Can a smarter blood pressure approach make stroke Clot-Busting safer?
NCT ID NCT07279259
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to manage blood pressure in people having a stroke who receive clot-busting medication. The goal is to see if adjusting blood pressure treatment can lower the risk of bleeding in the brain. About 340 participants will be randomly assigned to either the new or standard blood pressure approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adjusted blood pressure management procedure
- What this could lead to
- If successful, this could lead to a safer way to manage blood pressure during stroke treatment, potentially reducing the risk of brain bleeding.
- What could go wrong
- This is an early Phase 2 trial with only 340 participants, so results may not apply to all stroke patients. The new strategy might not lower bleeding risk and could even increase other complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 to 80 years (inclusive); 2. Patients with acute ischemic stroke; 3. Planned to receive intravenous thrombolysis within 4.5 hours of onset; 4. Elevated blood pressure: Before receiving intravenous thrombolysis treatment, blood pressure is elevated: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg (defined as two consecutive measurements within 2 minutes); 5. Informed consent signed (or signed by a proxy). Exclusion Criteria: 1. Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma). 2. History of intracranial hemorrhage; severe head trauma or stroke within the last 3 months. 3. Intracranial tumors, giant intracranial aneurysms. 4. Intracranial or spinal surgery within the last 3 months; major surgery within the last 2 weeks; arterial puncture at a site not easily compressed for hemostasis within the last 7 days. 5. Gastrointestinal or urinary system bleeding within the last 3 weeks. 6. Aortic dissection. 7. Acute bleeding tendency, including platelet count \< 100×10\^9/L or other bleeding tendencies. 8. Received low-molecular-weight heparin orally within 24 hours; taking warfarin with INR \> 1.7 or PT \> 15 seconds; used a new oral anticoagulant within 48 hours. 9. Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L. 10. Large area cerebral infarction indicated on head CT or MRI (infarction area \> 1/3 of the middle cerebral artery territory). 11. Active visceral hemorrhage, known bleeding diathesis or significant bleeding disorders within the past 6 months 12. Severe ischemic stroke (NIHSS score \> 25) 13. Epileptic seizures at the time of stroke onset 14. Pregnant or lactating women 15. Various terminal diseases with an expected survival of ≤ 3 months 16. Any other physical conditions where the doctor deems participation in this study may be detrimental to the patient 17. Currently participating in other drug or device clinical trials 18. mRS score \> 2 before onset of the disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai East Hospital
RECRUITINGShanghai, China
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