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Branch Atheromatous DiseasePhase 4STRATEGYNCT05310968

Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction

A Phase 4 study testing Tirofiban hydrochloride sodium chloride injection and Aspirin in people with Branch Atheromatous Disease, run by Beijing Tiantan Hospital at 37 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

Perforating artery territorial infarction (PAI) refers to a single ischemic lesion in a single perforating arterial territory and branch atheromatous disease (BAD) is an important type. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Branch Atheromatous Disease
What is being tested?
Tirofiban hydrochloride sodium chloride injection and Aspirin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
970 participants
Where
37 sitesChina
Study dates
12 Nov 2022to 1 Sep 2025
Phase
Phase 4
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years old;
  • Male or female;
  • Within 48 hours of onset;
  • Clinical symptoms and signs suggest acute single infarction of penetrating artery territory (no cortical involvement, no multifocal involvement, NIHSS ≤10 and consciousness-1a ≤1);
  • DWI suggests single infarction (diameter < 30mm) of penetrating artery territory which involves at least 2 axial layers, or its maximum diameter ≥15mm, or it is connected to the ventral surface of the pons, closing to but not crossing the midline, and located in one side;
  • No severe stenosis (defined as <70%) of parent artery;
  • The patient or his / her legal representative is able and willing to sign the informed consent.

Who cannot join

  • History of intracranial hemorrhage
  • History of intracranial tumors, cerebral arteriovenous malformation, or aneurysm;
  • Emergency endovascular intervention or intravenous thrombolysis before randomization;
  • Dual antiplatelet therapy currently or within 14 days of randomization (excluding use of aspirin and clopidogrel after onset without loading dose of clopidogrel);
  • Use of other antiplatelet drugs (ticagrelor, cilostazol, etc.), anticoagulant drugs, snake venom, defibrase, lumbrukinase or other defibrase treatments after onset;
  • Expected long-term use of non-investigational antiplatelet drugs or non-steroidal anti-inflammatory drugs;
Show all 23Show fewer
  • With severe stenosis (> 70%) of parent artery giving off responsible penetrating artery;
  • Definite indications for anticoagulation (suspicion of cardioembolism, e.g. atrial fibrillation, known heart valve prosthesis, atrial myxoma, endocarditis, etc.) or indications for dual antiplatelet therapy (e.g. recent coronary or cerebral artery stent implantation);
  • Severe hepatic or renal insufficiency before randomization (severe hepatic insufficiency refers to ALT or AST > 3 times the upper limit of normal; severe renal insufficiency refers to creatinine clearance rate (CCr) < 30ml/min);
  • Hemorrhagic tendency (including but not limited to)：PLT<100×10^9/L; heparin treatment within 48h; APTT ≥ 35s; current use of warfarin, INR > 1.7; current use of novel oral anticoagulants; current use of direct thrombin or factor Xa inhibitor;
  • Resistant hypertension which could not be controlled by medicine (SBP > 180mmHg or DBP > 110mmHg);
  • History of obvious head trauma within three months of randomization;
  • History of intracranial or intramedullary surgery within three months of randomization;
  • History of major surgery or severe physical trauma within one month of randomization;
  • Severe neurological defects (mRS ≥ 2) before the onset;
  • Acute pericarditis;
  • Hemorrhagic retinopathy;
  • Childbearing-age women who do not take effective methods of contraception without negative records of pregnancy tests;
  • Known to be allergic to tirofiban;
  • Other surgical or interventional therapy planned within 3 months requiring experimental drugs discontinuation;
  • Life expectancy < 6 months due to any terminal illness;
  • Patients who are undergoing experimental drugs or instruments;
  • Other conditions which suggest participants are unsuitable for this study, e.g. mental diseases, cognitive or mood disturbance,and could not comply with research procedures or with MRI contraindications.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Baotou Central Hospital

    Baotou, Inner Mongolia

  • The First Affiliate Hospital of Baotou Medical College

    Baotou, Inner Mongolia

  • The First Hospital of Fangshan District Beijing

    Beijing, Beijing Municipality

  • Benxi Central Hospital

    Benxi, Liaoning

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • Changzhi People's Hospital

    Changzhi, Shanxi

  • Ningjin People's Hospital

    Dezhou, Shandong

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

  • Hejian People's Hospital

    Hejian, Hebei

  • Mengzhou People's Hospital

    Henan, Henan

  • Xiuwu People's Hospital

    Jiaozuo, Henan

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong

  • Jincheng People's Hospital

    Jincheng, Shanxi

  • Jiyuan Hospital of Traditional Chinese Medicine

    Jiyuan, Henan

  • Guanxian People's Hospital

    Liaocheng, Shandong

  • Liaocheng Central Hospital

    Liaocheng, Shandong

  • The People's Hospital of Gaotang County

    Liaocheng, Shandong

  • The Second People's Hospital of Liaocheng

    Liaocheng, Shandong

  • The Third People's Hospital of Liaocheng

    Liaocheng, Shandong

  • The People's Hospital of Linqing

    Linqing, Shandong

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Affiliated Nantong Hospital of Shanghai University (The Sixth People's Hospital of Nantong)

    Nantong, Jiangsu

  • The People's Hospital of Suxitong Science & Technology Inductrial Park

    Nantong, Jiangsu

  • Tanghe County People's Hospital

    Nanyang, Henan

  • The First People's Hospital of Nanyang

    Nanyang, Henan

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Suixian Hospital of Traditional Chinese Medicine

    Shangqiu, Henan

  • Shaodong People's Hospital

    Shaoyang, Hunan

  • The Affiliated Shuyang Hospital of Xuzhou Medical University

    Suqian, Jiangsu

  • Tangshan Gongren Hospital

    Tangshan, Hebei

  • Weihai Wendeng District People's Hospital

    Weihai, Shandong

  • The First People's Hospital of Xianyang

    Xianyang, Shaanxi

  • The People's Hospital of Qinghe County

    Xingtai, Hebei

  • Wanrong County People's Hospital

    Yuncheng, Shanxi

  • School of Medicine, Xiamen University

    Zhangzhou, Fujian

  • The People's Hospital of Biyang County

    Zhumadian, Henan

  • Zibo Municipal Hospital

    Zibo, Shandong

Other trials in China

About this study

Official title: Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY)

Perforating artery territorial infarction (PAI) refers to a single ischemic lesion in a single perforating arterial territory and branch atheromatous disease (BAD) is an important type. BAD related stroke accounts for 10%-15% ischemic cerebral infarction and is closely related to early neurological deterioration (END). Among patients with single ischemic lesion in other study, dual antiplatelet (clopidogrel plus aspirin) did not significantly reduce the risk of recurrent stroke. The primary purpose of this study is to assess the efficacy and safety of tirofiban combined with aspirin versus placebo combined with aspirin in reducing the risk of stroke and END in patients with BAD.

Read the detailed description

Branch atheromatous disease (BAD) was characterized by cerebral infarction within penetrating artery territories. It arises from atherosclerotic stenosis or occlusion at the origin or proximal segment of these arteries, with three principal pathological manifestations. BAD is the typical etiology of the isolated infarction in penetrating artery territories. There is still no consensus on the classification, and both the TOAST and the CISS (Chinese ischemic stroke subclassification) have the limitations.

Currently, there are no evidence-supported, guideline-based on how to prevent the END of BAD. Combining the pathology of atherosclerosis, we hypothesize that short-term use of tirofiban with aspirin for intensive antiplatelet therapy may confer benefits.

The primary purpose of this study is to assess the efficacy and safety of tirofiban combined with aspirin versus placebo combined with aspirin in reducing END and stroke at 90 days in patients with BAD.

This is a prospective, randomized, multicenter, double-blind clinical trial. In China, 970 patients with the following criteria will be enrolled: single acute infarction of penetrating artery territory (maximum diameter <30 mm on DWI of MRI) within 48 hours, which involves two or more transverse layers, or whose maximum diameter ≥15 mm, , or connected to the ventral surface of the median pons without crossing the midline on DWI image, no severe stenosis (defined as <70%) of parent artery.

Patients will be randomly assigned into 2 groups:

  1. Tirofiban + Aspirin (Day 1-90)
  2. Placebo + Aspirin (Day 1-90) Interviews will be made on baseline, 24 hours after randomization, day 7 after randomization, discharge day, and day 90 after randomization.
Being tested
Tirofiban hydrochloride sodium chloride injection, Tirofiban hydrochloride sodium chloride injection placebo, Aspirin
Keywords
branch atheromatous disease, perforating artery territorial infarction, tirofiban, aspirin, randomized controlled trial, multicenter study, double blind study, placebo-controlled

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tirofiban hydrochloride sodium chloride injectionDrug

    Day 1: Tirofiban will be given by bolus injection at 0.4ug/kg/min for the first 30 minutes, followed by a continuous infusion at 0.1ug/kg/min for the next 24 hours.

  • Tirofiban hydrochloride sodium chloride injection placeboDrug

    Day 1: Tirofiban placebo will be injected at the same rate with experimental group.

  • AspirinDrug

    Day 1: Aspirin 100-300mg per day Day 2-90: Aspirin 100mg per day

Study groups in NCT05310968
Study groupRoleWhat they receive
Tirofiban groupExperimentalThis group will receive tirofiban and aspirin. Day 1: Tirofiban injected intravenously for 24 hours and aspirin of 100-300 mg. Tirofiban will be injected at 0.4 ug/kg/ min for the first 30 minutes and 0.1 ug/kg/min for the next 24 hours. Day 2-90: Aspirin 100mg per day.
Receives: Drug: Tirofiban hydrochloride sodium chloride injection; Drug: Aspirin
Tirofiban placebo groupPlacebo comparatorThis group will receive tirofiban placebo and aspirin. Day 1: Tirofiban placebo injected intravenously for 24 hours and aspirin of 100-300 mg. The placebo will be injected at the same rate with Tirofiban group. Day 2-90: Aspirin 100mg per day.
Receives: Drug: Tirofiban hydrochloride sodium chloride injection placebo; Drug: Aspirin

What is being measured

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

  1. new stroke or END(early neurological deterioration）

    1. Symptoms and signs of acute neurological deficits caused by sudden focal or whole brain, spinal cord, or retinal vascular damage, which are related to cerebral circulatory disorders, including hemorrhagic and ischemic stroke.
    2. NIHSS score increasing by ≥ 2 points, or the score increasing by≥1 in either the motor or consciousness level within 7 days after randomization and intracranial hemorrhage is excepted by CT or MRI. Exacerbations not attributable to stroke are also excluded such as cardiac failure, liver and renal failure, etc.

    Measured: 90 days after randomization

Secondary outcomes (5)

  1. new stroke or END

    1)Symptoms and signs of acute neurological deficits caused by sudden focal or whole brain, spinal cord, or retinal vascular damage, which are related to cerebral circulatory disorders, including hemorrhagic and ischemic stroke. 2)NIHSS score increasing by ≥ 2 points, or the score increasing by≥1 in either the motor or consciousness level within 7 days after randomization and intracranial hemorrhage is excepted by CT or MRI. Exacerbations not attributable to stroke are also excluded such as cardiac failure, liver and renal failure, etc.

    Measured: 24 hours and 7 days after randomization

  2. Composite vascular events

    Symptomatic stroke, myocardial infarction and vascular death.

    Measured: 90 days after randomization

  3. Disability or death

    The modified Rankin Scale (mRS) is 2-6 points.

    Measured: 90 days after randomization

  4. Improvement of neurological function

    decrease of NIHSS score by ≥4 points or NIHSS score of 0-1 point

    Measured: 24 hours, 7 days, and 90 days after randomization

  5. EQ-5D-5L Scale

    It describes the state of health.

    Measured: 90 days after randomization

Timeline

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

  1. First posted5 Apr 2022
  2. Study start12 Nov 2022
  3. Primary completion17 Feb 2025
  4. Study completion1 Sep 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
970 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05310968
Sponsor's protocol ID
KY2021-089-08
Acronym
STRATEGY
Status last verified
Jan 2026
First submitted
27 Mar 2022
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lu H, Howatt DA, Balakrishnan A, Graham MJ, Mullick AE, Daugherty A. Hypercholesterolemia Induced by a PCSK9 Gain-of-Function Mutation Augments Angiotensin II-Induced Abdominal Aortic Aneurysms in C57BL/6 Mice-Brief Report. Arterioscler Thromb Vasc Biol. 2016 Sep;36(9):1753-7. doi: 10.1161/ATVBAHA.116.307613. Epub 2016 Jul 28.

    PubMed 27470509

  • Seitz RJ, Meisel S, Moll M, Wittsack HJ, Junghans U, Siebler M. The effect of combined thrombolysis with rtPA and tirofiban on ischemic brain lesions. Neurology. 2004 Jun 8;62(11):2110-2. doi: 10.1212/01.wnl.0000129480.17345.4a.

    PubMed 15184627

  • Berberich A, Schneider C, Reiff T, Gumbinger C, Ringleb PA. Dual Antiplatelet Therapy Improves Functional Outcome in Patients With Progressive Lacunar Strokes. Stroke. 2019 Apr;50(4):1007-1009. doi: 10.1161/STROKEAHA.118.023789.

    PubMed 30841818

  • Coull AJ, Lovett JK, Rothwell PM; Oxford Vascular Study. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004 Feb 7;328(7435):326. doi: 10.1136/bmj.37991.635266.44. Epub 2004 Jan 26.

    PubMed 14744823

  • Jeong HG, Kim BJ, Yang MH, Han MK, Bae HJ. Neuroimaging markers for early neurologic deterioration in single small subcortical infarction. Stroke. 2015 Mar;46(3):687-91. doi: 10.1161/STROKEAHA.114.007466. Epub 2015 Feb 12.

    PubMed 25677600

  • Cohen JE, Rabinstein A, Gomori JM, Leker RR. Capsular warning syndrome and crescendo lacunar strokes after atherosclerotic stenosis of the recurrent artery of Heubner. J Clin Neurosci. 2012 Dec;19(12):1730-3. doi: 10.1016/j.jocn.2012.04.010. Epub 2012 Sep 19.

    PubMed 22999563

  • Del Bene A, Palumbo V, Lamassa M, Saia V, Piccardi B, Inzitari D. Progressive lacunar stroke: review of mechanisms, prognostic features, and putative treatments. Int J Stroke. 2012 Jun;7(4):321-9. doi: 10.1111/j.1747-4949.2012.00789.x. Epub 2012 Mar 30.

    PubMed 22463492

  • Sudlow CL, Warlow CP. Comparable studies of the incidence of stroke and its pathological types: results from an international collaboration. International Stroke Incidence Collaboration. Stroke. 1997 Mar;28(3):491-9. doi: 10.1161/01.str.28.3.491.

    PubMed 9056601

  • Caplan LR. Lacunar infarction and small vessel disease: pathology and pathophysiology. J Stroke. 2015 Jan;17(1):2-6. doi: 10.5853/jos.2015.17.1.2. Epub 2015 Jan 30.

    PubMed 25692102

  • Bang OY. Intracranial atherosclerosis: current understanding and perspectives. J Stroke. 2014 Jan;16(1):27-35. doi: 10.5853/jos.2014.16.1.27. Epub 2014 Jan 31.

    PubMed 24741562

  • Kim BJ, Kim JS. Ischemic stroke subtype classification: an asian viewpoint. J Stroke. 2014 Jan;16(1):8-17. doi: 10.5853/jos.2014.16.1.8. Epub 2014 Jan 31.

    PubMed 24741560

  • Kim JS, Yoon Y. Single subcortical infarction associated with parental arterial disease: important yet neglected sub-type of atherothrombotic stroke. Int J Stroke. 2013 Apr;8(3):197-203. doi: 10.1111/j.1747-4949.2012.00816.x. Epub 2012 May 9.

    PubMed 22568537

  • Fisher CM. Capsular infarcts: the underlying vascular lesions. Arch Neurol. 1979 Feb;36(2):65-73. doi: 10.1001/archneur.1979.00500380035003.

    PubMed 420625

  • Caplan LR. Intracranial branch atheromatous disease: a neglected, understudied, and underused concept. Neurology. 1989 Sep;39(9):1246-50. doi: 10.1212/wnl.39.9.1246. No abstract available.

    PubMed 2671793

  • Wang Y, Liao X, Feng S, Pan Y, Wang X, Qu H, Liu Y, Gao C, Liu X, Yang Q, Zhang M, Liu Z, Ye J, Mao Y, Chen W, Jiang L, Bath PM, Johnston SC, Turc G, Zhao X, Wang Y, Wang Y; STRATEGY Investigators. Tirofiban for Branch Atheromatous Disease-Related Stroke: The STRATEGY Randomized Clinical Trial. JAMA Neurol. 2026 Aug 31. doi: 10.1001/jamaneurol.2026.2855. Online ahead of print.

    PubMed 42671865

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tirofiban hydrochloride sodium chloride injection and Aspirin in people with Branch Atheromatous Disease, run by Beijing Tiantan Hospital at 37 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 7 inclusion and 23 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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. 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 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?

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?

new stroke or END(early neurological deterioration） (time frame: 90 days after randomization). 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 NCT05310968, which also lists 16 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 13 Jan 2026.

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