Acute Ischemic StrokePhase 2NCT05789823

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

A Phase 2 study testing Mechanical thrombectomy combined with ischemic post-conditioning and Mechanical thrombectomy alone in people with Acute Ischemic Stroke, run by Capital Medical University at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Ischemic Stroke
What is being tested?: Mechanical thrombectomy combined with ischemic post-conditioning and Mechanical thrombectomy alone
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 6 sitesChina
Study dates: 1 Nov 2023to 16 Aug 2026
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
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

The First Hospital of Jilin University
Changchun, Jilin, 130031
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300350
Tianjin Fifth Central Hospital
Tianjin, Tianjin Municipality, 300450
Xingtai Central Hospital
Xingtai, Hebei, 054001
Qinghe People's Hospital
Xingtai, Hebei, 054899

Other trials in China

About this study

Official title: Efficacy and Safety of Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

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
Being tested: Mechanical thrombectomy combined with ischemic post-conditioning, Mechanical thrombectomy alone
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mechanical thrombectomy combined with ischemic post-conditioningProcedure or surgery
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.
Mechanical thrombectomy aloneProcedure or surgery
Successful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.

Study groups in NCT05789823
Study group	Role	What they receive
Ischemic post-conditioning group	Experimental	Mechanical thrombectomy combined with ischemic post-conditioning Receives: Procedure: Mechanical thrombectomy combined with ischemic post-conditioning
Control group	Sham comparator	Mechanical thrombectomy alone Receives: Procedure: Mechanical thrombectomy alone

What is being measured

The primary outcome is the main question the study is designed to answer.

Infarct volume at 24 hours
Infarct volume on MRI-DWI at 24 hours after randomization
Measured: 24 hours after randomization

Secondary outcomes (12)

Progression of infarct volume between baseline and 24 hours
Difference of infarct volume on MRI-DWI between baseline and 24 hours after randomization
Measured: Baseline and 24 hours after randomization
Progression of perfusion defect from baseline to 24 hours
The volume difference of Tmax > 6 s from baseline to 24 hours after randomization
Measured: Baseline and 24 hours after randomization
Progression of infarct volume between 2 hours and 24 hours
Difference of infarct volume on MRI-DWI between 2 h after randomization and 24 h after randomization
Measured: 2 hours after randomization and 24 hours after randomization
Infarct volume at 5 days/at discharge
Infarct volume on CT/MRI-FLAIR at 5 days after randomization/at discharge
Measured: 5 days after randomization or at discharge
The proportion of functional independence at 90 days
The modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: 90 days after randomization
The proportion of favorable outcome at 90 days
The mRS score of 0-3 at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: 90 days after randomization
The distribution of mRS score at 90 days
The distribution of the mRS score at 90 days after randomization; the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Measured: 90 days after randomization
National Institute of Health Stroke Scale (NIHSS) score at 24 hours
NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Measured: 24 hours after randomization
The proportion of early neurological improvement
NIHSS 0-2 or ≥ 8 lower than baseline NIHSS score at 24 hours after randomization; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Measured: Baseline and 24 hours after randomization
National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge
NIHSS score at 5 days after randomization/at discharge; the NIHSS ranges from 0 to 42, with higher scores indicating more severe neurologic deficits
Measured: 5 days after randomization or at discharge
Recanalization rate at 24 hours
Recanalization rate at 24 hours after randomization (eTICI 2b-3)
Measured: 24 hours after randomization
Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization.
Cerebral blood flow will be assessed by transcranial Doppler ultrasound at 24 hours after randomization
Measured: 24 hours after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202316 Aug 2026

First posted29 Mar 2023
Study start1 Nov 2023
Primary completion16 May 2026
Study completion16 Aug 2026

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 Acute Ischemic StrokeStudies 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: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05789823
Sponsor's protocol ID: PROTECT-2
Status last verified: Oct 2026
First submitted: 16 Mar 2023
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

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.
PubMed 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.
PubMed 36523440

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
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Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
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All Acute Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Ischemic Post-conditioning in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
ClinicalTrials.gov ID: NCT05789823
Acronym / sponsor ID: PROTECT-2
Conditions: Acute Ischemic Stroke
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Capital Medical UniversityUniversity, hospital or other
Study start: 1 Nov 2023 (actual)
Primary completion: 16 May 2026 (actual)
Study completion: 16 Aug 2026 (actual)
First posted: 29 Mar 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ischemic post-conditioning group	Experimental	Procedure: Mechanical thrombectomy combined with ischemic post-conditioningMechanical thrombectomy combined with ischemic post-conditioning
Control group	Sham comparator	Procedure: Mechanical thrombectomy aloneMechanical thrombectomy alone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (7 listed)

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;

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
Mechanical thrombectomy combined with ischemic post-conditioningIschemic 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 or surgery	Ischemic post-conditioning group
Mechanical thrombectomy aloneSuccessful recanalization was achieved by mechanical thrombectomy without subsequent ischemic post-conditioning.	Procedure or surgery	Control group

Primary outcome

Infarct volume at 24 hours
Time frame: 24 hours after randomization
Infarct volume on MRI-DWI at 24 hours after randomization

12 secondary outcomes

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

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 21 Oct 2026.
Background: PubMed 37497674Wu 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.
Background: PubMed 36523440Wu 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Acute Ischemic Stroke

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
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Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
Not yet recruiting
Prehospital Response and Emergency Stroke Transport Optimisation
Acute Ischemic Stroke
RecruitingPhase 2
A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
Acute Ischemic Stroke
Active, not recruiting
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 7 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. Some participants in this study may receive a placebo. 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 at 24 hours (time frame: 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 NCT05789823, 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 21 Oct 2026.