Clinical trial NCT04980625: Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Official title: Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Detailed description: In this study, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 18 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* 1) Age≥18 years, regardless of sex;
* 2) Patients with a clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase;
* 3) Pre-thrombolysis NIHSS \>= 4, and \<= 24;
* 4) Premorbid mRS 0-1;
* 5) Signed and dated informed consent is obtained;

Exclusion Criteria:

* 1) Patients who have the contraindication of intravenous thrombolysis with alteplase.
* 2) The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb.
* 3) Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
* 4) Pregnant or lactating women.
* 5) Severe hepatic and renal dysfunction.
* 6) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
* 7) Unwilling to be followed up or treated for poor compliance.
* 8) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission.
* 9) Other conditions that the researchers think are not suitable for the group.

Primary outcomes:
measure: Proportion of patients with Modified Rankin Scale (mRS) Score 0-1
timeFrame: 3 months
Secondary outcomes:
measure: National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT.
timeFrame: 24 hours, 7 days
measure: Barthel Index (BI) at 24 hours, and 7 days after IVT.
timeFrame: 24 hours, 7 days
measure: Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT.
timeFrame: 90±3 days
measure: Frequency of adverse events during follow-up
timeFrame: 90 days
measure: Frequency of Hemorrhagic transformation within 24 hours after IVT.
timeFrame: 24 hours
measure: Mortality within 90 days.
timeFrame: 90 days
measure: Stroke recurrence rate within 90 days.
timeFrame: 90 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: