Stroke, AcutePhase 2NCT06545734
Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion
A Phase 2 study testing Direct Ischemic Post-conditioning and Endovascular therapy in people with Stroke, Acute and Neuroprotection, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Neuroprotection, Ischemic Conditioning
- What is being tested?
- Direct Ischemic Post-conditioning and Endovascular therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2024to 15 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- 4. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.
- 5. The patient or legally authorized representative has signed an informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial
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:
Read more
- Is direct IPostC effective for acute stroke patients with large vessel occlusion?
- 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.
- Conditions
- Stroke, Acute, Neuroprotection, Ischemic Conditioning
- Being tested
- Direct Ischemic Post-conditioning, Endovascular therapy
- Keywords
- Stroke, Acute; Large Vessel Occlusion; Neuroprotection
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Ischemic Post-conditioningProcedure or surgery
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 therapyProcedure or surgery
Thrombectomy alone.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy | Active comparator | Not described Receives: Procedure: Endovascular therapy |
| Endovascular therapy plus direct ischemic post-conditioning | Experimental | Not described Receives: Procedure: Direct Ischemic Post-conditioning; Procedure: Endovascular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct Volume Growth
Infarct volume at 48 (-12/+24) hours - Infarct volume at baseline
Measured: 48 (-12/+24) hours after randomization
Secondary outcomes (7)
Final infarct volume
Infarct volume at 48 (-12/+24) hours post-randomization.
Measured: 48 (-12/+24) hours after randomization
Immediate postprocedural infarct volume
Infarct volume measured within 2 hours after procedure.
Measured: Within 2 hours after procedure.
Difference in modified Rankin Scale distribution
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.
Measured: At 90 days post-randomization.
Difference in modified Rankin Scale of 0-1
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.
Measured: At 90 days post-randomization.
Difference in modified Rankin Scale of 0-2
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.
Measured: At 90 days post-randomization.
Occurrence of early neurological improvement
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.
Measured: Within 24 hours post-randomization.
Longitudinal Change of NIHSS Scores
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.
Measured: At 24 hours, 3 days, and 5-7 days post-randomization or at discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start12 Sep 2024
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545734
- Sponsor's protocol ID
- TJHH-2024-WM28
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xu Y, Lu D, Liu S, Jiang X, Wang Q, Luo L, Wang S, Wang Y, Xu Z, Wu Z, Wei M. Immunothrombosis Biomarkers and Multi-Omics Profiles After Successful Recanalization in Patients Receiving Ischemic Postconditioning: An Exploratory Analysis of the INSPIRE Trial. Transl Stroke Res. 2026 Nov 3;17(6):119. doi: 10.1007/s12975-026-01513-x.
PubMed 42975765Xu Y, Zhang B, Liu S, Jiang X, Cao C, Wang Q, Xu Z, Liu S, Du K, Wang S, Luo L, Qin X, Fisher M, Tong X, Ji X, Wei M. Ischemic Postconditioning in Patients With Acute Stroke With Successful Recanalization After Endovascular Therapy: A Pilot Randomized Controlled Trial. Stroke. 2026 Jul 16. doi: 10.1161/STROKEAHA.125.056167. Online ahead of print.
PubMed 42460477
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06545734
- Acronym / sponsor ID
- TJHH-2024-WM28
- Conditions
- Stroke, Acute, Neuroprotection, Ischemic Conditioning
- Keywords
- Stroke, Acute; Large Vessel Occlusion; Neuroprotection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is direct IPostC effective for acute stroke patients with large vessel occlusion?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy | Active comparator | Procedure: Endovascular therapy |
| Endovascular therapy plus direct ischemic post-conditioning | Experimental | Procedure: Direct Ischemic Post-conditioning, Procedure: Endovascular therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- 4. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.
- 5. The patient or legally authorized representative has signed an informed consent form.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Ischemic Post-conditioningAfter 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. | Procedure or surgery | Endovascular therapy plus direct ischemic post-conditioning |
| Endovascular therapyThrombectomy alone. | Procedure or surgery | Endovascular therapy, Endovascular therapy plus direct ischemic post-conditioning |
Primary outcome
Infarct Volume Growth
Time frame: 48 (-12/+24) hours after randomization
Infarct volume at 48 (-12/+24) hours - Infarct volume at baseline
7 secondary outcomes
Final infarct volume
Time frame: 48 (-12/+24) hours after randomization
Immediate postprocedural infarct volume
Time frame: Within 2 hours after procedure.
Difference in modified Rankin Scale distribution
Time frame: At 90 days post-randomization.
Difference in modified Rankin Scale of 0-1
Time frame: At 90 days post-randomization.
Difference in modified Rankin Scale of 0-2
Time frame: At 90 days post-randomization.
Occurrence of early neurological improvement
Time frame: Within 24 hours post-randomization.
Longitudinal Change of NIHSS Scores
Time frame: At 24 hours, 3 days, and 5-7 days post-randomization or at discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 42975765Xu Y, Lu D, Liu S, Jiang X, Wang Q, Luo L, Wang S, Wang Y, Xu Z, Wu Z, Wei M. Immunothrombosis Biomarkers and Multi-Omics Profiles After Successful Recanalization in Patients Receiving Ischemic Postconditioning: An Exploratory Analysis of the INSPIRE Trial. Transl Stroke Res. 2026 Nov 3;17(6):119. doi: 10.1007/s12975-026-01513-x.
- Derived from this study: PubMed 42460477Xu Y, Zhang B, Liu S, Jiang X, Cao C, Wang Q, Xu Z, Liu S, Du K, Wang S, Luo L, Qin X, Fisher M, Tong X, Ji X, Wei M. Ischemic Postconditioning in Patients With Acute Stroke With Successful Recanalization After Endovascular Therapy: A Pilot Randomized Controlled Trial. Stroke. 2026 Jul 16. doi: 10.1161/STROKEAHA.125.056167. Online ahead of print.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Direct Ischemic Post-conditioning and Endovascular therapy in people with Stroke, Acute and Neuroprotection, run by Tianjin Huanhu Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct Volume Growth (time frame: 48 (-12/+24) hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545734, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.