Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045156
• Other study ID #: ADVENT
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: May 2024
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT

Description:

Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size. Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1084
• Est. completion date: December 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age=18 years old;

2. Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;

3. Total National Institute of Health stroke scale (NIHSS)=4 or single limb motor item score=2, and total NIHSS=15 after IVT;

4. Tirofiban or placebo treatment can be initiated within 6h after IVT;

5. mRS score before onset= 1;

6. Intracranial hemorrhage is ruled out by CT head after IVT;

7. Systolic blood pressure before enrollment= 160mmHg;

Exclusion Criteria:

1. Received or plan to undergo bridge therapy;

2. Large area of infarct indicated by radiological imaging(=1/3 of middle cerebral artery supply area);

3. Atrial fibrillation or suspected cardiac embolism;

4. Accompanied by epileptic seizures;

5. Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;

6. Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;

7. Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;

8. Severe renal or liver insufficiency; ALT or AST>3 times of the upper limit of normal value or above; creatinine clearance rate<30 mL/min, creatinine>200µmol/L;

9. Life expectancy less than 3 months;

10. Pregnant or lactating women;

11. Known allergy to tirofiban;

12. Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;

13. Patients who are unwilling to be followed up or likely to have poor treatment compliance;

14. Other situations that the researcher deems unsuitable for inclusion in the study.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Tirofiban
Tirofiban is a selective glycoprotein?b/?a receptor inhibitor, which inhibits platelet aggregation and thrombi formation
• Tirofiban simulant
Tirofiban simulant is placebo packed the same style as tirofiban

Locations

Country	Name	City	State
China	The first hospital of Jilin University	Chang chun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage is defined according to the ECASS Classification	within 24 hours of completion of study drug infusion, hospitalization
Other	Hemorrhagic transformation	defined according to the ECASS Classification	24 hours after IVT, hospitalization
Primary	Proportion of patients of modified Rankin Scale (mRS)=1	mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome	90±7 days
Secondary	Proportion of patients of mRS=2	mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome	90±7 days
Secondary	Distribution of mRS	mRS depicts functional outcome of stroke, which ranges from 0-6	90±7 days
Secondary	National Institute of Health stroke scale (NIHSS)	National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome	24 hours after IVT, 7 days