Ischemic Stroke, AcutePhase 4PRECISE AMNCT07091994
A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
A Phase 4 study testing edaravone dexborneol injection and Standard therapeutic protocol in people with Ischemic Stroke, Acute and Active Malignancies, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute, Active Malignancies
- What is being tested?
- edaravone dexborneol injection and Standard therapeutic protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2026
- Phase
- Phase 4
- 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 between 18 and 80 years (inclusive);
- Diagnosis of acute ischemic stroke (AIS) according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke;
- Time from symptom onset to enrollment ≤48 hours;
- Presence of focal neurological deficits with a baseline NIHSS score of 4-24, and a combined score of ≥2 points on NIHSS Item 5 (upper limb motor) and Item 6 (lower limb motor);
- Confirmed active malignancy before stroke onset or during hospitalization, defined as: Cancer diagnosed within 12 months prior to stroke, Presence of metastatic disease, Received cancer-directed therapy within the past 30 days, or Patients who declined cancer treatment (still considered active malignancy);
- Signed informed consent obtained from the patient or legally authorized representative.
Who cannot join
- Intracranial hemorrhagic diseases detected on head CT: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
- Pre-stroke modified Rankin Scale (mRS) score >1;
- Transient ischemic attack (TIA) as the current event;
- Non-invasive skin cancers (e.g., basal cell carcinoma), primary central nervous system tumors, or hematologic malignancies;
- Use of neuroprotective agents, including but not limited to: marketed edaravone, nimodipine, gangliosides, citicoline, piracetam, butylphthalide, human urinary kallidinogenase, or certain Chinese herbal medicines (see Concomitant Medications for details);
- Patients with severe psychiatric disorders or dementia;
Show all 13Show fewer
- Hepatic or renal dysfunction: ALT or AST >3× upper limit of normal (ULN); Known liver diseases (e.g., acute/chronic active hepatitis, cirrhosis); Known kidney disease, renal insufficiency, serum creatinine >1.5×ULN, or creatinine clearance <50 mL/min;
- Severe systemic diseases with an expected survival <90 days;
- Pre-stroke Eastern Cooperative Oncology Group (ECOG) performance status ≥3;
- Hypersensitivity to edaravone, (+)-borneol, or any excipients;
- Pregnancy, lactation, or planned pregnancy;
- Participation in another clinical trial within 30 days prior to randomization or current enrollment in other interventional studies;
- Any other condition deemed inappropriate for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Baiyun, 510515
Jia Yin, M.D, +8613802964883, jiajiayin@139.com
Weike Hu, M.D, +8618326349212, weike946@gmail.com
About this study
Official title: A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
This multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. The study will primarily investigate whether this combined antioxidant and anti-inflammatory treatment can improve neurological functional recovery and assess its safety profile in this high-risk population. Investigators will compare outcomes between the edaravone dexborneol treatment group and a control group receiving standard therapy to determine if the intervention provides superior neuroprotective effects. Participants will receive the assigned treatment regimen, undergo serial neurological assessments and imaging studies to monitor stroke progression and recovery, and be closely followed for safety evaluations. The findings may offer evidence-based therapeutic options for managing this challenging clinical scenario where current treatment alternatives are limited.
Read the detailed description
Patients with acute ischemic stroke (AIS) who also have active malignancies face a more complex clinical scenario, with limited treatment options and generally poor prognoses. The coexistence of these two conditions can interact through inflammatory and oxidative stress pathways, forming a vicious cycle that exacerbates the patient's condition. Edaravone dexborneol injection exhibits significant antioxidant and anti-inflammatory effects, effectively scavenging free radicals in the body, thereby potentially improving the outcomes of AIS patients. Preliminary retrospective study demonstrated that edaravone dexborneol injection can promote neurological recovery in AIS patients with active malignancies and shows a favorable safety profile. Therefore, this study aims to conduct a multicenter randomized controlled trial to evaluate the efficacy and safety of edaravone dexborneol injection in treating AIS patients with active malignancies, with the goal of providing evidence-based medical support and more effective therapeutic strategies for this specific patient population.
- Conditions
- Ischemic Stroke, Acute, Active Malignancies
- Being tested
- edaravone dexborneol injection, Standard therapeutic protocol
- Keywords
- active malignancies, ischemic stroke, acute, edaravone dexborneol, neuroprotection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edaravone dexborneol injectionDrug
The experimental intervention involved twice-daily administration of edaravone dexborneol injection at a dose of 37.5 mg (containing 30 mg edaravone and 7.5 mg dexborneol), with doses spaced exactly 12 hours apart. For each infusion, the study medication was first diluted in 100 mL of normal saline (0.9% sodium chloride solution) and then administered as a controlled intravenous infusion over a precisely timed 30-minute period. This standardized dosing regimen was maintained consistently throughout the 10-14 day treatment course for all participants in the experimental group.
Standard therapeutic protocolDrug
The standard treatment regimen, which may include antiplatelet therapy, anticoagulation (if indicated), blood pressure management, and other evidence-based interventions, will be administered continuously for 10 to 14 days according to current clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Subjects randomized to the trial group will receive edaravone dexborneol injection at a dose of 37.5 mg (consisting of 30 mg edaravone and 7.5 mg dexborneol) administered twice daily with a fixed 12-hour interval between doses. The study drug will be diluted in 100 mL of normal saline and delivered via intravenous infusion over 30 minutes. This treatment regimen will be maintained for a duration of 10 to 14 days, in addition to standard stroke care. Strict adherence to the dosing schedule and infusion protocol will be ensured to maintain treatment consistency across study sites. Receives: Drug: edaravone dexborneol injection; Drug: Standard therapeutic protocol |
| Control group | Active comparator | Subjects randomized to the control group will receive conventional standard therapy for acute ischemic stroke without the addition of edaravone dexborneol. The standard treatment regimen, which may include antiplatelet therapy, anticoagulation (if indicated), blood pressure management, and other evidence-based interventions, will be administered continuously for 10 to 14 days according to current clinical guidelines. All patients in this group will receive the same intensity of monitoring and follow-up as the experimental group to ensure comparable assessment of outcomes. Receives: Drug: Standard therapeutic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NIHSS score from baseline to Day 30 post-treatment.
Measured: From enrollment to the end of treatment at Day 30
Secondary outcomes (12)
mRS score
Measured: From enrollment to the end of treatment at Day 30 and Day 90
Proportion of patients with mRS score ≤2
Measured: From enrollment to the end of treatment at Day 30 and Day 90
Change in NIHSS score
Measured: From enrollment to the end of treatment at Day 14 and Day 90
Incidence of symptomatic intracranial hemorrhage transformation
Measured: From enrollment to the end of treatment at 36-48 hours and 7 days
Proportion of patients with Barthel Index (BI) score ≥95
Measured: From enrollment to the end of treatment at Day 14, Day 30, and Day 90
All-cause mortality rate
Measured: From enrollment to the end of treatment at Day 30 and Day 90
Changes in serum inflammatory markers and coagulation parameters
Measured: From enrollment to the end of treatment at Day 14 and Day 30
Overall incidence of adverse events (AEs)
Measured: From enrollment to the end of treatment at 90 days
Incidence of treatment-emergent adverse events (TEAEs)
Measured: From enrollment to the end of treatment at 90 days
Occurrence of significant adverse events
Measured: From enrollment to the end of treatment at 90 days
Incidence of serious adverse events (SAEs)
Measured: From enrollment to the end of treatment at 90 days
Abnormalities in clinical laboratory tests
Measured: From enrollment to the end of treatment at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This multicenter, randomized, open-label, controlled clinical trial will evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. Eligible participants will be randomly assigned to receive either standard therapy combined with edaravone dexborneol injection or standard therapy alone for a treatment period of 10-14 days, followed by a 90-day follow-up period with scheduled assessments. The study will compare neurological functional recovery and safety profiles between the two treatment arms.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091994
- Sponsor's protocol ID
- NFEC-2025-303
- Acronym
- PRECISE AM
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
- ClinicalTrials.gov ID
- NCT07091994
- Acronym / sponsor ID
- PRECISE AM / NFEC-2025-303
- Conditions
- Ischemic Stroke, Acute, Active Malignancies
- Keywords
- active malignancies, ischemic stroke, acute, edaravone dexborneol, neuroprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2025 (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 multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. The study will primarily investigate whether this combined antioxidant and anti-inflammatory treatment can improve neurological functional recovery and assess its safety profile in this high-risk population. Investigators will compare outcomes between the edaravone dexborneol treatment group and a control group receiving standard therapy to determine if the intervention provides superior neuroprotective effects. Participants will receive the assigned treatment regimen, undergo serial neurological assessments and imaging studies to monitor stroke progression and recovery, and be closely followed for safety evaluations. The findings may offer evidence-based therapeutic options for managing this challenging clinical scenario where current treatment alternatives are limited.
Detailed description
Patients with acute ischemic stroke (AIS) who also have active malignancies face a more complex clinical scenario, with limited treatment options and generally poor prognoses. The coexistence of these two conditions can interact through inflammatory and oxidative stress pathways, forming a vicious cycle that exacerbates the patient's condition. Edaravone dexborneol injection exhibits significant antioxidant and anti-inflammatory effects, effectively scavenging free radicals in the body, thereby potentially improving the outcomes of AIS patients. Preliminary retrospective study demonstrated that edaravone dexborneol injection can promote neurological recovery in AIS patients with active malignancies and shows a favorable safety profile. Therefore, this study aims to conduct a multicenter randomized controlled trial to evaluate the efficacy and safety of edaravone dexborneol injection in treating AIS patients with active malignancies, with the goal of providing evidence-based medical support and more effective therapeutic strategies for this specific patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This multicenter, randomized, open-label, controlled clinical trial will evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. Eligible participants will be randomly assigned to receive either standard therapy combined with edaravone dexborneol injection or standard therapy alone for a treatment period of 10-14 days, followed by a 90-day follow-up period with scheduled assessments. The study will compare neurological functional recovery and safety profiles between the two treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: edaravone dexborneol injection, Drug: Standard therapeutic protocolSubjects randomized to the trial group will receive edaravone dexborneol injection at a dose of 37.5 mg (consisting of 30 mg edaravone and 7.5 mg dexborneol) administered twice daily with a fixed 12-hour interval between doses. The study drug will be diluted in 100 mL of normal saline and delivered via intravenous infusion over 30 minutes. This treatment regimen will be maintained for a duration of 10 to 14 days, in addition to standard stroke care. Strict adherence to the dosing schedule and infusion protocol will be ensured to maintain treatment consistency across study sites. |
| Control group | Active comparator | Drug: Standard therapeutic protocolSubjects randomized to the control group will receive conventional standard therapy for acute ischemic stroke without the addition of edaravone dexborneol. The standard treatment regimen, which may include antiplatelet therapy, anticoagulation (if indicated), blood pressure management, and other evidence-based interventions, will be administered continuously for 10 to 14 days according to current clinical guidelines. All patients in this group will receive the same intensity of monitoring and follow-up as the experimental group to ensure comparable assessment of outcomes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 80 years (inclusive);
- Diagnosis of acute ischemic stroke (AIS) according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke;
- Time from symptom onset to enrollment ≤48 hours;
- Presence of focal neurological deficits with a baseline NIHSS score of 4-24, and a combined score of ≥2 points on NIHSS Item 5 (upper limb motor) and Item 6 (lower limb motor);
- Confirmed active malignancy before stroke onset or during hospitalization, defined as: Cancer diagnosed within 12 months prior to stroke, Presence of metastatic disease, Received cancer-directed therapy within the past 30 days, or Patients who declined cancer treatment (still considered active malignancy);
Key exclusion criteria (13 listed)
- Intracranial hemorrhagic diseases detected on head CT: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
- Pre-stroke modified Rankin Scale (mRS) score >1;
- Transient ischemic attack (TIA) as the current event;
- Non-invasive skin cancers (e.g., basal cell carcinoma), primary central nervous system tumors, or hematologic malignancies;
- Use of neuroprotective agents, including but not limited to: marketed edaravone, nimodipine, gangliosides, citicoline, piracetam, butylphthalide, human urinary kallidinogenase, or certain Chinese herbal medicines (see Concomitant Medications for details);
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 |
|---|---|---|
| edaravone dexborneol injectionThe experimental intervention involved twice-daily administration of edaravone dexborneol injection at a dose of 37.5 mg (containing 30 mg edaravone and 7.5 mg dexborneol), with doses spaced exactly 12 hours apart. For each infusion, the study medication was first diluted in 100 mL of normal saline (0.9% sodium chloride solution) and then administered as a controlled intravenous infusion over a precisely timed 30-minute period. This standardized dosing regimen was maintained consistently throughout the 10-14 day treatment course for all participants in the experimental group. | Drug | Intervention group |
| Standard therapeutic protocolThe standard treatment regimen, which may include antiplatelet therapy, anticoagulation (if indicated), blood pressure management, and other evidence-based interventions, will be administered continuously for 10 to 14 days according to current clinical guidelines. | Drug | Control group, Intervention group |
Primary outcome
Change in NIHSS score from baseline to Day 30 post-treatment.
Time frame: From enrollment to the end of treatment at Day 30
12 secondary outcomes
mRS score
Time frame: From enrollment to the end of treatment at Day 30 and Day 90
Proportion of patients with mRS score ≤2
Time frame: From enrollment to the end of treatment at Day 30 and Day 90
Change in NIHSS score
Time frame: From enrollment to the end of treatment at Day 14 and Day 90
Incidence of symptomatic intracranial hemorrhage transformation
Time frame: From enrollment to the end of treatment at 36-48 hours and 7 days
Proportion of patients with Barthel Index (BI) score ≥95
Time frame: From enrollment to the end of treatment at Day 14, Day 30, and Day 90
All-cause mortality rate
Time frame: From enrollment to the end of treatment at Day 30 and Day 90
Changes in serum inflammatory markers and coagulation parameters
Time frame: From enrollment to the end of treatment at Day 14 and Day 30
Overall incidence of adverse events (AEs)
Time frame: From enrollment to the end of treatment at 90 days
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From enrollment to the end of treatment at 90 days
Occurrence of significant adverse events
Time frame: From enrollment to the end of treatment at 90 days
Incidence of serious adverse events (SAEs)
Time frame: From enrollment to the end of treatment at 90 days
Abnormalities in clinical laboratory tests
Time frame: From enrollment to the end of treatment at 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 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing edaravone dexborneol injection and Standard therapeutic protocol in people with Ischemic Stroke, Acute and Active Malignancies, run by Nanfang Hospital, Southern Medical University 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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 16 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jia Yin, M.D (+8613802964883, jiajiayin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NIHSS score from baseline to Day 30 post-treatment. (time frame: From enrollment to the end of treatment at Day 30). 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 16 Apr 2026.