Clinical trial · Interventional
Intravenous Thrombolysis in Acute Ischemic Stroke with Active Cancer
Th Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke with Cancer
NCT06841965CI-TRIAL-00086352not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary hypothesis being tested in this trial is that ischemic stroke patients with active cancer will have improved clinical outcomes when given intravenous thrombolysis compared to standard care.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Ischemic Stroke | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous thrombolysis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intravenous thrombolysis (alteplase and other guideline-recommended thrombolytic agents))
- description
- 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).
- interventionNames
- Drug: Intravenous thrombolysis
- type
- NO_INTERVENTION
- label
- Standard therapy
- description
- Standard therapy
Primary outcomes (1)
- measure
- Independent recovery assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. Patients with active cancer (Active cancer was defined as cancer diagnosed within the previous 6 months; recurrent, regionally advanced or metastatic cancer, or cancer for which treatment had been administered within 6 months, or haematological cancer without complete remission.) 3. Patients ≥ 18 years old 4. Informed consent has been obtained depending on local ethics requirements. Exclusion Criteria: (1) Intended to proceed to 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
References
Publications (0)
Data not yet available
No reference posted for this study.