Intravenous Thrombosis and Patients with Prior Ischemic Stroke Within 3 Months

NCT ID: NCT06841978

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Stroke; Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intravenous thrombolysis (alteplase and other guideline-recommended thrombolytic agents) )

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).

Group Type: EXPERIMENTAL

Intravenous Thrombolysis

Intervention Type: 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).

Standard therapy

Standard therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intravenous Thrombolysis

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

2. Patients with prior ischemic stroke within 3 months

3. Patients ≥ 18 years old

4. 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：

1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.)

2. Previous history of intracranial hemorrhage

3. Severe head trauma or stroke history within the last 3 months

4. Intracranial tumors, giant intracranial aneurysms

5. Intracranial or spinal surgery within the recent 3 months

6. Major surgical procedures within the last 2 weeks

7. Gastrointestinal or urinary tract bleeding within the last 3 weeks

8. Active visceral bleeding

9. Aortic arch dissection

10. Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding

11. Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg

12. Acute bleeding tendency, including platelet count < 100 × 10⁹/L or other conditions

13. Received low-molecular-weight heparin treatment within 24 hours

14. 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.

15. Blood sugar < 2.8 or > 22.22 mmol/L

16. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Lou, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Central Contacts

Min Lou

Role: CONTACT

lm99@zju.edu.cn

PhD, MD ext. 8613958007213

Wansi Zhong, MD

Role: CONTACT

21718233@zju.edu.cn

8618757155806

Other Identifiers

TIPS

Identifier Type: -

Identifier Source: org_study_id