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Acute Ischaemic StrokePhase 3PROUDNCT03578822

Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial

A Phase 3 study testing Recombinant human urokinase, Aspirin and rhPro-UK simulation agent in people with Acute Ischaemic Stroke, run by Tasly Biopharmaceuticals Co., Ltd. at 19 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,controlled, double-blinded, phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus basic treatment for patients with acute ischaemic stroke in 4.5-6 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, Aspirin and rhPro-UK simulation agent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
19 sitesChina
Study dates
10 Aug 2018to 1 Mar 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,male or famale.
  • NIH Stroke Scale（NIHSS）scores of 4 to 25.
  • Treatment 4.5 to 6 hours after stroke onset.(Stroke onset time is defined as the last time a patient with no clinical neurological deficit,for patients who wake up with stroke symptoms, consider that stroke occurs when the patient begins to fall asleep).
  • The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
  • CT showed negative or signs of early infarction.
  • Patients and/or their families are willing to participate in this study and agree to sign informed consent.

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 when stroke onset.
  • Intracranial tumor, arteriovenous malformation and aneurysm.
  • Iatrogenic Stroke.
Show all 26Show fewer
  • Thrombectomy is planned.
  • Cardioembolism and atrial fibrillation.
  • Myocardial infarction history within 3 months.
  • Severe cerebral trauma or stroke history within 3 months.
  • Blood pressure is still out of control after aggressive antihypertensive treatment.Uncontrolled blood pressure is defined as systolic blood pressure≥ 180mmHg or diastolic blood pressure≥100mmHg.
  • High density lesions (bleeding) and subarachnoid hemorrhage is revealed by emergency CT examination.
  • 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 48 hours (APTT above normal upper limit).
  • Taking anticoagulant drugs orally, and PT >15s or INR >1.7.
  • High risk of acute hemorrhage include platelet count<10^9/L.
  • Taking thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination(e.g. APTT, INR, PLT, FIB、TT or appropriate Ⅹ a factor activity test, etc.).
  • Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
  • Pregnancy, lactating or menstrual women.
  • Patients who have difficulty swallowing and are unable to take medications orally.
  • Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Baotou Central Hospital

    Baotou, Inner Mongolia

  • First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia

  • XuanWu Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • First Hospital of Jilin University

    Changchun, Jilin

  • Dalian Municipal Central Hospital

    Dalian, Liaoning

  • 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

  • Luoyang Central Hospital

    Luoyang, Zhengzhou

  • Meihekou Central Hospital

    Meihekou, Jilin

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • Shenyang Military Region General Hospital

    Shenyang, Liaoning

  • The First People's Hospital of Shenyang

    Shenyang, Liaoning

  • Tangshan Gongren Hospital

    Tangshan, Hebei

  • 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 4.5-6 Hours After Stroke Onset

This is a randomized,controlled, double-blinded, phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus basic treatment for patients with acute ischaemic stroke in 4.5-6 hours after stroke onset.

Being tested
Recombinant human urokinase, Aspirin, rhPro-UK simulation agent, Aspirin simulation agent

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 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.

  • AspirinDrug

    Aspirin 300mg is taken orally at the beginning of thrombolysis.

  • rhPro-UK simulation agentDrug

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

  • Aspirin simulation agentDrug

    Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis.

Study groups in NCT03578822
Study groupRoleWhat they receive
Group AExperimentalRecombinant human urokinase(rhPro-UK) and Aspirin simulation agent
Receives: Drug: Recombinant human urokinase; Drug: Aspirin simulation agent
Group BOtherrhPro-UK simulation agent and Aspirn
Receives: Drug: Aspirin; Drug: rhPro-UK simulation agent

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 (11)

  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. Index Long-term Change from Baseline of Barthel Index

    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. Long-term Change from Baseline of NIHSS

    NIHSS changes from baseline on 90 days after treatment.

    Measured: 90 days

  5. Long-term Change from Baseline of mRS

    mRS changes from baseline on 90 days after treatment.

    Measured: 90 days

  6. Proportion of Long-term Improvement

    Proportion of patients achieving a mRS of 0 to 2 at 90 days after treatment.

    Measured: 90 days

  7. Proportion of Long-term Improvement

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

    Measured: 90 days

  8. Systemic hemorrhage

    Severe systemic hemorrhage

    Measured: 90days

  9. Symptomatic intracerebral hemorrhage

    Symptomatic intracerebral hemorrhage (sICH)

    Measured: 90days

  10. Death

    Death

    Measured: 7 days and 90 days

  11. Recurrence

    Recurrence of stroke

    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 posted6 Jul 2018
  2. Study start10 Aug 2018
  3. Primary completion28 Feb 2020
  4. Study completion1 Mar 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03578822
Sponsor's protocol ID
TASLY-B1440-CTP-Ⅲb
Acronym
PROUD
Status last verified
Apr 2020
First submitted
20 Jun 2018
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant human urokinase, Aspirin and rhPro-UK simulation agent in people with Acute Ischaemic Stroke, run by Tasly Biopharmaceuticals Co., Ltd. at 19 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 26 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 NCT03578822.

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 28 Apr 2020.

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