Health TrialsbyHealthPanel

Pro-urokinase for Extended-Window Posterior Circulation Stroke

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

This study aims to evaluate whether, in patients with imaging-confirmed acute ischemic stroke of the posterior circulation presenting within 4.5-24 hours after symptom onset and not scheduled for endovascular thrombectomy, intravenous thrombolysis with recombinant human prourokinase (rhPro-UK), compared with standard medical treatment, can achieve superior 90-day functional outcomes with a higher level of safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);

DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;

DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;

Disqualifiers

Planned endovascular treatment;

Contradictory to MRI examination;

MRI image not qualified for evaluation;

Serious neurological deficits before onset (mRS≥2);

Trial design

Design model

Parallel

Treatments tested in this trial

  • rhPro-UK

    Drug

    rhPro-UK (5 mg/vial), to maximum of 35mg

  • placebo

    Drug

    Asprin (placebo)

  • Aspirin

    Drug

    Asprin (300mg)

  • Placebo

    Drug

    rhPro-UK(placebo)

Treatment groups

586 Participants
are divided into 2 treatment groups
Group A: rhPro-UK groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Modified Rankin Scale (mRS)

Proportion of subjects of excellent outcome defined as mRS (0-1) at 90 ± 7 days.

Time frame
90 ± 7 days]

Secondary outcomes

1

Modified Rankin Scale (mRS)

Proportion of subjects of excellent outcome defined as mRS (0-2) at 90 ± 7 days.

Time frame
90 ± 7 days
2

Modified Rankin Scale (mRS)

Ordinal shift analysis of mRS at 90 days

Time frame
90 ± 7 days
3

National Institutes of Health Stroke Scale (NIHSS)

NIHSS change from baseline at 24 hours and 7 days.

Time frame
24 hours and 7 days
4

Barthel (BI)

Barthel Index score at 90 ± 7 days.

Time frame
90 ± 7 days

Other outcomes

1

Symptomatic intracranial hemorrhage (sICH)

Proportion of subjects with symptomatic intracranial hemorrhage (sICH) at 36 hours (according to the ECASS III criteria).

Time frame
36 hours
2

Death

Overall mortality rate at 90 days.

Time frame
90 days
3

Systemic bleeding

Systemic bleeding at 90 days (according to the GUSTO criteria)

Time frame
90 days
4

Adverse events (AEs)/ serious adverse events (SAEs)

Proportion of patients with adverse events (AEs)/ serious adverse events (SAEs) within 90 days.

Time frame
90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Zhengzhou University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: