Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)

Acute Ischemic Stroke Clinical Trial

— ASSET-IT  

Official title:

Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06134622
• Other study ID #: ASSET-IT
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: November 2023
• Source: The First Affiliated Hospital of University of Science and Technology of China
• Contact: Wei Hu, MD, PhD
• Phone: +86 055162284313
• Email: andinghu[@]ustc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.

Description:

The standard treatment for acute ischemic stroke is intravenous thrombolysis to dissolve fibrin and restore blood flow. However, reocclusion of blood vessels and stroke progression remain challenges after this treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 832
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Onset of ischemic stroke symptoms =4;5 hours, treated with intravenous alteplase or tenecteplase according to guidelines;

2. NIHSS score before intravenous thrombolysis =25;

3. Age =18 and =80 years;

4. Patient or legal representative signs an informed consent form.

Exclusion Criteria:

1. Presence of contraindications for intravenous thrombolysis;

2. Pre-stroke mRS score >1;

3. Patients undergoing mechanical thrombectomy or other intravascular treatments (e;g;, intra-arterial thrombolysis);

4. Known history of atrial fibrillation or emergency electrocardiogram indicating atrial fibrillation;

5. Pregnant or lactating women;

6. NCCT, CTA source images, or MRI-DWI showing ASPECTS or PC-ASPECTS <6;

7. Currently participating in other clinical trials;

8. Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours;

9. Severe renal failure, defined as serum creatinine >3.0 mg/dl (or 265.2 µmol/l) or glomerular filtration rate [GFR] <30, or patients requiring hemodialysis or peritoneal dialysis;

10. Liver dysfunction (ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal);

11. Known allergy to tirofiban or other IIb/IIIa inhibitors;

12. Expected lifespan <1 year;

13. Patients unable to complete the 90-day follow-up (e.g., no fixed residence, overseas patients).

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Intravenous thrombolysis plus tirofiban
Patients randomized to the Tirofiban group will receive continuous intravenous infusion of tirofiban for 24 hours: initial infusion of 0.4 µg/kg/min for 30 minutes followed by a continuous infusion of 0.1 µg/kg/min for up to 23.5 hours. The tirofiban placebo will be infused in a similar fashion.
• Intravenous thrombolysis plus placebo
placebo (saline)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of University of Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a modified Rankin Score of 0-1	modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)	90 (± 14 days) after procedure
Secondary	a modified Rankin Score of 0-3	modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)	90 (± 14 days) after procedure
Secondary	Modified Rankin Score	modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)	90 (± 14 days) after procedure
Secondary	NIHSS score	The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.	24 hours after procedure
Secondary	mortality	(Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%	90 (± 14 days) after procedure
Secondary	symptomatic intracerebral hemorrhage (ICH)	SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by =4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.	within 72 hours after procedure