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Stroke, Acute IschemicPhase 2/3ADJUVANTNCT05728333

Intravenous Tirofiban Versus Thrombolysis Before Mechanical Thrombectomy in Stroke

A Phase 2/3 study testing Tirofiban and Thrombolysis in people with Stroke, Acute Ischemic, run by Xinqiao Hospital of Chongqing at 42 sites 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

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or thrombolysis before endovascular thrombectomy has not been well investigated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute Ischemic
What is being tested?
Tirofiban and Thrombolysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,014 participants
Where
42 sitesChina
Study dates
28 Nov 2023to 25 May 2026
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

  • Aged 18 years or older;
  • Acute ischemic stroke patient eligible for intravenous thrombolysis who are present within 4.5 hours of last known well, or present within 4.5-24 hours of last known well with demonstrated salvageable brain tissue (defined as an estimated ischemic core volume <70 ml, a mismatch ratio ≥1.8 and a mismatch volume ≥15 ml);
  • Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, or basilar artery confirmed by CTA or MRA;
  • Endovascular thrombectomy is planned by clinical care team;
  • Informed written consent obtained from patients or their legal representatives.

Who cannot join

  • Acute intracranial hemorrhage on admission;
  • Contraindication to intravenous thrombolytics or tirofiban;
  • Pretreatment with intravenous thrombolysis after index stroke;
  • Significant pre-stroke disability defined as a modified Rankin scale (mRS) score greater than 2;
  • Known pregnancy or lactation;
  • Allergy to radiographic contrast agents, nickel, titanium metals or their alloys;
Show all 12Show fewer
  • Current participation in other drug clinical trials;
  • Arterial tortuosity and/or other arterial disease that would prevent the thrombectomy device from reaching the target vessel;
  • Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments;
  • Radiologically confirmed mass effect or intracranial tumor except for small meningioma;
  • Radiologically confirmed intracranial arteriovenous malformation or aneurysm.
  • Any terminal disease with a life expectancy less than half a year.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

China42 sites

  • Changxing people's hospital

    Changxing, Zhejiang, 313100

  • Chongzhou People's Hospital

    Chongzhou, Sichuan, 611230

  • Dali Bai Autonomous Prefecture People's Hospital

    Dali, Yunnan, 671000

  • Taihe County People's Hospital

    Fuyang, Anhui, 236600

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi, 341000

  • Xingguo People's Hospital, Xinguo Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 342414

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570100

  • Haining People's Hospital

    Haining, Zhejiang, 314400

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310000

  • Tongde Hospital of Zhejiang Province

    Hangzhou, Zhejiang, 310012

  • The First Affiliated Hospital, Hengyang Medical School, University of South China

    Hengyang, Hunan, 421001

  • Huai'an First People's Hospital, the Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University

    Huai'an, Jiangsu, 223300

  • HuZhou Central Hospital

    Huzhou, Zhejiang, 313000

  • The First People's Hospital of Huzhou

    Huzhou, Zhejiang, 313000

  • The First Affiliated Hospital of Henan Polytechnic University (Jiaozuo Second People's Hospital)

    Jiaozuo, Henan, 454000

  • The First People's Hospital of Jiashan

    Jiashan, Zhejiang, 314100

  • The Second Affiliated Hospital of Jiaxing

    Jiaxing, Zhejiang, 314000

  • Jingdezhen First People's Hospital

    Jingdezhen, Jiangxi, 333000

  • Linhai Second People's Hospital

    Linhai, Zhejiang, 317016

  • Lishui People's Hospital

    Lishui, Zhejiang, 323000

  • Longyan First Hospital of Fujian Medical University

    Longyan, Fujian, 364000

  • The First People's Hospital of Mianyang (Mianyang 404 Hospital)

    Mianyang, Sichuan, 621000

  • The Affiliated First Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315040

  • Beilun District People's Hospital

    Ningbo, Zhejiang, 315800

  • The First People's Hospital of Pinghu

    Pinghu, Zhejiang, 314200

  • Quanzhou County People's Hospital

    Quanzhou, Guangxi, 541500

  • Affiliated Shaoxing Shangyu People's Hospital, School of Medicine, Zhejiang University

    Shangyu, Zhejiang, 312300

  • Shenqiu County People's Hospital

    Shenqiu, Henan, 466300

  • Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University

    Taizhou, Zhejiang, 317000

  • Taizhou Central Hospital（Taizhou University Affiliated Hospital）

    Taizhou, Zhejiang, 318000

  • Taizhou municipal hospital

    Taizhou, Zhejiang, 318000

  • Taizhou First People's Hospital

    Taizhou, Zhejiang, 318020

  • The First People's Hospital of Tongxiang

    Tongxiang, Zhejiang, 314500

  • Xihua People's Hospital

    Wacheng Neighborhood, Henan, 466600

  • The First People's Hospital of Wenling

    Wenling, Zhejiang, 317500

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Yijishan Hospital of Wannan Medical University

    Wuhu, Anhui, 241000

  • The 904th Hospital of The People's Liberation Army

    Wuxi, Jiangsu, 214000

  • Haiyan People's Hospital

    Wuyuan, Zhejiang, 314300

  • Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)

    Xiangtan, Hunan, 411100

Other trials in China

About this study

Official title: Intravenous Adjuvant With Tirofiban Versus Thrombolysis Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or thrombolysis before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus thrombolysis for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.

Read the detailed description

Intravenous thrombolysis bridging with endovascular treatment (EVT) has been proven to be effective therapy in acute ischemic stroke patients due to large vessel occlusion (LVO). Several randomized controlled trials, aiming to explore the benefits and risks of intravenous thrombolysis prior to EVT in LVO stroke, have suggested that intravenous thrombolysis should not be omitted. Although intravenous thrombolysis results in successful reperfusion in approximately 10% to 20% of LVO patients, obviating the need for EVT, it has limitations. First, the time window for intravenous thrombolysis is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, thrombolysis is expensive. The above limitations lead to a very low proportion of patients who receive intravenous thrombolysis. Tirofiban is a selective IIb/IIIa receptor inhibitor, and it's effective in preventing thrombosis complications. Intravenous tirofiban has been increasingly used as an adjunctive treatment in acute ischemic stroke patients receiving EVT. However, a direct comparison between tirofiban and thrombolysis in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus thrombolysis prior to EVT for acute ischemic stroke patients with LVO.

Being tested
Tirofiban, Thrombolysis
Keywords
endovascular thrombectomy, large vessel occlusion, intravenous thrombolysis, 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 Tirofiban & EVT

    Intravenous tirofiban before endovascular thrombectomy.

  • ThrombolysisDrug

    Also called Thrombolysis & EVT

    Intravenous thrombolysis before endovascular thrombectomy.

Study groups in NCT05728333
Study groupRoleWhat they receive
TirofibanExperimentalTirofiban will be administrated intravenously before endovascular thrombectomy.
Receives: Drug: Tirofiban
ThrombolysisActive comparatorThrombolytics will be administrated intravenously before endovascular thrombectomy.
Receives: Drug: Thrombolysis

What is being measured

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

  1. Functional independence

    modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

    Measured: 90 days post-endovascular treatment

Secondary outcomes (10)

  1. Modified Rankin scale score at 90 days

    Measured: 90 days post-endovascular treatment

  2. Excellent outcome

    Modified Rankin Scale score 0 to 1, or Modified Rankin scale score return to baseline

    Measured: 90 days post-endovascular treatment

  3. Successful reperfusion before thrombectomy

    The expanded Thrombolysis In Cerebral Infarction (eTICI) reperfusion grading system is a 6-point scale: 0 indicates no reperfusion noted; 1, reduction in thrombus without filling of distal arterial branches; 2a, reperfusion of <50% of the territory; 2b, a reperfusion of ≥50% of the territory; 2c, near-complete perfusion with distal slow flow or presence of small cortical emboli; and 3, complete reperfusion. Successful reperfusion at initial angiogram prior to thrombectomy was defined as an eTICI grade of 2b, 2c, or 3 on the first intracranial angiogram.

    Measured: Prior to thrombectomy

  4. Successful reperfusion on the final angiogram

    Achieve eTICI 2b, 2c or 3

    Measured: End-of-procedure angiography

  5. First pass excellent reperfusion

    Achieve eTICI 2c or 3

    Measured: After the first thrombectomy pass

  6. First pass successful reperfusion

    Achieve eTICI 2b, 2c or 3

    Measured: After the first thrombectomy pass

  7. Time from puncture to reperfusion or procedure completion

    Measured: from puncture to reperfusion or procedure completion

  8. Use of balloon angioplasty or stenting during procedure

    Measured: During endovascular treatment

  9. National Institutes of Health Stroke Scale score at 5 to 7 days or discharge if earlier

    Scores on National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with less scores indicating less severe neurologic deficits.

    Measured: At 5 to 7 days post-endovascular treatment or discharge if earlier

  10. EQ-5D-5L scale score at 90 days

    Scores on the European Quality Five-Dimension Five-Level Self-Report Questionnaire (EQ-5D-5L) range from -0.39 to 1, with higher scores indicating a better quality of life; 0 is the value of a health state equivalent to death.

    Measured: 90 days post-endovascular treatment

Timeline

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

  1. First posted15 Feb 2023
  2. Study start28 Nov 2023
  3. Primary completion25 May 2026
  4. Study completion25 May 2026

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
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
1,014 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05728333
Sponsor's protocol ID
ADJUVANT
Acronym
ADJUVANT
Status last verified
Sep 2026
First submitted
2 Feb 2023
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Zi W, Qiu Z, Li F, Sang H, Wu D, Luo W, Liu S, Yuan J, Song J, Shi Z, Huang W, Zhang M, Liu W, Guo Z, Qiu T, Shi Q, Zhou P, Wang L, Fu X, Liu S, Yang S, Zhang S, Zhou Z, Huang X, Wang Y, Luo J, Bai Y, Zhang M, Wu Y, Zeng G, Wan Y, Wen C, Wen H, Ling W, Chen Z, Peng M, Ai Z, Guo F, Li H, Guo J, Guan H, Wang Z, Liu Y, Pu J, Wang Z, Liu H, Chen L, Huang J, Yang G, Gong Z, Shuai J, Nogueira RG, Yang Q; DEVT Trial Investigators. Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):234-243. doi: 10.1001/jama.2020.23523.

    PubMed 33464335

  • 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

  • Sang H, Zheng Z, Ni H, Gu X, Xia W, Huang H, Liu K, Zhou Y, Jiang L, Li L, Yuan G, Cui T, Jiang S, Li Y, Jiang Y, Fang X, Huang X, Li M, Liu F, Lin C, Fan X, Feng D, Zhang L, Campbell BCV, Albers GW, Nogueira RG, Nguyen TN, Wang D, Saver JL, Yang Q, Qiu Z, Yin C; ADJUVANT investigators. ADJUVANT Randomized Controlled Trial: Rationale and Design. J Am Heart Assoc. 2026 Mar 17;15(6):e045967. doi: 10.1161/JAHA.125.045967. Epub 2026 Mar 4.

    PubMed 41778584

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tirofiban and Thrombolysis in people with Stroke, Acute Ischemic, run by Xinqiao Hospital of Chongqing at 42 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 5 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 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. 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?

Functional independence (time frame: 90 days post-endovascular treatment). 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 NCT05728333, which also lists 3 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 14 Sep 2026.

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