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

NCT05789823 | Recruiting Phase 2 DMC

• 1 other identifier: PROTECT-2
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Infarct volume at 24 hours

  Infarct volume on MRI-DWI at 24 hours after randomization

  24 hours after randomization

Secondary Outcomes (12)

• Progression of infarct volume between baseline and 24 hours

  Baseline and 24 hours after randomization

• Progression of perfusion defect from baseline to 24 hours

  Baseline and 24 hours after randomization

• Progression of infarct volume between 2 hours and 24 hours

  2 hours after randomization and 24 hours after randomization

• Infarct volume at 5 days/at discharge

  5 days after randomization or at discharge

• The proportion of functional independence at 90 days

  90 days after randomization

Other Outcomes (5)

• Safety outcome (mortality at 90 days)

  90 days after randomization

• Safety outcome (the proportion of symptomatic intracranial hemorrhage within 24 hours)

  Within 24 hours after randomization

• Safety outcome (the proportion of intracranial hemorrhage within 24 hours)

  Within 24 hours after randomization

Study Arms (2)

Ischemic post-conditioning group

EXPERIMENTAL

Mechanical thrombectomy combined with ischemic post-conditioning

Procedure: Mechanical thrombectomy combined with ischemic post-conditioning

Control group

SHAM COMPARATOR

Mechanical thrombectomy alone

Procedure: Mechanical thrombectomy alone

Interventions

Mechanical thrombectomy combined with ischemic post-conditioning PROCEDURE

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.

Ischemic post-conditioning group

Mechanical thrombectomy alone PROCEDURE

Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300350, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xunming Ji, MD

CONTACT

010-83198952; jixm@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)