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NCT Number: NCT06841978

Intravenous Thrombosis and Patients with Prior Ischemic Stroke Within 3 Months

The primary hypothesis being tested in this trial is that ischemic stroke patients with prior ischemic stroke within 3 months will have improved clinical outcomes when given intravenous thrombolysis compared to standard care.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with clinical signs of acute ischemic stroke within 24 hours of onset or awakening with stroke (if within 24 hours from the midpoint of sleep). Patients with AIS within 4.5-24 hours of onset must meet the IVT inclusion criteria specified in the guideline
  • Patients with prior ischemic stroke within 3 months
  • Patients ≥ 18 years old
  • Informed consent has been obtained depending on local ethics requirements.

Exclusion criteria

(1) Plan to receive endovascular treatment (2) Pre-stroke mRS score > 2 (3) Contraindications for IVT:

  • Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.)
  • Previous history of intracranial hemorrhage
  • Severe head trauma or stroke history within the last 3 months
  • Intracranial tumors, giant intracranial aneurysms
  • Intracranial or spinal surgery within the recent 3 months
  • Major surgical procedures within the last 2 weeks
  • Gastrointestinal or urinary tract bleeding within the last 3 weeks
  • Active visceral bleeding
  • Aortic arch dissection
  • Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding
  • Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg
  • Acute bleeding tendency, including platelet count < 100 × 10⁹/L or other conditions
  • Received low-molecular-weight heparin treatment within 24 hours
  • Oral anticoagulants (warfarin) with INR > 1.7 or PT > 15 s; Receiving heparin treatment with aPTT above the upper limit of the normal range within the last 24 hours of onset, Receiving thrombin inhibitors and factor Xa inhibitors within the last 48 hours of onset.
  • Blood sugar < 2.8 or > 22.22 mmol/L
  • Head CT or MRI indicates large-area infarction (infarction area ≥ 1/3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator

Treatment and study plan

Intravenous thrombolysis

Drug

Patients will receive standard dose intravenous alteplase (0.9 mg/kg, the first 10% administered as an initial bolus and the remainder over a 1-hour period, with a maximum dose of 90 mg),intravenous Tenecteplase(0.25mg/kg,administered as a single intravenous bolus injection over 5 - 10 seconds,with a maximum dose of 25 mg), intravenous reteplase (a bolus of 18 mg followed by a second bolus of 18 mg after 30 minutes) and intravenous prourokinase (rhPro-UK) (15 mg bolus followed by a 20 mg infusion over 30 minutes).

Primary outcomes

  1. Independent recovery assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days

    Time frame: 90 ± 7 days

    mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

Secondary outcomes

  1. Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days

    Time frame: 90 ± 7 days

    mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

  2. recovery assessed by modefied Rankin Scale (mRS) score

    Time frame: 90 ± 7 days

    mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

  3. 3-month mortality

    Time frame: 90 ± 7 days

    Hospitalization records or follow-up results

  4. Presence of parenchymal hemorrhage (PH) evaluated by CT or MRI

    Time frame: at day 1

    the presence of PH is defined according the standard from ECASS-2 study

  5. Presence of symptomatic intracerebral hemorrhage (sICH) evaluated by CT or MRI

    Time frame: at day 1

    the presence of sICH is defined according the standard from ECASS-2 study

  6. Presence of hemorrhagic transformation evaluated by CT or MRI

    Time frame: at day 1

    Presence of hemorrhagic transformation is defined according the standard from ECASS-2 study

  7. the change on the NIHSS score from baseline to 24 hours

    Time frame: 24 hours

    NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou

CONTACT

[email protected]

PhD, MD ext. 8613958007213

Wansi Zhong, MD

CONTACT

[email protected]

8618757155806

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Intravenous Thrombosis in Acute Ischemic Stroke Patients with Prior Ischemic Stroke Within 3 Months

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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