Clinical trial NCT05789823: Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)
Official title: Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 160
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: Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
3. Previous mRS ≤ 2;
4. Baseline NIHSS ≥ 6;
5. Baseline ASPECTS ≥ 6;
6. Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion;
7. Successful recanalization after mechanical thrombectomy (eTICI 2b-3);
8. Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

1. Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
2. Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
3. Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
4. Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
5. \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
6. Patients with contraindications to MRI;
7. Other conditions that the investigator considered inappropriate for inclusion.

Primary outcomes:
measure: Infarct volume at 24 hours
timeFrame: 24 hours after randomization
Secondary outcomes:
measure: Progression of infarct volume between baseline and 24 hours
timeFrame: Baseline and 24 hours after randomization
measure: Progression of perfusion defect from baseline to 24 hours
timeFrame: Baseline and 24 hours after randomization
measure: Progression of infarct volume between 2 hours and 24 hours
timeFrame: 2 hours after randomization and 24 hours after randomization
measure: Infarct volume at 5 days/at discharge
timeFrame: 5 days after randomization or at discharge
measure: The proportion of functional independence at 90 days
timeFrame: 90 days after randomization
measure: The proportion of favorable outcome at 90 days
timeFrame: 90 days after randomization
measure: The distribution of mRS score at 90 days
timeFrame: 90 days after randomization
measure: National Institute of Health Stroke Scale (NIHSS) score at 24 hours
timeFrame: 24 hours after randomization
measure: The proportion of early neurological improvement
timeFrame: Baseline and 24 hours after randomization
measure: National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge
timeFrame: 5 days after randomization or at discharge
measure: Recanalization rate at 24 hours
timeFrame: 24 hours after randomization
measure: Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization.
timeFrame: 24 hours after randomization
Other outcomes:
measure: Safety outcome (mortality at 90 days)
timeFrame: 90 days after randomization
measure: Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours)
timeFrame: Within 24 hours after randomization
measure: Safety outcome (the proportion of intracranial hemorrhage within 24 hours)
timeFrame: Within 24 hours after randomization
measure: Safety outcome (the proportion of malignant brain edema within 24 hours)
timeFrame: Within 24 hours after randomization
measure: Procedure-related complications
timeFrame: During the procedure
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
References:
citation: Wu L, Wei M, Zhang B, Zhang B, Chen J, Wang S, Luo L, Liu S, Li S, Ren C, Hess DC, Song H, Zhao W, Ji X. Safety and Tolerability of Direct Ischemic Postconditioning Following Thrombectomy for Acute Ischemic Stroke. Stroke. 2023 Sep;54(9):2442-2445. doi: 10.1161/STROKEAHA.123.044060. Epub 2023 Jul 27.
citation: Wu L, Zhang B, Zhao W, Ji X, Wei M. Ischemic post-conditioning in acute ischemic stroke thrombectomy: A phase-I duration escalation study. Front Neurosci. 2022 Dec 8;16:1054823. doi: 10.3389/fnins.2022.1054823. eCollection 2022.