A Randomized Controlled Study on Tirofiban Combined with Nimodipine for Early Neurological Deterioration in Small Artery Occlusive Cerebral Infarction

A Randomized Controlled Trial on the Efficacy and Safety of Tirofiban Combined with Nimodipine in the Treatment of Early Neurological Deterioration in Small Artery Occlusive Cerebral Infarction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500105760

Enrollment

Unknown

Registered

2025-07-10

Start date

2025-08-04

Completion date

Unknown

Last updated

2025-07-14

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

Conditions

Small Artery Occlusive Cerebral Infarction

Interventions

Monotherapy group:Tirofiban (loading dose: 0.4 µg/kg/min

Combination therapy group:Tirofiban (loading dose: 0.4 µg/kg/min

maintenance infusion: 0.1 µg/kg/min for 48 hours) combined with Nimodipine (continuous infusion: 2 mg/h via syringe pump for 48 hours).Plus standard care: All patients received guideline-recommended b

maintenance infusion: 0.1 µg/kg/min for 48 hours) . Plus standard care: All patients received guideline-recommended best medical therapy, including antiplatelet agents, blood pressure control, lipid-l

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years. (2) Acute small artery occlusive cerebral infarction (meeting diagnostic criteria from the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023). (3) Measurable neurological deficit on NIHSS (0 =2 points or motor score increase >=1 point), with pre-trial NIHSS motor item score of 1–4 in at least one limb (scale: 0–4; higher scores indicate worse motor strength). (5) Culprit lesion on DWI showing subcortical deep infarction <=2 cm in diameter, without corresponding severe stenosis or occlusion of large-to-medium arteries. (6) Pre-stroke mRS score 0–1. (7) Voluntary provision of written informed consent.

Exclusion criteria

Exclusion criteria: (1) Culprit large-to-medium artery stenosis >=70% or evidence of cardioembolism. (2) Severe hepatic/renal dysfunction (eGFR 1.4). (4) Pregnancy. (5) History of intracranial hemorrhage, intracranial tumor, or movement disorders. (6) Active suicidality (suicidal ideation within 6 months; suicide attempt within 2 years; or >=2 lifetime suicide attempts). (7) Psychiatric disorders requiring psychotropic medication. (8) Any condition compromising study participation or patient safety. (9) Other factors potentially confounding study results (e.g., substance abuse, hazardous occupational exposures).

Design outcomes

Primary

Measure	Time frame
Early Neurological Improvement ;	—

Secondary

Measure	Time frame
90-Day Excellent Functional Outcomes;	—

Countries

China

Contacts

Public ContactFeng Xiaopeng

Xiushan Tujia and Miao Autonomous County People's Hospital

xiaopengfeng0707@163.com+86 191 3278 0280

Outcome results

None listed

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