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The clinical trial of argatroban for the prevention of early neurological deterioration in acute ischemic stroke: multicenter, prospective, open-label, endpoint-blinded, randomized controlled phase 2 clinical trial

The prevention value of argatroban for early neurological deterioration in acute ischemic stroke: a multicenter, prospective, open-label, endpoint-blinded, randomized controlled phase 2 clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110858
Enrollment
Unknown
Registered
2025-10-21
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Ischemic stroke

Interventions

Agacurtan Group (Experimental group):The argatroban group was treated with argatroban combined with aspirin. After enrollment, argatroban injection was administered for 7 days (continuous intravenous
intravenous drip at a dose of 10 mg every 12 hours for the next 5 days, with the infusion time exceeding 3 hours). The aspirin regimen was the same as that in the control group.
Control group:Take oral aspirin 150 mg/d within 14 days after enrollment, and 100 mg/d from 15 to 90 days.

Sponsors

Shantou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) 18 to 80 years old; 2) The onset time of symptom or the last known time of normal was within 4.5 to 48 hours for acute cerebral infarction; 3) NIHSS score: 4 to 10, and the affected limb muscle strength was not completely paralyzed (NIHSS item 5 (upper limb movement) and item 6 (lower limb movement) score <= 3 ); 4) no severe stenosis (degree of stenosis 70 - 99%) or occlusion of large or medium-sized intracranial vessels were showed in CTA or MRA; 5) The patient or the legal representative signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Etiology judged as cardiogenic embolism or probable cardiogenic embolism by trained evaluators; 2) Undergoing or planned to undergo endovascular mechanical thrombectomy; 3) Receiving tirofiban therapy 4) Cerebral hemorrhage, brain abscess, or intracranial space-occupying lesions detected by CT; 5) ASPECTs score 1.5; 14) Platelet count = 2; 16) According to the investigator's judgment, concurrent use of anticoagulants other than argatroban (i.e., during argatroban infusion) is anticipated; 17) Active peptic ulcer or bleeding; 18) Allergy to aspirin or argatroban; 19) Life expectancy < 3 months; 20) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Early neurological deterioration within 7 days after randomization and enrollment ;

Secondary

MeasureTime frame
The improvement degree of the 90-day mRS score;The proportion of patients with mRS score of 0 to 1 within 90 days;The proportion of patients with mRS score of 0 to 2 within 90 days;

Countries

China

Contacts

Public ContactHuang Chuming

Shantou Central Hospital, Department of Neurology, Cerebrovascular Ward Area

huangcmst@163.com+86 137 1597 6150

Outcome results

None listed

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