Acute Ischemic StrokePhase 1HEALNCT07513233
Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL)
A Phase 1 study testing Anisodine Hydrobromide in people with Acute Ischemic Stroke, run by Capital Medical University at 10 sites in China.
Trial summary
This study is an investigator-initiated Phase 1b clinical trial employing an open-label, non-randomized, dose-escalation design. The primary objective is to evaluate the safety and tolerability of the investigational intervention and to determine the recommended dose for subsequent clinical studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Anisodine Hydrobromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 10 sitesChina
- Study dates
- 28 Apr 2026to 20 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years.
- Imaging-confirmed anterior-circulation large-vessel occlusion involving the intracranial internal carotid artery, the middle cerebral artery M1 segment, or the proximal M2 segment or a dominant M2 branch. A dominant M2 branch was defined as an M2 branch supplying ≥50% of the middle cerebral artery territory.
- Eligible for and planned to undergo endovascular treatment (EVT) within 24 hours according to current clinical practice.
- National Institutes of Health Stroke Scale (NIHSS) score ≥6 at baseline.
- Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline noncontrast CT.
- Pre-stroke modified Rankin Scale (mRS) score of 0 to 1.
- Provision of written informed consent by the participant or the participant's legally authorized representative.
Who cannot join
- Evidence of intracranial hemorrhagic disease on head CT, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage.
- History of congenital or acquired bleeding disorders, coagulation factor deficiency, thrombocytopenic disorders, or other clinically significant hemorrhagic conditions.
- Vascular anatomy expected to preclude successful endovascular treatment because of excessive tortuosity or other technical reasons.
- Known allergy to iodinated contrast agents.
- Pregnant or breastfeeding women, or women planning pregnancy during the study period or within 90 days after enrollment.
- Known hypersensitivity to anisodine hydrobromide or a history of severe intolerance after prior exposure.
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- Presence of clinical conditions that may be worsened by anticholinergic drugs, including but not limited to angle-closure glaucoma, urinary retention or benign prostatic hyperplasia with dysuria, or paralytic ileus.
- Severe arrhythmia or hemodynamic instability, including but not limited to tachyarrhythmia requiring cardioversion, recurrent syncope due to arrhythmia, vasopressor-dependent hypotension, or persistent hypotension.
- Severe psychiatric disorder, dementia, or impaired consciousness that would preclude informed consent or protocol-required follow-up.
- Malignant tumor or other severe systemic disease with an expected survival of less than 90 days.
- Participation in another interventional clinical study within 30 days before enrollment, or current participation in another interventional clinical study.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Xuanwu Hospital, Capital Medical University
Beijing, None Selected, 100053
Anji County People's Hospital
Huzhou, Zhejiang, 313300
Jiuquan City People's Hospital
Jiuquan, Gansu, 735000
The First People's Hospital of Shangqiu
Shangqiu, Henan, 476100
Taizhou Enze Medical Center (Group) Enze Hospital
Taizhou, Zhejiang, 318053
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Yueqing People's Hospital
Yueqing, Zhejiang, 325600
The Second People's Hospital of Yulin
Yulin, Guangxi, 537000
Zhangpu County Hospital
Zhangzhou, Fujian, 363200
Zibo Central Hospital
Zibo, Shandong, 255036
About this study
Official title: Safety and Efficacy of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment
This study is an investigator-initiated Phase 1b clinical trial employing an open-label, non-randomized, dose-escalation design. The primary objective is to evaluate the safety and tolerability of the investigational intervention and to determine the recommended dose for subsequent clinical studies.
Read the detailed description
This study is an investigator-initiated, prospective, multicenter Phase Ib clinical trial designed to evaluate the safety, tolerability, and dose feasibility of anisodine hydrobromide administered in patients with acute ischemic stroke undergoing endovascular therapy. The trial adopts an open-label, non-randomized, dose-escalation design to identify the maximum tolerated dose (MTD) and to determine the recommended Phase II dose (RP2D).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Anisodine Hydrobromide
- Keywords
- Endovascular Treatment, Neuroprotection, Stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anisodine HydrobromideDrug
Anisodine hydrobromide injection is administered intravenously in addition to standard endovascular therapy for acute ischemic stroke. The investigational drug is diluted in 250 mL of 0.9% sodium chloride solution and infused over approximately 60 minutes. Treatment is given twice daily (BID) for 7 consecutive days, with the first dose initiated prior to vascular recanalization.
In this Phase Ib study, four dose levels (1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg per dose) are evaluated using a sequential, cohort-based dose-escalation design to assess safety, tolerability, and dose feasibility. All participants receive standard-of-care endovascular therapy according to current clinical guidelines, including mechanical thrombectomy and/or adjunctive procedures as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Anisodine Hydrobromide 1.0 mg | Experimental | Participants receive anisodine hydrobromide 1.0 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes. Receives: Drug: Anisodine Hydrobromide |
| Anisodine Hydrobromide 1.5 mg | Experimental | Participants receive anisodine hydrobromide 1.5 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes. Receives: Drug: Anisodine Hydrobromide |
| Anisodine Hydrobromide 2.0 mg | Experimental | Participants receive anisodine hydrobromide 2.0 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes. Receives: Drug: Anisodine Hydrobromide |
| Anisodine Hydrobromide 2.5 mg | Experimental | Participants receive anisodine hydrobromide 2.5 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes. Receives: Drug: Anisodine Hydrobromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Predefined Safety Events
The primary safety outcome is the incidence of prespecified safety events occurring within 8 days after the first administration of the study drug. Prespecified safety events include: (1) symptomatic intracranial hemorrhage, defined as any intracranial hemorrhage confirmed on neuroimaging in conjunction with neurological deterioration, operationalized as an increase of at least 4 points in the NIHSS score; (2) death from any cause; and (3) any other serious adverse event, excluding the foregoing events, that is adjudicated by the Data Monitoring Committee (DMC) to be definitely, probably, or possibly related to the study drug.
Measured: Within 8 days after the first administration
Secondary outcomes (6)
Early Neurological Deterioration
Early neurological deterioration is defined as a worsening in neurological status within 24 hours after the initiation of treatment. Neurological status is quantified using the National Institutes of Health Stroke Scale (NIHSS), a validated clinical instrument for assessing stroke severity. The total score of the NIHSS ranges from a minimum of 0 to a maximum of 42. On this scale, higher scores indicate greater neurological impairment and a worse clinical outcome, whereas a score of 0 represents the absence of detectable neurological deficits.
Measured: Within 24 hours after treatment initiation
Infarct Volume
Infarct volume measured on cranial computed tomography (CT) at Day 8, expressed in milliliters (mL).
Measured: Day 8
Functional Outcome (Modified Rankin Scale)
Functional outcome assessed using the modified Rankin Scale (mRS), reported as the distribution of scores ranging from 0 (no symptoms) to 6 (death).
Measured: Day 90
Symptomatic Intracranial Hemorrhage
Incidence of symptomatic intracranial hemorrhage confirmed by imaging and associated with neurological deterioration (increase of ≥4 points in NIHSS).
Measured: Within 8 days after the first administration
Intracranial Hemorrhage
Incidence of any intracranial hemorrhage detected by imaging within 8 days after the first administration.
Measured: Within 8 days after the first administration
All-cause Mortality
All-cause mortality occurring within 90 days after the first administration of the investigational drug.
Measured: Within 90 days after the first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start28 Apr 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513233
- Sponsor's protocol ID
- HEAL
- Acronym
- HEAL
- Status last verified
- Aug 2026
- First submitted
- 29 Mar 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment
- ClinicalTrials.gov ID
- NCT07513233
- Acronym / sponsor ID
- HEAL / HEAL
- Conditions
- Acute Ischemic Stroke
- Keywords
- Endovascular Treatment, Neuroprotection, Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 7 Apr 2026 (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.
This study is an investigator-initiated Phase 1b clinical trial employing an open-label, non-randomized, dose-escalation design. The primary objective is to evaluate the safety and tolerability of the investigational intervention and to determine the recommended dose for subsequent clinical studies.
Detailed description
This study is an investigator-initiated, prospective, multicenter Phase Ib clinical trial designed to evaluate the safety, tolerability, and dose feasibility of anisodine hydrobromide administered in patients with acute ischemic stroke undergoing endovascular therapy. The trial adopts an open-label, non-randomized, dose-escalation design to identify the maximum tolerated dose (MTD) and to determine the recommended Phase II dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anisodine Hydrobromide 1.0 mg | Experimental | Drug: Anisodine HydrobromideParticipants receive anisodine hydrobromide 1.0 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes. |
| Anisodine Hydrobromide 1.5 mg | Experimental | Drug: Anisodine HydrobromideParticipants receive anisodine hydrobromide 1.5 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes. |
| Anisodine Hydrobromide 2.0 mg | Experimental | Drug: Anisodine HydrobromideParticipants receive anisodine hydrobromide 2.0 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes. |
| Anisodine Hydrobromide 2.5 mg | Experimental | Drug: Anisodine HydrobromideParticipants receive anisodine hydrobromide 2.5 mg per dose intravenously twice daily for 7 consecutive days in addition to standard endovascular therapy. The first dose is initiated before vascular recanalization; however, administration of the study drug must not delay EVT or other standard endovascular procedures. The study drug is diluted in 0.9% sodium chloride solution and infused over approximately 60 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years.
- Imaging-confirmed anterior-circulation large-vessel occlusion involving the intracranial internal carotid artery, the middle cerebral artery M1 segment, or the proximal M2 segment or a dominant M2 branch. A dominant M2 branch was defined as an M2 branch supplying ≥50% of the middle cerebral artery territory.
- Eligible for and planned to undergo endovascular treatment (EVT) within 24 hours according to current clinical practice.
- National Institutes of Health Stroke Scale (NIHSS) score ≥6 at baseline.
- Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline noncontrast CT.
Key exclusion criteria (12 listed)
- Evidence of intracranial hemorrhagic disease on head CT, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage.
- History of congenital or acquired bleeding disorders, coagulation factor deficiency, thrombocytopenic disorders, or other clinically significant hemorrhagic conditions.
- Vascular anatomy expected to preclude successful endovascular treatment because of excessive tortuosity or other technical reasons.
- Known allergy to iodinated contrast agents.
- Pregnant or breastfeeding women, or women planning pregnancy during the study period or within 90 days after enrollment.
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 |
|---|---|---|
| Anisodine HydrobromideAnisodine hydrobromide injection is administered intravenously in addition to standard endovascular therapy for acute ischemic stroke. The investigational drug is diluted in 250 mL of 0.9% sodium chloride solution and infused over approximately 60 minutes. Treatment is given twice daily (BID) for 7 consecutive days, with the first dose initiated prior to vascular recanalization. In this Phase Ib study, four dose levels (1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg per dose) are evaluated using a sequential, cohort-based dose-escalation design to assess safety, tolerability, and dose feasibility. All participants receive standard-of-care endovascular therapy according to current clinical guidelines, including mechanical thrombectomy and/or adjunctive procedures as clinically indicated. | Drug | Anisodine Hydrobromide 1.0 mg, Anisodine Hydrobromide 1.5 mg, Anisodine Hydrobromide 2.0 mg, Anisodine Hydrobromide 2.5 mg |
Primary outcome
Incidence of Predefined Safety Events
Time frame: Within 8 days after the first administration
The primary safety outcome is the incidence of prespecified safety events occurring within 8 days after the first administration of the study drug. Prespecified safety events include: (1) symptomatic intracranial hemorrhage, defined as any intracranial hemorrhage confirmed on neuroimaging in conjunction with neurological deterioration, operationalized as an increase of at least 4 points in the NIHSS score; (2) death from any cause; and (3) any other serious adverse event, excluding the foregoing events, that is adjudicated by the Data Monitoring Committee (DMC) to be definitely, probably, or possibly related to the study drug.
6 secondary outcomes
Early Neurological Deterioration
Time frame: Within 24 hours after treatment initiation
Infarct Volume
Time frame: Day 8
Functional Outcome (Modified Rankin Scale)
Time frame: Day 90
Symptomatic Intracranial Hemorrhage
Time frame: Within 8 days after the first administration
Intracranial Hemorrhage
Time frame: Within 8 days after the first administration
All-cause Mortality
Time frame: Within 90 days after the first administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anisodine Hydrobromide in people with Acute Ischemic Stroke, run by Capital Medical University at 10 sites 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 7 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Predefined Safety Events (time frame: Within 8 days after the first administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.