Acute Ischemic StrokeRIC-LAANCT06775782
Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis
A study testing Remote Ischemic Conditioning (RIC) treatment and Medical Management in people with Acute Ischemic Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Large Artery Atherosclerosis is one of the most prevalent causes of stroke worldwide and is associated with a high risk of disability and recurrent strokes. Remote Ischemic Conditioning (RIC) is a promising therapy, and it has been recommended for further investigation in patients with acute ischemic stroke resulting… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Remote Ischemic Conditioning (RIC) treatment and Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with age from 18 to 85 years old;
- Randomization must be within 48 hours after stroke symptom onset;
- Ischemic stroke confirmed by MRI diffusion-weighted imaging;
- NIHSS score 6-16, or 4-5 with disabling deficits at the time of randomization. The following typically should be considered disabling deficits: Complete hemianopsia (≥2 on NIHSS question 3) or severe aphasia (≥2 on NIHSS question 9), or visual or sensory extinction (≥1 on NIHSS question 11) or any weakness limiting sustained effort against gravity (≥2 on NIHSS question 6 or 7);
- Proven large vessel 50%-99% stenosis or occlusion by MRA, CTA or DSA in cervical or intracranial carotid artery, M1 or M2 segments of the middle cerebral artery, A1 segment of anterior cerebral artery, P1 segment of posterior cerebral artery, vertebral artery, or basilar artery. For patients with single cerebral infarction, when MRA indicates >50% stenosis rather than occlusion, CTA or DSA should be performed to exclude the risk of MRA overestimating stenosis severity. Acute neurological deficit and cerebral infarction are compatible with ischemia in the vascular territory;
- Pre-stroke modified Rankin Scale score (mRS) of 0-1;
- Signed Informed Consent obtained.
Who cannot join
- Thrombolysis or endovascular therapy performed or planned for index event;
- Suspected or confirmed cardioembolic source of stroke: i. The aetiology of cardiogenic embolism with high embolic potential, such as atrial fibrillation, atrial flutter, rheumatic mitral or aortic stenosis, artificial heart valve, left atrial myxoma, valve neoplasm, left ventricular wall thrombus, congestive heart failure, bacterial endocarditis, cardiomyopathy, myocardial infarction within previous 30 days; ii. Multiple cerebral infarctions in more than one vascular territory (e.g., bilateral MCA, or an MCA and a basilar artery) confirmed MRI diffusion-weighted imaging;
- Suspected or confirmed uncommon causes of cerebrovascular disorders: arterial dissection, Moyamoya disease, vasculitis disease, neurosyphilis, radiation induced vasculopathy, fibromuscular dysplasia, benign angiopathy of central nervous system, post-partum angiopathy, suspected vasospastic process, suspected recanalized embolus etc.;
- Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
- Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg after drug treatment);
- Evidence of intracranial tumor (except small meningioma), abscess, arteriovenous malformation;
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- Patients with bleeding propensity: platelet count <50×10^9/L; heparin was administered within 48 hours with APTT≥35s; on anticoagulant therapy with warfarin and International Normalized Ratio (INR) > 1.7;
- Undergoing hemodialysis or peritoneal dialysis, or known severe renal insufficiency with glomerular filtration rate <30 ml/min or serum creatinine >220 mmol/L (2.5mg/dl);
- Respiratory failure, including type I and type II;
- Any contraindication for Remote Ischemic Conditioning: severe soft tissue injury, fracture, peripheral vascular disease, arteriovenous fistula, or venous thrombosis in the upper limbs;
- Severe comorbid condition with life expectancy < 6 months；
- Current participation in any other investigational trial；
- Pregnancy；
- Patients not suitable for this clinical study considered by researchers.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis: A Multi-centered, Open-label, Blind Endpoint, Randomized Controlled Trial
Large Artery Atherosclerosis is one of the most prevalent causes of stroke worldwide and is associated with a high risk of disability and recurrent strokes. Remote Ischemic Conditioning (RIC) is a promising therapy, and it has been recommended for further investigation in patients with acute ischemic stroke resulting from large artery atherosclerosis. The primary objective of this study is to assess the efficacy of RIC in patients suffering from acute moderate ischemic stroke due to large artery atherosclerosis.
Read the detailed description
This multi-centered, open-label, blind endpoint, randomized controlled trial aims to investigate the efficacy of RIC in patients with acute moderate ischemic stroke due to large artery atherosclerosis. A total of 1150 participants (age 18 to 85 years) within 48 hours of symptom onset of acute moderate ischemic stroke (NIHSS score 6-16, or NIHSS score 4-5 with disabling deficits) due to large artery atherosclerosis will be enrolled. Eligible patients will be randomized in a 1:1 ratio into RIC treatment plus medical management versus medical management alone after offering informed consent.
The primary endpoint is excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1, which will be evaluated by independent researchers in the blind state.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Remote Ischemic Conditioning (RIC) treatment, Medical Management
- Keywords
- Acute Ischemic Stroke；Large Artery Atherosclerosis；Remote Ischemic Conditioning therapy; Randomized Controlled Trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Conditioning (RIC) treatmentDevice
RIC will be given twice a day for 10-14 days. RIC will be applied using an automated RIC device. The cuff of the RIC medical device will be placed around the bilateral upper limbs. Five cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes) for a total procedure time of 50 minutes.
Medical ManagementDrug
Patients will receive standard guideline-directed medical therapy, which will include monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic therapy if appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning + Medical Management | Experimental | Patients in this group will receive Remote Ischemic Conditioning plus best medical management. Receives: Device: Remote Ischemic Conditioning (RIC) treatment; Drug: Medical Management |
| Medical Management | Active comparator | Patients in this group will receive best medical management alone. Receives: Drug: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS) 0-1 at 90 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of patients who have suffered from a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead.
Measured: at 90 days after randomization
Secondary outcomes (7)
Modified Rankin Scale (mRS) 0-2 at 90 days
Measured: at 90 days after randomization
Distribution of the Modified Rankin Scale (mRS) at 90 days
Measured: at 90 days after randomization
Early neurological deterioration within 48 hours
Measured: within 48 hours after randomization
Change of NIHSS scores from baseline to 12 days
Measured: at 12 days after randomization
Recurrence of Ischemic stroke within 90 days
Measured: within 90 days after randomization
Quality of life measured by Euro-QoL-5D-5L at 90 days
Measured: at 90 days after randomization
Death due to any cause within 90 days
Measured: within 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start10 Aug 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775782
- Sponsor's protocol ID
- XJTU1AF-CRF-2023-003
- Acronym
- RIC-LAA
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis: A Multi-centered, Open-label, Blind Endpoint, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06775782
- Acronym / sponsor ID
- RIC-LAA / XJTU1AF-CRF-2023-003
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke；Large Artery Atherosclerosis；Remote Ischemic Conditioning therapy; Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Large Artery Atherosclerosis is one of the most prevalent causes of stroke worldwide and is associated with a high risk of disability and recurrent strokes. Remote Ischemic Conditioning (RIC) is a promising therapy, and it has been recommended for further investigation in patients with acute ischemic stroke resulting from large artery atherosclerosis. The primary objective of this study is to assess the efficacy of RIC in patients suffering from acute moderate ischemic stroke due to large artery atherosclerosis.
Detailed description
This multi-centered, open-label, blind endpoint, randomized controlled trial aims to investigate the efficacy of RIC in patients with acute moderate ischemic stroke due to large artery atherosclerosis. A total of 1150 participants (age 18 to 85 years) within 48 hours of symptom onset of acute moderate ischemic stroke (NIHSS score 6-16, or NIHSS score 4-5 with disabling deficits) due to large artery atherosclerosis will be enrolled. Eligible patients will be randomized in a 1:1 ratio into RIC treatment plus medical management versus medical management alone after offering informed consent.
The primary endpoint is excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1, which will be evaluated by independent researchers in the blind state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning + Medical Management | Experimental | Device: Remote Ischemic Conditioning (RIC) treatment, Drug: Medical ManagementPatients in this group will receive Remote Ischemic Conditioning plus best medical management. |
| Medical Management | Active comparator | Drug: Medical ManagementPatients in this group will receive best medical management alone. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female with age from 18 to 85 years old;
- Randomization must be within 48 hours after stroke symptom onset;
- Ischemic stroke confirmed by MRI diffusion-weighted imaging;
- NIHSS score 6-16, or 4-5 with disabling deficits at the time of randomization. The following typically should be considered disabling deficits: Complete hemianopsia (≥2 on NIHSS question 3) or severe aphasia (≥2 on NIHSS question 9), or visual or sensory extinction (≥1 on NIHSS question 11) or any weakness limiting sustained effort against gravity (≥2 on NIHSS question 6 or 7);
- Proven large vessel 50%-99% stenosis or occlusion by MRA, CTA or DSA in cervical or intracranial carotid artery, M1 or M2 segments of the middle cerebral artery, A1 segment of anterior cerebral artery, P1 segment of posterior cerebral artery, vertebral artery, or basilar artery. For patients with single cerebral infarction, when MRA indicates >50% stenosis rather than occlusion, CTA or DSA should be performed to exclude the risk of MRA overestimating stenosis severity. Acute neurological deficit and cerebral infarction are compatible with ischemia in the vascular territory;
Key exclusion criteria (14 listed)
- Thrombolysis or endovascular therapy performed or planned for index event;
- Suspected or confirmed cardioembolic source of stroke: i. The aetiology of cardiogenic embolism with high embolic potential, such as atrial fibrillation, atrial flutter, rheumatic mitral or aortic stenosis, artificial heart valve, left atrial myxoma, valve neoplasm, left ventricular wall thrombus, congestive heart failure, bacterial endocarditis, cardiomyopathy, myocardial infarction within previous 30 days; ii. Multiple cerebral infarctions in more than one vascular territory (e.g., bilateral MCA, or an MCA and a basilar artery) confirmed MRI diffusion-weighted imaging;
- Suspected or confirmed uncommon causes of cerebrovascular disorders: arterial dissection, Moyamoya disease, vasculitis disease, neurosyphilis, radiation induced vasculopathy, fibromuscular dysplasia, benign angiopathy of central nervous system, post-partum angiopathy, suspected vasospastic process, suspected recanalized embolus etc.;
- Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
- Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg after drug treatment);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic Conditioning (RIC) treatmentRIC will be given twice a day for 10-14 days. RIC will be applied using an automated RIC device. The cuff of the RIC medical device will be placed around the bilateral upper limbs. Five cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes) for a total procedure time of 50 minutes. | Device | Remote Ischemic Conditioning + Medical Management |
| Medical ManagementPatients will receive standard guideline-directed medical therapy, which will include monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic therapy if appropriate. | Drug | Medical Management, Remote Ischemic Conditioning + Medical Management |
Primary outcome
Modified Rankin Scale (mRS) 0-1 at 90 days
Time frame: at 90 days after randomization
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of patients who have suffered from a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead.
7 secondary outcomes
Modified Rankin Scale (mRS) 0-2 at 90 days
Time frame: at 90 days after randomization
Distribution of the Modified Rankin Scale (mRS) at 90 days
Time frame: at 90 days after randomization
Early neurological deterioration within 48 hours
Time frame: within 48 hours after randomization
Change of NIHSS scores from baseline to 12 days
Time frame: at 12 days after randomization
Recurrence of Ischemic stroke within 90 days
Time frame: within 90 days after randomization
Quality of life measured by Euro-QoL-5D-5L at 90 days
Time frame: at 90 days after randomization
Death due to any cause within 90 days
Time frame: within 90 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning (RIC) treatment and Medical Management in people with Acute Ischemic Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suhang Shang (+8618092485760, shangsuhang@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) 0-1 at 90 days (time frame: at 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.