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Acute Ischemic StrokePhase 3PROST-2NCT05700591

rhPro-UK in Acute Ischaemic Stroke Within 4.5 Hours of Stroke Onset Trial 2(PROST-2)

A Phase 3 study testing rhPro-UK and rt-PA in people with Acute Ischemic Stroke, run by Tasly Biopharmaceuticals Co., Ltd. at 72 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

Intravenous thrombolysis is the first-line therapy in patients with acute ischemic stroke within 4·5 hours of symptom onset, and recombinant tissue plasminogen activator (alteplase) is the preferred thrombolytic agent for this purpose. RhPro-UK is a specific plasminogen activator. 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?
rhPro-UK and rt-PA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,552 participants
Where
72 sitesChina
Study dates
29 Jan 2023to 14 Mar 2024
Phase
Phase 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

  • Clinically diagnosed as acute ischemic stroke (according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018).
  • 18 years or older, male or female.
  • NIH Stroke Scale（NIHSS）scores of 4 to 25.
  • Treatment within 4.5 hours after stroke onset.
  • The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
  • Informed consent by patient or by patient's guardians.

Who cannot join

  • Prestroke modified rankin scale of ≥2.
  • Large areas of hypodense ischaemic changes on baseline CT（Infarction area> 1/3 of the middle cerebral artery feeding area）.
  • Intracranial hemorrhage.
  • Previous history of intracranial hemorrhage.
  • Severe cerebral trauma or stroke history within 3 months.
  • Intracranial tumor or giant intracranial aneurysm.
Show all 25Show fewer
  • Intracranial or intraspinal surgery within the past 3 months.
  • Gastrointestinal or urinary bleeding within the past 3 weeks.
  • History of major surgical procedures or severe trauma within the last 2 weeks (investigator evaluation).
  • Puncture in 1 week which can not be oppressed.
  • Active visceral hemorrhage.
  • Aortic arch dissection.
  • Bacterial endocarditis or pericarditis.
  • Planned for thrombectomy.
  • Patients with systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg after anti-hypertension treatment.
  • High risk of acute hemorrhage include platelet count<10^9/L.
  • Received low molecular weight heparin or heparin within 24 hours.
  • Using of thrombin inhibitors or factor Xa inhibitor within the past 48 hours.
  • Using of oral anticoagulant drugs and PT >15s or INR >1.7.
  • Patients with epilepsy or other mental disorders that could not be adhered to at the beginning of stroke.
  • Blood glucose < 2.8 mmol/L or > 22.2 mmol/L.
  • Allergies to rhPro-UK or rt-PA active ingredients or other components.
  • Pregnant women or beastfeeding women.
  • Participants in other clinical trials within the past month.
  • The investigator believes that the patient is not suitable for the study.

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

China72 sites

  • Ansteel Group General Hospital

    Anshan, Liaoning

  • Anyang People's Hospital

    Anyang, Henan

  • Baogang Hospital of Inner Mongolia

    Baotou, Inner Mongolia

  • Baotou Central Hospital

    Baotou, Inner Mongolia

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science & Technology

    Baotou, Inner Mongolia

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Benxi Central Hospital

    Benxi, Liaoning

  • Jilin Guowen Hospital

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • Beipiao Central Hospital

    Chaoyang, Liaoning

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Keshiketeng Hospital of Traditional Chinese Medicine and Mongolian Medicine

    Chifeng, Inner Mongolia

  • The Affiliated Hospital of Chifeng University

    Chifeng, Inner Mongolia

  • Dalian Municipal Central Hospital

    Dalian, Liaoning

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang

  • Daqing People's Hospital

    Daqing, Heilongjiang

  • Sinopharm Tongmei General Hospital

    Datong, Shanxi

  • Dezhou People's Hospital

    Dezhou, Shandong

  • Tengzhou Central People's Hospital

    Dezhou, Shandong

  • Shengli Oilfield Central Hospital

    Dongying, Shandong

  • Fukuang General Hospital of Liaoning Health Industry Group

    Fushun, Liaoning

  • Fuxinkuang General Hospital of Liaoning Health Industry Group

    Fuxin, Liaoning

  • Huizhou First Hospital

    Guangdong, Guangdong

  • Handan Central Hospital

    Handan, Hebei

  • Hengshui People's Hospital (Harrison International Peace Hospital)

    Hengshui, Hebei

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • Jinan City People's Hospital

    Jinan, Shandong

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

  • Liaocheng People's Hospital

    Liaocheng, Shandong

  • Linfen Central Hospital

    Linfen, Shanxi

  • Linfen People's Hospital

    Linfen, Shanxi

  • Linyi People's Hospital

    Linyi, Shandong

  • Luoyang Central Hospital

    Luoyang, Henan

  • Meihekou Central Hospital

    Meihekou, Jilin

  • Mianyang Central Hospital

    Mianyang, Sichuan

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

  • First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan

  • Nanshi Hospital of Nanyang

    Nanyang, Henan

  • Nanyang Second General Hospital

    Nanyang, Henan

  • General Hospital of Pingmei Shenma Medical Group

    Pingdingshan, Henan

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality

  • Yuebei People's Hospital

    Shaoguan, Guangdong

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning

  • The First People's Hospital of Shenyang

    Shenyang, Liaoning

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning

  • The PLA General Hospital of Northern Theater Command

    Shenyang, Liaoning

  • Hebei General Hospital

    Shijiazhuang, Hebei

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Jilin Neuropsychiatric Hospital

    Siping, Jilin

  • Tai'an Central Hospital

    Tai’an, Shandong

  • Taizhou First People's Hospital

    Taizhou, Zhejiang

  • Zhejiang Taizhou Hospital

    Taizhou, Zhejiang

  • First People's Hospital of Tancheng

    Tancheng, Shandong

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality

  • Tonghua Central Hospital

    Tonghua, Jilin

  • Tongji Hospital affiliated to Huazhong University of Science and Technology

    Wuhan, Hubei

  • Wuhan Fourth Hospital

    Wuhan, Hubei

  • Xiangyang Central Hospital

    Xiangyang, Hubei

  • Xianyang Hospital Of Yan'an University

    Xianyang, Shaanxi

  • Xingtai People's Hospital

    Xingtai, Hebei

  • Xinxiang Central Hospital

    Xinxiang, Henan

  • Xuancheng People's Hospital

    Xuancheng, Anhui

  • General Hospital of Xuzhou Coal Mining Group

    Xuzhou, Jiangsu

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei

  • Zhumadian Central Hospital

    Zhumadian, Henan

Other trials in China

About this study

Official title: A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset

Intravenous thrombolysis is the first-line therapy in patients with acute ischemic stroke within 4·5 hours of symptom onset, and recombinant tissue plasminogen activator (alteplase) is the preferred thrombolytic agent for this purpose.

RhPro-UK is a specific plasminogen activator. rhPro-UK only acts on occlusive thrombus and has little effect on hemostatic thrombus. In addition, rhPro-UK does not form covalent complexes with protease inhibitors in plasma, so the concentrations of rhpro-UK and protease inhibitors in the blood do not decrease compared with alteplase. Therefore, rhPro-UK therapies have a potential advantage of less systemic bleeding in treated subjects. Data from several previous studies suggest that rhPro-UK is efficacious when used to treat patients with acute myocardial infarction. On April 2, 2011, rhPro-UK injection was approved by the National Medical Products Administration to treat acute myocardial infarction. Since then, rhPro-UK has been widely used to treat myocardial infarction in China.

Since 2016, a phase 2 clinical trial was carried to explore the dosing of rhPro-UK in patients with acute ischemic stroke, followed by another study with a sample size of 680 patients to initially validate the efficacy and safety of the proposed dose of 35mg. The results of these studies suggested that rhPro-UK was effective, and there were no safety concerns. To further prove the efficacy and safety of rhPro-UK in patients with acute ischemic stroke, investigators conducted this phase 3 study (PROST-2).

Being tested
rhPro-UK, rt-PA
Medical subject headings
Ischemic Stroke

What participants receive

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

  • rhPro-UKDrug

    35 mg, administered intravenously with a bolus of 15 mg within 3 minutes and the remainder by continuous infusion within 30 minutes

  • rt-PADrug

    0.9 mg/kg (maximum 90 mg), with 10% administered intravenously as a bolus, followed by 90% infusion within 1 hour

Study groups in NCT05700591
Study groupRoleWhat they receive
rhPro-UKExperimentalRecombinant Human Pro-urokinase (rhPro-UK)
Receives: Drug: rhPro-UK
rt-PAActive comparatorAlteplase(rt-PA)
Receives: Drug: rt-PA

What is being measured

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

  1. The proportion of patients with excellent functional outcome at 90 days

    A score of 0 or 1 on the modified Rankin scale(which ranges from 0 [no symptoms] to 6 [death]) at 90 days indicated an excellent functional outcome.

    Measured: 90±7 days

Secondary outcomes (13)

  1. The proportion of patients with independent functional outcome at 90 days

    A score of 0-2 on the modified Rankin scale(which ranges from 0 [no symptoms] to 6 [death]) at 90 days indicated an independent functional outcome.

    Measured: 90±7 days

  2. Functional handicap

    The distribution of the modified Rankin scale(which ranges from 0 [no symptoms] to 6 [death]) at 90 days

    Measured: 90±7 days

  3. The proportion of patients with neurological improvement at 24 hours

    A reduction in NIHSS score of ≥4 or a score of 0-1 indicated neurological improvement. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.

    Measured: 22-36 hours

  4. The proportion of patients with neurological improvement at 7 days

    A reduction in NIHSS score of ≥4 or a score of 0-1 indicated neurological improvement. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.

    Measured: 7 ±2 days

  5. The change of neurological function at 24 hours

    NIHSS score was used to assess neurological function. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.

    Measured: 22-36 hours

  6. The change of neurological function at 7 days

    NIHSS score was used to assess neurological function. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.

    Measured: 7 ±2 days

  7. Self-care ability in daily life

    The Barthel Index(which ranges from 0[complete dependence on help with activities of daily living] to 100[independence]) of 95-100 at 90 days

    Measured: 90±7 days

  8. All-cause death within 7 days

    Measured: 7 days

  9. All-cause death within 90 days

    Measured: 90 days

  10. Symptomatic intracranial hemorrhage defined as SITS-MOST

    Measured: 22-36 hours

  11. Symptomatic intracranial hemorrhage defined as ECASSIII

    Measured: 7 days

  12. Any intracranial hemorrhage

    Measured: 7 days

  13. Any systematic bleeding event（defined as ISTH）

    Measured: 7 days

Timeline

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

  1. First posted26 Jan 2023
  2. Study start29 Jan 2023
  3. Primary completion14 Mar 2024
  4. Study completion14 Mar 2024

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05700591
Sponsor's protocol ID
TASLY-B1440-CTP-Ⅲc
Acronym
PROST-2
Status last verified
Jul 2024
First submitted
17 Jan 2023
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Li S, Gu HQ, Feng B, Li H, Wang X, Dong Q, Fan D, Xu Y, Zhu S, Dai H, Wei Y, Wang Z, Lu G, Ma Y, Li Z, Wang Y, Meng X, Zhao X, Liu L, Wang Y; PROST-2 investigators. Safety and efficacy of intravenous recombinant human prourokinase for acute ischaemic stroke within 4.5 h after stroke onset (PROST-2): a phase 3, open-label, non-inferiority, randomised controlled trial. Lancet Neurol. 2025 Jan;24(1):33-41. doi: 10.1016/S1474-4422(24)00436-8. Epub 2024 Nov 29.

    PubMed 39617030

  • Li S, Gu HQ, Feng B, Dong Q, Fan D, Xu Y, Zhu S, Wang Y. RhPro-UK in acute ischemic stroke within 4.5 h of stroke onset trial-2 (the PROST-2 study): Rationale and design of a multicenter, prospective, randomized, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial. Int J Stroke. 2024 Dec;19(10):1182-1187. doi: 10.1177/17474930241265654. Epub 2024 Aug 3.

    PubMed 38907679

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhPro-UK and rt-PA in people with Acute Ischemic Stroke, run by Tasly Biopharmaceuticals Co., Ltd. at 72 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 6 inclusion and 25 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 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 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 phase mean?

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?

The proportion of patients with excellent functional outcome at 90 days (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?

On the ClinicalTrials.gov record for NCT05700591, which also lists 2 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 26 Jul 2024.

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