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New clot-busting drug could improve stroke recovery in major trial

NCT ID NCT06658197

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a newer clot-dissolving drug (tenecteplase) works better than the standard drug (alteplase) when given before a mechanical procedure to remove a large blood clot from the brain. About 850 adults who have had a severe stroke within the last 4.5 hours will be randomly assigned to receive one of the two drugs. The main goal is to see if more people recover with little or no disability 90 days after treatment.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 850 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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 is ≥18 years. 2. AIS symptom onset ≤4.5 hours, onset time refers to the time the patient was last known to be well. (Recommendation time from thrombolysis to puncture within 60 minutes). 3. Arterial occlusion of the internal carotid artery (ICA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery on computed tomography angiography (CTA) or magnetic resonance angiography (MRA). 4. Prestroke mRS score ≤2. 5. Informed consent from the patient or legally authorised representative. Exclusion Criteria: 1. Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.) or other related conditions identified by CT. 2. Contraindication to imaging examinations involving contrast agent injection. 3. Patients presenting with clinical symptoms of coma (NIHSS Score Item 1a = 3). 4. History of intracranial hemorrhage. 5. History of severe head trauma or stroke within the past 3 months. 6. Intracranial or intraspinal surgery within the past 3 months. 7. Major surgery within the past 2 weeks. 8. Gastrointestinal or urinary tract bleeding within the past 3 weeks. 9. Intracranial tumor, arteriovenous malformation, or giant intracranial aneurysm. 10. Active visceral bleeding. 11. Aortic arch dissection. 12. Arterial puncture at a non-compressible site within the past week. 13. Uncontrolled hypertension despite active antihypertensive treatment: Systolic Blood Pressure \> 180 mmHg or Diastolic Blood Pressure \> 100 mmHg. 14. Acute hemorrhagic tendency, including platelet count \< 100 × 10⁹/L or other conditions. 15. Heparin treatment received within the past 24 hours. 16. For patients on oral anticoagulants: INR \> 1.7 or PT \> 15 seconds. 17. Use of direct thrombin inhibitors or direct Factor Xa inhibitors within the past 48 hours. 18. Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L. 19. Hypodensity affecting \> 1/3 of the middle cerebral artery territory or an equivalent proportion of the basilar artery territory on non-contrast CT. 20. Rapidly improving symptoms as determined by the investigator. 21. Participation as a subject in another research study within the past 30 days. 22. Any terminal illness where life expectancy is considered not to exceed 1 year. 23. Any condition where, in the judgment of the investigator, the study treatment might pose a risk to the patient or affect the patient's participation in the study. 24. Pregnant women. 25. Known allergy to the active ingredients (Alteplase, Tenecteplase) or any excipients.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.