Acute Ischemic StrokeANGEL-DRUGNCT07026318
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke
A study testing Tirofiban in people with Acute Ischemic Stroke, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Tirofiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 716 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 1 Apr 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Pre-stroke modified Rankin Scale (mRS) score of 0-1
- Acute ischemic stroke symptoms present within 24 hours of last known well time
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6
- Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6
- Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery
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- Clinical care team plans to perform endovascular thrombectomy (EVT)
- Subject or legally authorized representative can provide informed consent
- Residual stenosis ≥50% without planned angioplasty/stenting
Who cannot join
- Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT
- Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days
- Bleeding diathesis including coagulopathy (platelets <100×10⁹/L, aPTT >50s, or INR >2.0), DOAC use within 48 hours, or history of HIT
- Pregnancy or lactation at admission
- Contraindications to radiographic contrast agents, nickel, titanium or their alloys
- Life expectancy <6 months
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- Pre-existing neurological/psychiatric conditions that may confound assessment
- Severe renal insufficiency (GFR <30mL/min or Scr >220μmol/L [2.5mg/dL])
- Arterial tortuosity or anomalies preventing device delivery
- Unlikely to complete 90-day follow-up
- Any confirmed cardioembolic source (including atrial fibrillation, valvular disease, intracardiac thrombus, recent MI, cardiomyopathy with EF <30%, etc.)
- Tirofiban or other GP IIb/IIIa inhibitor use before randomization or other GP IIb/IIIa inhibitor used post treatment
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, 1 recruiting
- Recruiting
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 101118
About this study
Official title: Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial
This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tirofiban, Placebo
- Keywords
- Acute Ischemic Stroke, Tirofiban, placebo, Randomized Controlled Trial, Intracranial Atherosclerotic
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
After endovascular treatment, tirofiban is infused at a rate of 0.4 μg/kg/min for 30 minutes, followed by a maintenance infusion at 0.1 μg/kg/min until 24 hours postoperatively.
PlaceboDrug
Following endovascular treatment, patients receive normal saline placebo, with the dosage calculated in the same manner as that of tirofiban in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban group | Experimental | Receive Tirofiban treatment following endovascular therapy Receives: Drug: Tirofiban |
| placebo group | Placebo comparator | Receive placebo treatment after endovascular therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with mRS 0-2
Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
Measured: 90±7 days
Secondary outcomes (12)
Change in NIHSS score from baseline
Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function
Measured: 36±12 hours post-randomization
Vascular recanalization rate assessed by CT/MR angiography
Vascular recanalization rate assessed by CT/MR angiography
Measured: 36±12 hours post-randomization
Change in infarct volume
Change in infarct volume
Measured: 7±3 days post-randomization or discharge
Distribution of mRS scores
Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
Measured: 7±3 days/discharge；90±7 days post-randomization
Proportion of patients achieving mRS 0-1
Proportion of patients achieving mRS 0-1
Measured: 90±7 days
Proportion of patients achieving mRS 0-3
Proportion of patients achieving mRS 0-3
Measured: 90±7 days
Incidence of Pharmacologic rescue therapy
Incidence of Pharmacologic rescue therapy
Measured: 90±7 days
Incidence of rescue therapy
Incidence of rescue therapy
Measured: 90±7 days
EQ-5D-5L utility score
The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status.
Measured: 90±7 days
Probability of symptomatic intracranial hemorrhage
Probability of symptomatic intracranial hemorrhage (Heidelberg Standards)
Measured: 48 hours
All-cause mortality
All-cause mortality
Measured: 90±7 days post-randomization
Probability of any intracranial hemorrhage
Probability of any intracranial hemorrhage (Heidelberg Standards)
Measured: 48 hours post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start15 Aug 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 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 Beijing Anzhen HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026318
- Sponsor's protocol ID
- ANGEL-DRUG
- Acronym
- ANGEL-DRUG
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2025
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07026318
- Acronym / sponsor ID
- ANGEL-DRUG / ANGEL-DRUG
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Tirofiban, placebo, Randomized Controlled Trial, Intracranial Atherosclerotic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 716 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 18 Jun 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 randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.
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 |
|---|---|---|
| Tirofiban group | Experimental | Drug: TirofibanReceive Tirofiban treatment following endovascular therapy |
| placebo group | Placebo comparator | Drug: PlaceboReceive placebo treatment after endovascular therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Pre-stroke modified Rankin Scale (mRS) score of 0-1
- Acute ischemic stroke symptoms present within 24 hours of last known well time
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6
- Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6
Key exclusion criteria (12 listed)
- Intracranial hemorrhage confirmed by imaging prior to randomization, or major intracranial hemorrhage on intraprocedural flat-panel CT
- Gastrointestinal or genitourinary bleeding within 30 days post-stroke onset, or major surgery within 14 days
- Bleeding diathesis including coagulopathy (platelets <100×10⁹/L, aPTT >50s, or INR >2.0), DOAC use within 48 hours, or history of HIT
- Pregnancy or lactation at admission
- Contraindications to radiographic contrast agents, nickel, titanium or their alloys
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 |
|---|---|---|
| TirofibanAfter endovascular treatment, tirofiban is infused at a rate of 0.4 μg/kg/min for 30 minutes, followed by a maintenance infusion at 0.1 μg/kg/min until 24 hours postoperatively. | Drug | Tirofiban group |
| PlaceboFollowing endovascular treatment, patients receive normal saline placebo, with the dosage calculated in the same manner as that of tirofiban in the experimental group. | Drug | placebo group |
Primary outcome
Proportion of patients with mRS 0-2
Time frame: 90±7 days
Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale（0-6）, A lower MRS score indicates better functional status for the patient.
12 secondary outcomes
Change in NIHSS score from baseline
Time frame: 36±12 hours post-randomization
Vascular recanalization rate assessed by CT/MR angiography
Time frame: 36±12 hours post-randomization
Change in infarct volume
Time frame: 7±3 days post-randomization or discharge
Distribution of mRS scores
Time frame: 7±3 days/discharge；90±7 days post-randomization
Proportion of patients achieving mRS 0-1
Time frame: 90±7 days
Proportion of patients achieving mRS 0-3
Time frame: 90±7 days
Incidence of Pharmacologic rescue therapy
Time frame: 90±7 days
Incidence of rescue therapy
Time frame: 90±7 days
EQ-5D-5L utility score
Time frame: 90±7 days
Probability of symptomatic intracranial hemorrhage
Time frame: 48 hours
All-cause mortality
Time frame: 90±7 days post-randomization
Probability of any intracranial hemorrhage
Time frame: 48 hours post-randomization
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 22 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tirofiban in people with Acute Ischemic Stroke, run by Beijing Anzhen Hospital 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 9 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. 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. 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.
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 Xiaochuan Huo, Doctor (+86 13716292262, hxc810909@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with mRS 0-2 (time frame: 90±7 days). 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 22 Sep 2025.