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Argatroban combined with clopidogrel and aspirin in preventing early neurological deterioration in patients with acute penetrating artery infarction:a prospective multicenter randomized controlled trial

Argatroban combined with clopidogrel and aspirin in preventing early neurological deterioration in patients with acute penetrating artery infarction:a prospective multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046487
Enrollment
Unknown
Registered
2021-05-16
Start date
2021-05-15
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

penetrating artery infarction (acute ischemic stroke)

Interventions

experimental group:Argatroban combined with dual antiplatelet (argatroban+clopidogrel+aspirin)
control group:Dual antiplatelet (clopidogrel+aspirin)

Sponsors

Chengdu Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Mild stroke: NIHSS score = 10mm, number of layers >= 3; (2) Subpontine infarction: the lesion needs to extend to the ventral side of the pons; (3) Posterior type of pipeline artery; (4) Multiple infarcts in perforator distribution area; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. mRS scores >= 1 before the onset; 2. A history of non-traumatic intracranial hemorrhage; 3. A history of severe head trauma or stroke in the past 3 months; 4. The patient should have received intravenous thrombolysis, or arterial thrombolysis or mechanical thrombolysis within 24 hours; 5. The stenosis of the intracranial and extracranial large arteries on the same side of the infarct lesion is >= 50%; 6. Cortical or watershed infarction; 7. Images suggest a high risk of bleeding: such as severe white matter lesions (Blennow score 3 points or Fazekas score 3 points), multiple lacunar infarctions, or lacunar states; 8. Clopidogrel or ASA contraindications: including allergies, severe renal insufficiency or liver insufficiency, history of thrombocytopenia or platelet count < 100 x 10 9/L, history of coagulopathy or systemic bleeding; 9. Taking anticoagulant drugs; 10. A history of atrial fibrillation/atrial flutter or artificial heart valve, suggesting that anticoagulation treatment is required during the study period; 11. Gastrointestinal bleeding, urinary system bleeding, or major surgical operations in the past 3 months; 12. Women in menstruation or pregnancy; 13. Severe cardiac insufficiency, malignant tumor or asthma; 14. Insertion of a pacemaker or other contraindications for magnetic resonance examination; 15. Participating in other clinical research.

Design outcomes

Primary

MeasureTime frame
early neurological deterioration in 7 days;good prognosis after 3 months;

Secondary

MeasureTime frame
new clinical vascular events;Changes of NIHSS scores in 3 months;disability risk;quality of life;mental state;Safety;

Countries

China

Contacts

Public ContactWang Jian

Chengdu Second People's Hospital

42523748@qq.com+86 18908178049

Outcome results

None listed

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