Using Shuxuening Injection to enhance treatment for ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Shuxuening injection as a neuroprotective agent in patients undergoing intravenous thrombolysis for acute ischemic stroke. A total of 1380 patients will be enrolled from 50 centers in China, all of whom must be treated within 6 hours of stroke onset. Participants will be randomly assigned to receive either the Shuxuening injection or a placebo for a duration of 10-14 days. The primary outcomes will assess functional recovery and safety through mRS scores and adverse events within 90 days.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 or older;
* Diagnosed with acute ischemic stroke;
* Within 6 hours of onset;
* Having received or plan to undergo intravenous thrombolytic therapy;
* NIHISS score of 4 to 25 points at enrollment;
* Signed informed consent.

Exclusion Criteria:

* mRS score greater than 1 point before the onset;
* Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset;
* Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by CT/MRI;
* History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
* Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the ALT or AST levels above 3 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 times the upper limit of normal);
* Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract);
* Women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures;
* Participation in another clinical trial with an experimental product during the last 30 days;
* Other participants deemed unsuitable for participation in this study by the investigator.

Where it's running

• Fangshan District First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Chongqing Nanchuan District People's Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Chongqing Sanbo Chang'an Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Chongqing Qianjiang Central Hospital
  Qianjiang, Chongqing Municipality, China Recruiting
• The First Affiliated Hospital of Guangdong Pharmaceutical University
  Guangzhou, Guangdong, China Recruiting
• Heyuan People's Hospital
  Heyuan, Guangdong, China Recruiting

+32 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Anxin Wang
• Email: anxin0907@163.com
• Phone: +86 1059975806

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-powered decision support to boost thrombolysis for ischemic stroke

  This trial tests whether an AI-assisted decision tool helps doctors give intravenous thrombolysis to eligible ischemic stroke patients within 24 hours at a primary hospital in China, compared with standard care.

  Recruiting Capital Medical University · Changsha, Hunan · NCT07785492

• Tegoprazan to prevent GI complications in ischemic stroke patients on antiplatelet therapy

  This trial tests whether tegoprazan can lower gastrointestinal complications in adults with ischemic stroke or TIA who are starting antiplatelet therapy.

  Recruiting at 24 sites Phase 3 Hanyang University · Busan, Busan and 23 other locations · NCT07687706

• Intra-arterial Thrombolysis for Acute Ischemic Stroke with Medium Vessel Occlusion

  This trial tests whether delivering a clot-busting medicine directly into the brain’s medium vessels helps improve outcomes for adults with acute ischemic stroke caused by MeVO, on top of standard care.

  Recruiting Phase 3 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07668323

• Single Bolus Non-immunogenic Staphylokinase in Acute Ischemic Stroke (4.5–24 hours)

  This trial tests a single 10 mg bolus of non-immunogenic staphylokinase versus placebo in adults with acute ischemic stroke 4.5–24 hours after onset to see if it helps restore blood flow and improve outcomes.

  Recruiting at 10 sites Phase 3 Supergene, LLC · Ryazan, Ryazan Oblast and 16 other locations · NCT07324837

• Imaging to detect impaired microcirculatory reperfusion after clot removal

  This project tests whether CT perfusion scans done after clot removal can spot poor tiny-vessel blood flow in adults with large-vessel ischemic stroke.

  Recruiting University of Cincinnati · Cincinnati, Ohio · NCT07099599

• Cerebrolysin for early rehabilitation after acute ischemic stroke

  This trial tests whether adding Cerebrolysin to standard early rehabilitation helps people with moderate acute ischemic stroke recover arm and overall function faster.

  Recruiting University Medical Centre Ljubljana · Ljubljana · NCT07043686

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.