ClinicalTrials.gg
RecruitingNCT07800572Updated Oct 13, 2026

Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL-2)

A Phase 2 interventional study of Anisodine Hydrobromide and Anisodine Hydrobromide Placebo in Acute Ischemic Stroke, sponsored by Capital Medical University. Recruiting at 13 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Capital Medical University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 13, 2026Site recruiting status changed2 sites addedGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 45 studies in Ischemic Stroke by Capital Medical University — 20 open to participants now, 25 under way, 10 of them phase 3. Ischemic Stroke · Capital Medical University.

Planned enrollment
21st of 39
204 · median 208
Started
2026
with 9 others
Phase 2
7 of 45
2 open now
Primary completion
2026-12
later than 11 of 24 live
Registered
45th of 45
by date

Among the 45 studies in Ischemic Stroke by Capital Medical University, this one is the 21st largest by planned enrollment of the 39 interventional ones that give a count, is one of 10 that started in 2026, is one of 7 in phase 2, reaches primary completion later than 11 of the 24 other live ones, and was the 45th registered.

Ischemic Stroke

2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

20 of the 45 studies in Ischemic Stroke by Capital Medical University are open now, in 1 country. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 20 open studies →

Where they have run

Who these studies take

Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 45 studies in Ischemic Stroke by Capital Medical University, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Acute Ischemic Stroke

Keywords

  • Endovascular Treatment
  • Neuroprotection
  • Stroke
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 provided by the participant or legally authorized representative

Exclusion criteria

Exclusion Criteria:

  • Intracranial hemorrhage on baseline imaging
  • Significant bleeding disorder or coagulopathy
  • Vascular anatomy unsuitable for EVT
  • Pregnancy, breastfeeding, or planned pregnancy within 90 days
  • Known or severe intolerance to anisodine hydrobromide
  • to anticholinergic drugs
  • Severe arrhythmia or hemodynamic instability
  • Severe psychiatric disorder, dementia, or impaired consciousness precluding consent or follow-up
  • or other severe systemic disease with a \<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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
204 participants (estimated)

Study arms

  • Experimental
    Anisodine Hydrobromide Group

    Participants will receive anisodine hydrobromide combined with endovascular thrombectomy.

    Drug: Anisodine Hydrobromide

  • Placebo comparator
    Anisodine Hydrobromide placebo

    Participants will receive placebo combined with endovascular thrombectomy.

    Drug: Anisodine Hydrobromide Placebo

Interventions

  • 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.

  • DrugAnisodine Hydrobromide Placebo

    An equivalent volume of 0.9% sodium chloride solution, administered by intravenous infusion twice daily for a total of 14 doses.

06

What researchers measure

Primary outcomes

  1. Cerebral Infarct Volume on Day 8

    Time frame: Day 8

Secondary outcomes

  1. NIHSS Score at 24 Hours

    Time frame: 24 hours

  2. NIHSS Score on Day 8

    The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment and a worse outcome.

    Time frame: Day 8

  3. 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.

    Time frame: Baseline to Day 8

  4. mRS Score of 0-1 at 90 Days

    The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.

    Time frame: 90 Days

  5. mRS Score of 0-2 at 90 Days

    The mRS ranges from 0 to 6, with higher scores indicating greater disability or death

    Time frame: 90 Days

  6. Distribution of mRS scores at 90 Days

    The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.

    Time frame: 90 Days

  7. 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.

    Time frame: 90 Days

  8. 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.

    Time frame: 90 Days

Other outcomes

  1. Neurological Deterioration Within 24 Hours

    an increase of ≥4 points in the NIHSS score from baseline

    Time frame: Within 24 hours

  2. Symptomatic Intracranial Hemorrhage Within 8 Days

    Time frame: Within 8 Days

  3. All Cause Mortality at 90 Days

    Time frame: Within 90 days

  4. Intracranial Hemorrhage Within 8 Days

    Time frame: Within 8 Days

07

Study locations

12 of 13 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.

Of 83 non-industry phase 2 interventional studies under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 3 months is below that.

Counting every sponsor, half of 124 studies reached it within 28 months; a quarter within 15 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2026
First posted
Sep 2, 2026
StartActual
Sep 6, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Mar 31, 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added. Lishui Central Hospital is now Recruiting
Show 2 added (2 China)
  • Yueqing People's Hospital · Yueqing, China
  • Yulin Second People's Hospital · Yulin, China
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    2 sites added. Lishui Central Hospital is now Recruiting
    Show 2 added (2 China)
    • Yueqing People's Hospital · Yueqing, China
    • Yulin Second People's Hospital · Yulin, China

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07800572
Responsible party
Ji Xunming,MD,PhD (Professor of Neurology, Xuanwu Hospital, Capital Medical University, Capital Medical University) — Principal investigator
First posted
Sep 2, 2026
Start date
Sep 6, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Xunming Ji, PhD/MD
Contact
jixm@ccmu.edu.cn
01083198962
Chuanjie Wu, PhD/MD
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Anisodine

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