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Acute Ischemic StrokePhase 2/3ATTRACTIONNCT06265051

Tirofiban After Successful MT Recanalization in AIS

A Phase 2/3 study testing Tirofiban in people with Acute Ischemic Stroke and Vessel Occlusion, run by Xiang Luo at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke, Vessel Occlusion
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
1,380 participants
Where
1 siteChina
Study dates
9 Apr 2024to 29 Dec 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

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 old;
  • NIHSS score: 6-30;
  • Symptom onset to random time of 24h, including wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance.
  • mRS 0-1 before the stroke;
  • Subject or legal representative can sign an informed consent form;
  • Clinical symptoms caused by acute occlusion of the following sites confirmed by CTA or MRA: intracranial segment of ICA, M1 segment of middle cerebral artery, M2 trunk of middle cerebral artery;
  • ASPECTS≥6 on NCCT or DWI;
  • After the end of mechanical thrombectomy, the mTICI was stable at 2b/3, and there was no secondary embolism in other non-offending vessels, or the diagnostic angiography before mechanical thrombectomy showed that the occluded vessels improved to mTICI 2b/3, and no mechanical thrombectomy was planned.

Who cannot join

  • Intra-arterial thrombolysis;
  • Tirofiban was used within 24 hours before endovascular treatment
  • Women who are known to be pregnant or lactating, or have a positive pregnancy test before randomization;
  • Allergy to tirofiban, radiocontrast agent or Nitinol materials;
  • Any active bleeding within 30 days before stroke or recent bleeding (gastrointestinal, urinary, etc.);
  • parenchymal organ surgery or biopsy within 14 days before stroke;
Show all 17Show fewer
  • History of heparin-induced thrombocytopenia;
  • Platelet count < 100*10^9/L;
  • Being on hemodialysis or peritoneal dialysis; Known severe renal insufficiency (glomerular filtration rate \&lt; 30ml/min or serum creatinine \&gt; 220μmol/L).
  • Subjects requiring hemodialysis or peritoneal dialysis or who have contraindications to angiography for any reason;
  • The expected survival time is less than half a year (such as malignant tumors, serious heart and lung diseases, etc.);
  • Have participated in other interventional clinical studies that may have an impact on the outcome assessment;
  • Other circumstances that the investigator considers inappropriate for participation in the study or that may pose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorder).
  • The midline shift of the brain or cerebral hernia, ventricular mass effect;
  • Acute intracranial hemorrhage on CT or MRI;
  • New bilateral acute stroke or intracranial multi-drainage large vessel occlusion;
  • Simple extracranial occlusion of the internal carotid artery.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 450001

Other trials in China

About this study

Official title: Safety and Efficacy of Adjunct Tirofiban Treatment After Successful Mechanical Thrombectomy Recanalization in Acute Anterior Circulation Ischemic Stroke- A Multicenter, Prospective, Double-blind, Randomized Trial

Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset.

Read the detailed description

Endovascular treatment is the primary approach for significantly improving the clinical prognosis of patients with acute large vessel occlusion, and it has been consistently recommended by both domestic and foreign guidelines. Successful vascular recanalization and restoration of ischemic tissue reperfusion are crucial for the favorable prognosis of patients with large vessel occlusion. However, the rate of successful reperfusion after endovascular treatment exceeds 80%, but the rate of favorable outcomes at 90 days follow-up is less than 50%. The reasons for ineffective recanalization include reperfusion injury, arterial reocclusion, hemorrhagic transformation, and microvascular reperfusion insufficiency. Although vascular recanalization can be visualized using DSA, not all microvascular beds can be effectively perfused, and persistent microocclusion of the capillary bed in ischemic tissue will also result in a poor prognosis. Currently, drug intervention is not commonly utilized to achieve successful recanalization after mechanical thrombectomy in clinical practice. Additionally, there is a lack of effective methods to improve ineffective recanalization.

Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support.

This is a prospective, randomized, multicenter, double-blind clinical trial. In 52 centers in China, 1360 patients with the following situations will be enrolled: achieved successful recanalization after mechanical thrombectomy (mTICI 2b/3) within 24h of stroke onset.

Patients will be randomly assigned into 2 groups according to the ratio of 1:1:

  1. experimental group received a bolus of tirofiban at a dosage of 5μg/kg (with a maximum dose not exceeding 0.5mg) through the catheter artery, followed by a continuous intravenous infusion at a rate of 0.1μg/(kg·min) for 24 hours.
  2. The control group was given a placebo in the same manner. Face to face interviews will be made on baseline, 24 hours after randomization, 48 hours after randomization, day 7 after randomization or discharge day. Day 90 after randomization will be interviewed by phone or face to face.

The main measure of effectiveness was the rate of mRS 0-2 after 90 days, and the primary focus on safety was the rate of symptomatic intracranial hemorrhage within 48 hours. This study aims to clarify the role of tirofiban in enhancing unsuccessful recanalization after thrombectomy, which holds significant clinical value in improving the prognosis of patients following thrombectomy.

Being tested
Tirofiban, Saline placebo
Keywords
mechanical thrombectomy, acute ischemic stroke, successful recanalization, tirofiban
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

    Also called trade name: Xinweining; Wuhan Grand Pharmaceutical Group Co., LTD. (China)

    After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Tirofiban 5μg/kg was administered intravenously through the catheter artery at a rate of 1ml/min, followed by an intravenous infusion of 0.1μg/(kg·min) for 24 hours. Standard medical treatment was administered after the surgery.

  • Saline placeboDrug

    After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Saline placebo was administered in the same manner as tirofiban group. Standard medical treatment was administered after the surgery.

Study groups in NCT06265051
Study groupRoleWhat they receive
Tirofiban groupExperimentalAfter the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Tirofiban 5μg/kg was administered intravenously through the catheter artery at a rate of 1ml/min, followed by an intravenous infusion of 0.1μg/(kg·min) for 24 hours. Standard medical treatment was administered after the surgery.
Receives: Drug: Tirofiban
placebo groupPlacebo comparatorAfter the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the control group. Saline placebo was administered in the same manner as tirofiban group. Standard medical treatment was administered after the surgery.
Receives: Drug: Saline placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients functionally independent (mRS score 0 to 2) at 90 days

    independent outcome at 90 days

    Measured: 90 days after randomization

  2. Number of participants with symptomatic intracranial hemorrhage

    According to Heidelberg Bleeding Classification

    Measured: within 48 hours of randomization

Secondary outcomes (7)

  1. Modified ranking scale (mRS)

    A 0-6 scale running from perfect health without symptoms to death

    Measured: 90 days after randomization

  2. Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1)

    Excellent functional outcome

    Measured: 90 days after randomization

  3. Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)

    Ambulatory or bodily needs-capable or better

    Measured: 90 days after randomization

  4. Number of participants with improvement of neurological function

    Proportion of patients with an NIHSS score of 0-1 or a reduction of ≥4 points from baseline at 36 hours (24-48 hours) of randomization

    Measured: 36 hours (24-48 hours) after randomization

  5. Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)

    Health-related quality of life

    Measured: 90 days after randomization

  6. All-cause mortality

    The ratio of total deaths from all causes to the research subjects at 90 days of randomization

    Measured: 90 days after randomization

  7. Proportion of intracranial hemorrhage of any type

    Proportion of intracranial hemorrhage of any type within 48 hours of randomization

    Measured: within 48 hours of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start9 Apr 2024
  3. Primary completion29 Dec 2025
  4. Study completion29 Dec 2025

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06265051
Sponsor's protocol ID
100939
Acronym
ATTRACTION
Status last verified
Mar 2026
First submitted
9 Feb 2024
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Renu A, Millan M, San Roman L, Blasco J, Marti-Fabregas J, Terceno M, Amaro S, Serena J, Urra X, Laredo C, Barranco R, Camps-Renom P, Zarco F, Oleaga L, Cardona P, Castano C, Macho J, Cuadrado-Godia E, Vivas E, Lopez-Rueda A, Guimaraens L, Ramos-Pachon A, Roquer J, Muchada M, Tomasello A, Davalos A, Torres F, Chamorro A; CHOICE Investigators. Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial. JAMA. 2022 Mar 1;327(9):826-835. doi: 10.1001/jama.2022.1645.

    PubMed 35143603

  • Dornbos D 3rd, Katz JS, Youssef P, Powers CJ, Nimjee SM. Glycoprotein IIb/IIIa Inhibitors in Prevention and Rescue Treatment of Thromboembolic Complications During Endovascular Embolization of Intracranial Aneurysms. Neurosurgery. 2018 Mar 1;82(3):268-277. doi: 10.1093/neuros/nyx170.

    PubMed 28472526

  • Guan Q, Yun W, Li X, Ni H, Lv W, Xie Z, Zhang L, Zhou J, Xu Y, Li J, Zhang Q. Association of tirofiban with improvement of functional outcomes of direct thrombectomy for acute anterior circulation occlusion: a retrospective, nonrandomized, multicenter, real-world study. Neurosurg Focus. 2023 Oct;55(4):E21. doi: 10.3171/2023.7.FOCUS23150.

    PubMed 37778035

  • RESCUE BT Trial Investigators; Qiu Z, Li F, Sang H, Luo W, Liu S, Liu W, Guo Z, Li H, Sun D, Huang W, Zhang M, Zhang M, Dai W, Zhou P, Deng W, Zhou Z, Huang X, Lei B, Li J, Yuan Z, Song B, Miao J, Liu S, Jin Z, Zeng G, Zeng H, Yuan J, Wen C, Yu Y, Yuan G, Wu J, Long C, Luo J, Tian Z, Zheng C, Hu Z, Wang S, Wang T, Qi L, Li R, Wan Y, Ke Y, Wu Y, Zhu X, Kong W, Huang J, Peng D, Chang M, Ge H, Shi Z, Yan Z, Du J, Jin Y, Ju D, Huang C, Hong Y, Liu T, Zhao W, Wang J, Zheng B, Wang L, Liu S, Luo X, Luo S, Xu X, Hu J, Pu J, Chen S, Sun Y, Jiang S, Wei L, Fu X, Bai Y, Yang S, Hu W, Zhang G, Pan C, Zhang S, Wang Y, Cao W, Yang S, Zhang J, Guo F, Wen H, Zhang J, Song J, Yue C, Li L, Wu D, Tian Y, Yang J, Lu M, Saver JL, Nogueira RG, Zi W, Yang Q. Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial. JAMA. 2022 Aug 9;328(6):543-553. doi: 10.1001/jama.2022.12584.

    PubMed 35943471

  • Zhong HL, Zhou TF, He YK, Li TX, Li ZS. Safety and efficacy of adjunct tirofiban treatment following mechanical thrombectomy for acute ischemic stroke patients with large vessel occlusion (LVO) resulting in successful reperfusion. Interv Neuroradiol. 2024 Oct;30(5):657-662. doi: 10.1177/15910199221138883. Epub 2022 Nov 10.

    PubMed 36358016

  • Huang H, Xu S, Qin T, Wang M, Li G, Liu C, Deng G, Wang Y, Ao D, Xie Y, Zhang Y, Kong Q, Lan L, Yu Y, Huang S, Yu Z, Yi T, Chen W, Zhao W, Su J, Zhou P, Li F, Mei B, Jing P, Zhang J, Du J, Goyal M, Nguyen TN, Wang D, Saver JL, Tang Z, Wang W, Luo X; ATTRACTION Investigators. Efficacy and safety of tirofiban after successful endovascular reperfusion in acute ischaemic stroke (ATTRACTION) in China: a multicentre, double-blind, randomised controlled trial. Lancet. 2026 Jul 18;408(10551):263-274. doi: 10.1016/S0140-6736(26)00983-9. Epub 2026 Jun 24.

    PubMed 42341797

  • Luo X, Huang H, Xu SB, Li G, Zhang Y, Luo Y, Kong Q, Xie Y, Liu CC, Deng G, Wang YH, Ao DH, Lan L, Yu Y, Tang Z, Wang W. Adjunct tirofiban treatment after successful endovascular thrombectomy recanalisation in acute anterior circulation ischaemic stroke (ATTRACTION): protocol of a multicentre, prospective, double-blinded, randomised trial. Stroke Vasc Neurol. 2026 Apr 16:svn-2025-004638. doi: 10.1136/svn-2025-004638. Online ahead of print.

    PubMed 41991238

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tirofiban in people with Acute Ischemic Stroke and Vessel Occlusion, run by Xiang Luo 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 11 Mar 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. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of patients functionally independent (mRS score 0 to 2) at 90 days (time frame: 90 days after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06265051, which also lists 7 linked publications.

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 11 Mar 2026.

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