NCT06775782

Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis

Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis: A Multi-centered, Open-label, Blind Endpoint, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,150 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Remote Ischemic Conditioning (RIC) treatment	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.
DRUG	Medical Management	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.

Timeline

• Start date: 2025-08-10
• Primary completion: 2027-07-31
• Completion: 2027-08-31
• First posted: 2025-01-15
• Last updated: 2025-08-14

Locations

1 site across 1 country: China