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Recruiting NCT05789823

Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy (PROTECT-2)

Phase II Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mechanical thrombectomy combined with ischemic post-conditioning, Mechanical thrombectomy alone.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy

Overview

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.

Interventions

  • Procedure Mechanical thrombectomy combined with ischemic post-conditioning
    Ischemic post-conditioning will be applied after successful recanalization of the culprit artery achieve by thrombectomy. Ischemic post-conditioning consists of briefly repeated 4 cycles × 2 minutes of occlusion and reperfusion (equal duration) of the initially occluded artery using a balloon.
  • Procedure Mechanical thrombectomy alone
    Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.

Primary outcome measures

  • Infarct volume at 24 hours [Time frame: 24 hours after randomization]
Secondary outcome measures (12)
  • Progression of infarct volume between baseline and 24 hours [Time frame: Baseline and 24 hours after randomization]
  • Progression of perfusion defect from baseline to 24 hours [Time frame: Baseline and 24 hours after randomization]
  • Progression of infarct volume between 2 hours and 24 hours [Time frame: 2 hours after randomization and 24 hours after randomization]
  • Infarct volume at 5 days/at discharge [Time frame: 5 days after randomization or at discharge]
  • The proportion of functional independence at 90 days [Time frame: 90 days after randomization]
  • The proportion of favorable outcome at 90 days [Time frame: 90 days after randomization]
  • The distribution of mRS score at 90 days [Time frame: 90 days after randomization]
  • National Institute of Health Stroke Scale (NIHSS) score at 24 hours [Time frame: 24 hours after randomization]
  • The proportion of early neurological improvement [Time frame: Baseline and 24 hours after randomization]
  • National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge [Time frame: 5 days after randomization or at discharge]
  • Recanalization rate at 24 hours [Time frame: 24 hours after randomization]
  • Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization. [Time frame: 24 hours after randomization]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Huanhu Hospital — Tianjin

Publications

  • 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. PMID 37497674
  • 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. PMID 36523440

Identifiers

NCT: NCT05789823 · PROTECT-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗