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NCT Number: NCT06545734

Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion

The goal of this clinical trial is to determine if direct ischemic post-conditioning (IPostC) can alleviate ischemic-reperfusion injury (I/R) in patients who have undergone endovascular thrombectomy (EVT). Additionally, the study aims to explore the underlying mechanisms of direct IPostC.

The primary questions this trial seeks to answer are:

1. Is direct IPostC effective for acute stroke patients with large vessel occlusion? 2. What are the underlying mechanisms of direct IPostC?

Participants will be randomly assigned to one of two groups: an EVT alone group or an EVT plus direct IPostC group. Direct IPostC will be administered immediately after EVT through four cycles of mechanical interruptions of reperfusion. We will evaluate outcomes based on final infarct volume, infarct volume growth, clinical parameters, and I/R-related imaging and laboratory biomarkers. Additionally, an exploratory multi-omics analysis will be conducted to uncover the detailed mechanisms of direct IPostC.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Conditioning Nervous System Diseases Neuroprotection Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300070, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic stroke confirmed by CT or MRI.
  • Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).
  • Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.
  • The patient or legally authorized representative has signed an informed consent form.

Exclusion criteria

  • Inability to perform an MRI or CT scan for any reason.
  • Presence of any condition that would interfere with neurological assessment or any psychiatric disorders.
  • Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline.
  • Pregnancy.
  • Presence of other serious, advanced, or terminal illnesses.

Treatment and study plan

Direct Ischemic Post-conditioning

Procedure

After thrombectomy, the balloon was inflated to a pressure of no more than 4 atm at the occlusion site to block blood flow for 2 minutes, as confirmed by angiography. The balloon was then deflated, allowing blood flow to resume for 2 minutes. These steps were repeated four times.

Endovascular therapy

Procedure

Thrombectomy alone.

Primary outcomes

  1. Infarct Volume Growth

    Time frame: 48 (-12/+24) hours after randomization

    Infarct volume at 48 (-12/+24) hours - Infarct volume at baseline

Secondary outcomes

  1. Final infarct volume

    Time frame: 48 (-12/+24) hours after randomization

    Infarct volume at 48 (-12/+24) hours post-randomization.

  2. Immediate postprocedural infarct volume

    Time frame: Within 2 hours after procedure.

    Infarct volume measured within 2 hours after procedure.

  3. Difference in modified Rankin Scale distribution

    Time frame: At 90 days post-randomization.

    The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The distribution of mRS scores (0-6) will be compared between treatment groups.

  4. Difference in modified Rankin Scale of 0-1

    Time frame: At 90 days post-randomization.

    The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The proportion of mRS 0-1 will be compared between treatment groups.

  5. Difference in modified Rankin Scale of 0-2

    Time frame: At 90 days post-randomization.

    The modified Rankin Scale (mRS) is a 7-point ordinal scale ranging from 0 (no disability) to 6 (death). Higher scores indicate worse outcomes. The proportion of mRS 0-2 will be compared between treatment groups.

  6. Occurrence of early neurological improvement

    Time frame: Within 24 hours post-randomization.

    The National Institutes of Health Stroke Scale (NIHSS) is a 42-point ordinal scale ranging from 0 (no stroke symptoms) to 42 (severe stroke). Higher scores indicate worse neurological deficits. Early neurological improvement is defined as a reduction in NIHSS score by ≥8 points.

  7. Longitudinal Change of NIHSS Scores

    Time frame: At 24 hours, 3 days, and 5-7 days post-randomization or at discharge.

    The National Institutes of Health Stroke Scale (NIHSS) is a 42-point ordinal scale ranging from 0 (no stroke symptoms) to 42 (severe stroke). Higher scores indicate worse neurological deficits. NIHSS scores will be serially assessed at specified intervals.

Other outcomes

  1. Blood brain barrier permeability as measured by K-trans value using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)

    Time frame: At 48 (-12/+24) hours post-randomization.

    Ktrans reflects the rate at which contrast agent passes from the intravascular space into the brain tissue and serves as an indicator of BBB disruption. Higher Ktrans values indicate greater BBB permeability and more severe BBB injury.

  2. Multi-omics analysis of protein and metabolite quantitative changes using mass spectrometry-based proteomics and metabolomics

    Time frame: Within 6 hours after randomization

    Protein and metabolite abundances will be normalized and compared between study groups to identify differentially expressed molecules and biological pathways associated with treatment response.

  3. Percentage of platelet-neutrophil aggregates (CD41+CD66b+ cells) measured by flow cytometry

    Time frame: Within 30 minutes after the procedure.

    Higher percentages indicate increased platelet-neutrophil interactions and enhanced thrombo-inflammatory activity.

  4. Percentage of activated platelets (CD41+CD62+ cells) measured by flow cytometry

    Time frame: Within 30 minutes after the procedure.

    Higher percentages indicate increased platelet activation and prothrombotic potential.

  5. Percentage of activated neutrophils (CD11b+ cells) measured by flow cytometry

    Time frame: Within 30 minutes after the procedure.

    Higher percentages indicate greater neutrophil activation and inflammatory response.

  6. R time (reaction time) measured by thromboelastogram (TEG)

    Time frame: Within 30 minutes after the procedure.

    Quantitative assessment of clot initiation dynamics using TEG. R time measures the latency to initial fibrin formation (reported in seconds). Lower values indicate faster clot initiation, while higher values suggest delayed clotting.

  7. K time (clot kinetics) measured by thromboelastogram (TEG)

    Time frame: Within 30 minutes after the procedure.

    Quantitative assessment of clot formation speed using TEG. K time reflects the time from clot initiation to a fixed clot strength (reported in seconds). Lower values indicate faster clot kinetics, while higher values suggest slower clot formation.

  8. Alpha angle measured by thromboelastogram (TEG)

    Time frame: Within 30 minutes after the procedure.

    Quantitative assessment of fibrin polymerization rate using TEG. The alpha angle (reported in degrees) represents the slope of clot strengthening. Higher values indicate faster fibrin cross-linking and clot stability.

  9. MA (maximum amplitude) measured by thromboelastogram (TEG)

    Time frame: Within 30 minutes after the procedure.

    Quantitative assessment of clot strength using TEG. MA (reported in millimeters) measures the maximum clot firmness. Higher values indicate stronger clot structure, while lower values suggest weaker clot integrity.

  10. EPL (estimated percent lysis) measured by thromboelastogram (TEG)

    Time frame: Within 30 minutes after the procedure.

    Quantitative assessment of clot lysis potential using TEG. EPL (reported as a percentage) estimates the percentage of clot lysed after maximum amplitude is reached. Higher values indicate greater fibrinolysis activity.

  11. LY30 (lysis at 30 minutes) measured by thromboelastogram (TEG)

    Time frame: Within 30 minutes after the procedure.

    Quantitative assessment of late-stage clot lysis using TEG. LY30 measures the percentage of clot lysed 30 minutes after maximum amplitude. Higher values indicate increased fibrinolysis over time.

Sponsors and collaborators

Lead sponsor

Tianjin Huanhu Hospital

Other

Registry information

Official study title

Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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