospital
state: Liaoning
city: Tongliao
country: China
facility: Affiliated Hospital of Inner Mongolia University for Nationalities
state: Neimenggu
city: Dezhou
country: China
facility: Shandong University Qilu Hospital Dezhou Hospital
state: Shandong
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan High-tech East District Hospital
state: Shandong
city: Laixi
country: China
facility: Laixi People's Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Rizhao
country: China
facility: Lanshan District People's Hospital
state: Shandong
city: Weifang
country: China
facility: Affiliated Hospital of Shandong Second Medical University
state: Shandong
city: Yantai
country: China
facility: Yantai Fushan District People's Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Tengzhou Central Hospital
state: Shandong
city: Dezhou
country: China
facility: Ningjin County People's Hospital
state: Shangdong
city: Shanghai
country: China
facility: Shanghai Hechuan Rhein Hospital of Traditional Chinese Medicine
state: Shanghai
city: Yantai
country: China
facility: Yantai Yeda Hospital
state: Shan
city: Chengdu
country: China
facility: Sichuan Academy of Sciences Hospital
state: Sichuan
city: Jianyang
country: China
facility: Jianyang City Hospital of Traditional Chinese Medicine
state: Sichuan
city: Yaan
country: China
facility: Ya 'an People's Hospital
state: Sichuan
city: Shihezi
country: China
facility: Shihezi People's Hospital
state: Xinjiang
city: Wenzhou
country: China
facility: Yongjia County People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Yueqing People's Hospital
state: Zhejiang
Study officials:
References: