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Acute Ischaemic StrokePhase 3NCT03541668

Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)

A Phase 3 study testing Recombinant human urokinase and Alteplase in people with Acute Ischaemic Stroke, run by Tasly Biopharmaceuticals Co., Ltd. at 35 sites in China.

Completed

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

Official record
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Trial summary

This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for patients with acute ischaemic stroke in 4.5 hours after stroke onset. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischaemic Stroke
What is being tested?
Recombinant human urokinase and Alteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
674 participants
Where
35 sitesChina
Study dates
18 May 2018to 24 May 2020
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ischemic stroke with symptoms of neurological deficits.
  • Aged 18 to 80 years（including the critical value）.
  • NIH Stroke Scale（NIHSS）scores of 4 to 25（including the critical value）.
  • Treatment within 4.5 hours after stroke onset.
  • The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
  • CT showed negative or signs of early infarction.
  • Informed Consent Form signed by the patients or family (legal representatives) must be provided.

Who cannot join

  • Patients with premorbid modified Rankin Scale (mRS) score ≥2
  • CT showed multiple infarctions（low density> 1/3 cerebral hemisphere）.
  • Transient ischemic attack.
  • Epileptic seizure after stroke.
  • Intracranial tumor, arteriovenous malformation and aneurysm.
  • Iatrogenic Stroke.
Show all 25Show fewer
  • Planned for thrombectomy.
  • Cardioembolism and atrial fibrillation.
  • Myocardial infarction history within 3 months.
  • Severe cerebral trauma or stroke history within 3 months.
  • Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment.
  • Intracranial hemorrhage or subarachnoid hemorrhage on baseline.
  • Active visceral hemorrhage.
  • Patients with intracerebral hemorrhage history.
  • Patients with diabetic retinopathy history.
  • Puncture in 1 week which can not be oppressed.
  • Major surgery or severe trauma within 2 weeks.
  • Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
  • Heparin treatment within 48h and increased APTT is above ULN.
  • Using of oral anticoagulant drugs and PT >15s or INR >1.7.
  • High risk of acute hemorrhage include platelet count<10^9/L.
  • Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination.
  • Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
  • Pregnancy, lactating or menstrual women.
  • The investigator believes that the patient is not suitable for the study.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 100053

  • Baotou Central Hospital

    Baotou, Inner Mongolia

  • Beijing Luhe Hospital,Capital Medical University

    Beijing, Beijing Municipality

  • XuanWu Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • First Hospital of Jilin University

    Changchun, Jilin

  • The First Hospital of Changsha

    Changsha, Hunan

  • The People's Hospital of Sichuan Province

    Chengdu, Sichuan

  • Dalian Municipal Central Hospital

    Dalian, Liaoning

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang

  • Deyang people's hospital

    Deyang, Sichuan

  • The First Hospital of Handan

    Handan, Hebei

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Harrison International Peace Hospital

    Hengshui, Hebei

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia

  • Huai'an First People's Hospital

    Huai'an, Jiangsu

  • The Second People'Hospital of Huai'an

    Huai'an, Jiangsu

  • Liaocheng People's Hospital

    Liaocheng, Shandong

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi

  • Luoyang Central Hospital

    Luoyang, Zhengzhou

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • Shenyang Military Region General Hospital

    Shenyang, Liaoning

  • The 163th Hospital of the Chinese People's Liberation Army

    Shenyang, Liaoning

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Neuropsychiatric Hospital of Jilin Province

    Siping, Jilin

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

  • Tangshan Gongren Hospital

    Tangshan, Hebei

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

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

This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for patients with acute ischaemic stroke in 4.5 hours after stroke onset.

Being tested
Recombinant human urokinase, Alteplase

What participants receive

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

  • Recombinant human urokinaseDrug

    Also called rhPro-UK

    Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3 minutes followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 minutes.

  • AlteplaseDrug

    Also called rt-PA

    Patients receive rt-PA in a dose of 0.9mg per kilogram of body weight(maximum,90 mg),10 percent of which was given as a blous followed by delivery of the remaining 90 percent as a constant infusion over a period of 60 minutes.

Study groups in NCT03541668
Study groupRoleWhat they receive
Group AExperimentalRecombinant human urokinase (rhPro-UK)
Receives: Drug: Recombinant human urokinase
Group BActive comparatorAlteplase(rt-PA)
Receives: Drug: Alteplase

What is being measured

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

  1. Functional handicap

    Proportion of patients achieving a Modified Rankin Scale(mRS,which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) of 0 to 1 at 90 days after treatment.

    Measured: 90days

Secondary outcomes (10)

  1. Proportion of Neurological Improvement

    Proportion of patients achieving a NIHSS(national institutes of health stroke scale) ≦1 or reduction of ≥4 NIHSS points at 24 hours after treatment.

    Measured: 90 days

  2. Scores of Neurological Improvement

    NIHSS changes from baseline at 24 hours after treatment

    Measured: 24 hours

  3. Long-term Change from Baseline

    NIHSS, mRS and Barthel Index(which assesses the ability to perform activities of daily living, on a scale that ranges from 0 to 100) changes from baseline on 90 days after treatment.

    Measured: 90 days

  4. Proportion of Long-term Improvement

    Proportion of patients achieving a mRS of 0 to 2 and a Barthel Index of 75 to 100 at 90 days after treatment.

    Measured: 90 days

  5. Systemic hemorrhage

    Severe systemic hemorrhage

    Measured: 90days

  6. Symptomatic intracerebral hemorrhage

    Symptomatic intracerebral hemorrhage (sICH)

    Measured: 90days

  7. Death

    Death

    Measured: 7 days and 90 days

  8. Recurrence

    Recurrence of stroke

    Measured: 7 days

  9. Liver function

    The incidence of ALT≥3ULN in liver biochemical examination

    Measured: 7 days

  10. Renal function

    The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value

    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 posted30 May 2018
  2. Study start18 May 2018
  3. Primary completion14 Apr 2020
  4. Study completion24 May 2020

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
None (open label)
Enrolment
674 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03541668
Sponsor's protocol ID
TASLY-B1440-CTP-Ⅲa
Status last verified
Dec 2019
First submitted
13 Mar 2018
Last updated
22 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Song H, Wang Y, Ma Q, Feng W, Liu R, Lv X, Huang L, Li Y, Yang Y, Geng D, Zhu J, Wei Y, Chen H, Zhu R, Zhai Q, Guo J, Liu B, Zhao S, Wang Y; PROST collaborative group. Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Ischemic Stroke Within 4.5 Hours of Stroke Onset: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2325415. doi: 10.1001/jamanetworkopen.2023.25415.

    PubMed 37490291

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant human urokinase and Alteplase in people with Acute Ischaemic Stroke, run by Tasly Biopharmaceuticals Co., Ltd. at 35 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 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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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?

Functional handicap (time frame: 90days). 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 NCT03541668, 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 22 Jun 2020.

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