Skip to content

Efficacy and safety evaluation of agatreban in combination with dual antiplatelet aggregation for hyperthrombolytic watershed cerebral infarction: a multicenter, prospective, open-label randomized controlled clinical trial

Efficacy and safety evaluation of agatreban in combination with dual antiplatelet aggregation for hyperthrombolytic watershed cerebral infarction: a multicenter, prospective, open-label randomized controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045812
Enrollment
Unknown
Registered
2021-04-25
Start date
2021-05-17
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Watershed cerebral infarction

Interventions

Group A:Agatreban and dual antiplatelet group
Group B:Dual antiplatelet group
Group C:argatroban group

Sponsors

Affiliated Hospital of Jiujiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with acute ischemic stroke within 0-48 hours of onset; 2. Not suitable for or refuse thrombolysis or endovascular treatment; 3. Aged 40 to 75 years; 4. Baseline NIHSS score 1-8 points; 5. After admission, MRI/DWI/CTA was diagnosed as watershed cerebral infarction (responsible for large artery stenosis with or without occlusion), and magnetic sensitivity (SWI or T2*) showed = 1.5 T; 7. The patient and the legal representative are able and willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are serious neurological deficits (mRS>=2) before the onset; 2. Within 3 months before admission, have a craniocerebral injury or undergo intracranial or intraspinal surgery, or have a history of intracranial hemorrhage and stroke, intracranial tumor, moyamoya disease, arteriovenous malformation or aneurysm; 3. Received major surgery or severe trauma within 1 month before admission, or had gastrointestinal or urethral bleeding; had an incompressible arterial puncture within 1 week before admission; 4. Active bleeding disease, with obvious bleeding tendency (obvious coagulation dysfunction); abnormal coagulation function (PLT 1.7, aPTT > 40s, or PT > 15s), coagulation factor Lack of patients 5. After blood pressure control, the systolic blood pressure is still >= 220mmHg or the diastolic blood pressure is still >= 120mmHg; 6. Cardiogenic embolism, valvular heart disease, atrial fibrillation, sick sinus, second to third degree atrioventricular block; 7. Those who need to take anticoagulant drugs other than argatroban at the same time, or those who have used anticoagulant drugs in the past week; 8. Those who are allergic to argatroban; 9. Pregnancy or lactation; 10. Those who are contraindicated in the use of aspirin or clopidogrel; (1) Aspirin is forbidden: allergic to aspirin or other salicylates, or any other ingredients of medicines; history of asthma caused by salicylate or salicylic acid substances, non-steroidal anti-inflammatory drugs; acute gastrointestinal ulcers; Bleeding constitution; severe renal failure; severe liver failure; severe heart failure; combined with methotrexate, the last trimester of pregnancy; (2) Clopidogrel is forbidden: allergic to clopidogrel or any component of the preparation, severe liver damage, active pathological bleeding, or digestive tract ulcer or intracranial hemorrhage) 11. Watershed infarction caused by other special reasons: bilateral watershed cerebral infarction caused by systemic hypotension or global cerebral hypoperfusion, severe anemia, eosinophilia, parasitic infection, toxicity caused by cyclosporine treatment, primary Central nervous system vasculitis, autosomal dominant cerebral arterial disease (CADASIL) with subcortical infarction and leukoencephalopathy, and watershed cerebral infarction caused by malignant-associated coagulopathy; 12. MRI confirmed patients with multiple intracranial microhemorrhage (CMBs>=10) or cerebrovascular amyloidosis; 13. Severe systemic diseases, such as severe heart, lung, liver, and kidney failure; 14. Participating in other studies that have an impact on this research; 15. The investigator assesses other situations that are not suitable for participating in this drug study (such as dementia, combined mental or mental illness, etc.).

Design outcomes

Primary

MeasureTime frame
The incidence of progressive cerebral infarction within 1 week after randomization;

Countries

China

Contacts

Public ContactYin Xiaoping

Affiliated Hospital of Jiujiang University

xiaopingbuxiao@126.com+86 13870218146

Outcome results

None listed

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