NCT06841978Not yet recruitingPhase 3
Intravenous Thrombosis and Patients with Prior Ischemic Stroke Within 3 Months
Intravenous Thrombosis in Acute Ischemic Stroke Patients with Prior Ischemic Stroke Within 3 Months
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 306 (estimated)
- First submitted
- 20 Jan 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Stroke
- NCT number
- NCT06841978
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 306
- From 1 Mar 2025 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of intracranial hemorrhage
- Intracranial or spinal surgery within the recent 3 months
- Major surgical procedures within the last 2 weeks
- Received low-molecular-weight heparin treatment within 24 hours
Other illness
- (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.)
- Severe head trauma or stroke history within the last 3 months
- Gastrointestinal or urinary tract bleeding within the last 3 weeks
- Active visceral bleeding
- Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding
Lab values
- Acute bleeding tendency, including platelet count \< 100 × 10⁹/L or other conditions
- 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
Other
- Intracranial tumors, giant intracranial aneurysms
- Aortic arch dissection
- Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.