Intravenous Thrombosis and Patients with Prior Ischemic Stroke Within 3 Months

NCT06841978 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: TIPS
• Study Type: interventional
• Target: 306
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

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

  90 ± 7 days

Secondary Outcomes (7)

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

  90 ± 7 days

• recovery assessed by modefied Rankin Scale (mRS) score

  90 ± 7 days

• 3-month mortality

  90 ± 7 days

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

  at day 1

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

  at day 1

Study Arms (2)

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

EXPERIMENTAL

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).

Drug: Intravenous Thrombolysis

Standard therapy

NO INTERVENTION

Standard therapy

Interventions

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with prior ischemic stroke within 3 months
• Patients ≥ 18 years old
• Informed consent has been obtained depending on local ethics requirements.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Min Lou, PhD, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Lou

CONTACT

PhD, MD; lm99@zju.edu.cn

Wansi Zhong, MD

CONTACT

8618757155806; 21718233@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 24, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share