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Sanchitongtshu capsule plus Aspirin vs. Aspirin alone therapy for acute ischemic stroke: a multicenter, randomised, double-blind, placebo-controlled clinical trial

Sanchitongtshu capsule plus Aspirin vs. Aspirin alone therapy for acute ischemic stroke: a multicenter, randomised, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022495
Enrollment
Unknown
Registered
2019-04-13
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. The first onset acute ischemic stroke with 4?=NIHSS=15?; 3. Symptom onset within 72 hours; 4. The studying medicine can be applied with 72 hours of symptom onset; 5. Patients or their legal representatives will be able to sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. History of intracranial hemorrhagic disease, such as cerebral hemorrhage, subarachnoid hemorrhage, etc; 2. Other identified intra-cerebral pathological disorders on baseline CT or MRI of head, such as: cerebral vascular malformation, tumor, non-ischemic stroke diseases (like multiple sclerosis); History of aneurysm (including intracranial aneurysms, peripheral artery aneurysms); 3. Moderate or severe ischemic stroke caused by angioplasty, cerebral vascular stent, carotid endarterectomy; 4. mRS score is more than two points; 5. Ischemic stroke patients with cardiac embolism causes, such as atrial fibrillation, atrial myxoma disease; Diagnosed with acute coronary syndrome; 6. Patients with hemorrhagic disorder, such as coagulation disorders, systemic hemorrhage, thrombocytopenia history; 7. Patients have any type of major surgery before 30 days of randomization, or plan to have any angioplasty or vascular surgery within 3 months after randomization; 8. Patients with medical contraindication for aspirin: such as severe liver and kidney function disorder; Patients need long-term (>7 days) use of non-steroidal anti-inflammatory drugs during the study period; Gastrointestinal bleeding disorder; 9. Patients need to take other antithrombotic therapy during the study, including antiplatelet medications (e.g., clopidogrel, GPIIb/IIIa inhibitors, ticagrelor, prasugrel, dipyridamole, ozagrel, silotrazole, etc.) and anticoagulant medications (such as warfarin, thrombin and factor Xa inhibitors, argatroban, heparins or low molecular weight heparins, etc.); 10. Blood pressure is lower than 90 mmHg / 60 mmHg or higher than 220 mmHg / 120 mmHg even after treatments to adjust blood pressure; Have severe cardiac or pulmonary disorders, or other diseases that researchers believe are not appropriate for this study; 11. Allergy to ingrediants of the studying drugs; 12. Life expectancy of patients is less than 3 months or for some identified reasons that make them cant complete the study; 13. Life expectancy of patients is less than 3 months or for some identified reasons that make them cant complete the study; 13. Women are in period of pregnancy or lactation; or women of childbearing age have negative pregnancy test at randomization, but refuse to use effective contraception measures; 14. Patients participate in other clinical trials of drugs or medical devices within 30 days of randomization; 15. Patients can't understand or subject to the research program and follow-up because of mental disorders, cognitive impairment or emotional problems.

Design outcomes

Primary

MeasureTime frame
mRS;

Secondary

MeasureTime frame
recurrent cardiocerebrovascular events at 3 months;proportion of recurrent ischemic stroke at 3 months;EQ-5D-3L;HAMA/HAMD;MMSE;BI;hemorrhage events;mortality;NIHSS;

Countries

China

Contacts

Public ContactHe Li

West China School of Medicine, Sichuan University

heli2003new@126.com+86 18980601670

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026