Acute Ischemic StrokePhase 2NCT07800572
Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL-2)
A Phase 2 study testing Anisodine Hydrobromide in people with Acute Ischemic Stroke, run by Capital Medical University at 13 sites in China.
Trial summary
This phase 2, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of anisodine hydrobromide in patients with acute ischemic stroke undergoing endovascular thrombectomy. 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?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 13 sitesChina
- Study dates
- 6 Sep 2026to 31 Mar 2027
- Phase
- Phase 2
- 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 18-80 years
- Anterior-circulation large-vessel occlusion involving the intracranial ICA, M1, or proximal/dominant M2
- Eligible for endovascular treatment within 24 hours of last known well
- Baseline NIHSS score ≥6
- Baseline ASPECTS ≥6
- Pre-stroke mRS score 0-1
- Written informed consent provided by the participant or legally authorized representative
Who cannot join
- Intracranial hemorrhage on baseline imaging
- Significant bleeding disorder or coagulopathy
- Vascular anatomy unsuitable for EVT
- Pregnancy, breastfeeding, or planned pregnancy within 90 days
- Known hypersensitivity or severe intolerance to anisodine hydrobromide
- Contraindication to anticholinergic drugs
Show all 11Show fewer
- Severe arrhythmia or hemodynamic instability
- Severe psychiatric disorder, dementia, or impaired consciousness precluding consent or follow-up
- Malignancy or other severe systemic disease with a life expectancy <90 days
- Participation in another clinical trial within 30 days before enrollment or concurrently
- Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chuanjie Wu, PhD/MD contact
13 sites in 1 country
China13 sites, 13 recruiting
- Not yet recruiting
Anyang People's Hospital
Anyang
- Recruiting
Xuanwu Hospital，Capital Medical University
Beijing
- Recruiting
Anji County People's Hospital
Huzhou
- Recruiting
Jiuquan People's Hospital
Jiuquan
- Recruiting
Lishui Central Hospital
Lishui
- Recruiting
Shangqiu First People's Hospitl
Shangqiu
- Recruiting
Suzhou Municipal Hospital of Anhui Province
Suzhou
- Recruiting
Taizhou Enze Medical Center (Group) Enze Hospital
Taizhou
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
- Recruiting
Yueqing People's Hospital
Yueqing
Saizhen Wu
- Recruiting
Yulin Second People's Hospital
Yulin
Sheng Yang
- Recruiting
Zhangpu County Hospital
Zhangzhou
- Recruiting
Zibo Central Hospital
Zibo
About this study
Official title: Efficacy and Safety of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment
This phase 2, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of anisodine hydrobromide in patients with acute ischemic stroke undergoing endovascular thrombectomy.
Read the detailed description
Eligible participants will be randomly assigned to receive anisodine hydrobromide or matching placebo in addition to standard care, with efficacy and safety assessed during follow-up.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Anisodine Hydrobromide, Anisodine Hydrobromide Placebo
- 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, 2 mg per dose, diluted in 0.9% sodium chloride solution and administered by intravenous infusion twice daily for a total of 14 doses.
Anisodine Hydrobromide PlaceboDrug
An equivalent volume of 0.9% sodium chloride solution, administered by intravenous infusion twice daily for a total of 14 doses.
| Study group | Role | What they receive |
|---|---|---|
| Anisodine Hydrobromide Group | Experimental | Participants will receive anisodine hydrobromide combined with endovascular thrombectomy. Receives: Drug: Anisodine Hydrobromide |
| Anisodine Hydrobromide placebo | Placebo comparator | Participants will receive placebo combined with endovascular thrombectomy. Receives: Drug: Anisodine Hydrobromide Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Infarct Volume on Day 8
Measured: Day 8
Secondary outcomes (8)
NIHSS Score at 24 Hours
Measured: 24 hours
NIHSS Score on Day 8
The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment and a worse outcome.
Measured: Day 8
Change in NIHSS Score From Baseline to Day 8
The NIHSS ranges from 0 to 42. Change is calculated as the Day 8 score minus the baseline score.
Measured: Baseline to Day 8
mRS Score of 0-1 at 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Measured: 90 Days
mRS Score of 0-2 at 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death
Measured: 90 Days
Distribution of mRS scores at 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Measured: 90 Days
EQ-5D-5L at 90 Days
The EQ-5D-5L index score ranges from -0.391 to 1.000 using the Chinese value set, with higher scores indicating better health-related quality of life.
Measured: 90 Days
Barthel Index Score of 95-100 at 90 Days
The Barthel Index ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start6 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 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
- NCT07800572
- Sponsor's protocol ID
- HEAL-2
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment
- ClinicalTrials.gov ID
- NCT07800572
- Acronym / sponsor ID
- HEAL-2
- Conditions
- Acute Ischemic Stroke
- Keywords
- Endovascular Treatment, Neuroprotection, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 6 Sep 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Sep 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 phase 2, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of anisodine hydrobromide in patients with acute ischemic stroke undergoing endovascular thrombectomy.
Detailed description
Eligible participants will be randomly assigned to receive anisodine hydrobromide or matching placebo in addition to standard care, with efficacy and safety assessed during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anisodine Hydrobromide Group | Experimental | Drug: Anisodine HydrobromideParticipants will receive anisodine hydrobromide combined with endovascular thrombectomy. |
| Anisodine Hydrobromide placebo | Placebo comparator | Drug: Anisodine Hydrobromide PlaceboParticipants will receive placebo combined with endovascular thrombectomy. |
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 18-80 years
- Anterior-circulation large-vessel occlusion involving the intracranial ICA, M1, or proximal/dominant M2
- Eligible for endovascular treatment within 24 hours of last known well
- Baseline NIHSS score ≥6
- Baseline ASPECTS ≥6
Key exclusion criteria (11 listed)
- Intracranial hemorrhage on baseline imaging
- Significant bleeding disorder or coagulopathy
- Vascular anatomy unsuitable for EVT
- Pregnancy, breastfeeding, or planned pregnancy within 90 days
- Known hypersensitivity or severe intolerance to anisodine hydrobromide
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, 2 mg per dose, diluted in 0.9% sodium chloride solution and administered by intravenous infusion twice daily for a total of 14 doses. | Drug | Anisodine Hydrobromide Group |
| Anisodine Hydrobromide PlaceboAn equivalent volume of 0.9% sodium chloride solution, administered by intravenous infusion twice daily for a total of 14 doses. | Drug | Anisodine Hydrobromide placebo |
Primary outcome
Cerebral Infarct Volume on Day 8
Time frame: Day 8
8 secondary outcomes
NIHSS Score at 24 Hours
Time frame: 24 hours
NIHSS Score on Day 8
Time frame: Day 8
Change in NIHSS Score From Baseline to Day 8
Time frame: Baseline to Day 8
mRS Score of 0-1 at 90 Days
Time frame: 90 Days
mRS Score of 0-2 at 90 Days
Time frame: 90 Days
Distribution of mRS scores at 90 Days
Time frame: 90 Days
EQ-5D-5L at 90 Days
Time frame: 90 Days
Barthel Index Score of 95-100 at 90 Days
Time frame: 90 Days
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Chuanjie Wu, PhD/MD contact
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anisodine Hydrobromide in people with Acute Ischemic Stroke, run by Capital Medical University at 13 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 11 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: looking for participants now, as of the sponsor's last update on 13 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 13 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?
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?
Contact Xunming Ji, PhD/MD (01083198962, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Infarct Volume on Day 8 (time frame: Day 8). 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 13 Oct 2026.