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An exploratory single-arm trial of tirofiban adjuvant therapy after intravenous thrombolysis with reteplase

An exploratory single-arm trial of tirofiban adjuvant therapy after intravenous thrombolysis with reteplase

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126685
Enrollment
Unknown
Registered
2026-06-13
Start date
2026-06-14
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

cute ischemic stroke

Interventions

Experimental group:Thrombolytic Therapy All enrolled patients received standard intravenous reteplase thrombolysis (two 18-mg intravenous boluses administered 30 minutes apart). Intervention: Tirofiba
Loading dose: 0.4 µg/kg/min intravenously for 30 minutes Maintenance dose: 0.1 µg/kg/min intravenously for up to 47.5 hours Oral antiplatelet therapy: Aspirin (100 mg daily) and/or clopidogrel (75 mg

Sponsors

Pingshan District People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years. 2. Clinically diagnosed with acute ischemic stroke (AIS), with baseline NIHSS score ranging from 4 to 15 points. 3. Symptom onset within = 4 points); (3) Fluctuation of neurological function (NIHSS variability >= 2 points). 7. Written informed consent obtained from the patient or legal authorized representative.

Exclusion criteria

Exclusion criteria: 1. Presence of contraindications to intravenous thrombolysis. 2. Scheduled to receive endovascular therapy. 3. Previous history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation or intracranial aneurysm. 4. Major trauma, surgery or active bleeding within the preceding 3 months. 5. Confirmed hypersensitivity to tirofiban or reteplase. 6. Ongoing treatment with oral anticoagulants or intravenous heparin. 7. Platelet count 1.5, or prolonged APTT. 8. Systolic blood pressure>185 mmHg or diastolic blood pressure > 110 mmHg refractory to antihypertensive management. 9. Blood glucose 22.2 mmol/L. 10. Severe hepatic or renal dysfunction: ALT/AST > 3 times the upper limit of normal (ULN), serum creatinine > 2.0 mg/dL. 11. Pregnant or breastfeeding women. 12. Life expectancy less than 90 days. 13. Any other conditions deemed ineligible for enrollment by the investigators.

Design outcomes

Primary

MeasureTime frame
Incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours, defined according to the NINDS criteria.;

Secondary

MeasureTime frame
Favorable functional outcome at day 90, defined as modified Rankin Scale (mRS) score of 0–1;Functional independence at day 90, defined as modified Rankin Scale (mRS) score of 0–2;Distribution of modified Rankin Scale (mRS) scores (analyzed with ordinal statistical methods);Early neurological improvement (defined as a >= 4-point reduction in NIHSS score at 24 hours after thrombolysis);Recurrence of ischemic stroke within 90 days;0-day quality of life assessment using the EQ-5D-5L questionnaire;Activities of daily living at day 90 (Barthel Index >= 95 points);

Countries

Shenzhen

Contacts

Public ContactKun Xiao

Pingshan District People's Hospital of Shenzhen

14715046376@163.com+86 188 1325 3769

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026