Acute Ischemic Stroke
Conditions
Keywords
tirofiban, intravenous thrombolysis
Brief summary
To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.
Detailed 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.
Interventions
DRUGIntravenous 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.
DRUGIntravenous thrombolysis plus placebo
placebo (saline)
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
randomized, double-blind trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Onset of ischemic stroke symptoms within ≤ 4.5 hours\*, treated with intravenous rt-PA or TNK according to guidelines; 2. NIHSS score of 4-25 before intravenous thrombolysis; 3. Age ≥ 18 years; 4. Able to receive the designated study drug within 60 minutes after intravenous thrombolysis; 5. Informed consent signed by the patient or their legal representative. \*Symptom onset is defined as the last known well time.
Exclusion criteria
1. Presence of contraindications to intravenous thrombolysis; 2. Pre-stroke mRS score \> 1; 3. Patients planned to undergo mechanical thrombectomy or other endovascular treatments (e.g., intra-arterial thrombolysis); 4. Patients with a history of atrial fibrillation or emergency ECG indicating atrial fibrillation; 5. Pregnant or lactating women; 6. NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS \< 6; 7. If NIHSS worsens by 2 or more points between start of thrombolysis and start of study drug, repeat brain imaging rules out new intracranial hemorrhage; 8. Severe leukoaraiosis; 9. Currently participating in other clinical trials; 10. Known genetic or acquired bleeding diathesis, or received warfarin and INR \> 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours; 11. 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; 12. Liver dysfunction (ALT \> 2 times the upper limit of normal or AST \> 2 times the upper limit of normal); 13. Known allergy to tirofiban or other IIb/IIIa inhibitors; 14. Life expectancy \< 1 year; 15. Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patients, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a modified Rankin Score of 0-1 | 90 (± 14 days) after procedure | 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) |
| mortality | 90 (± 14 days) after procedure | (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100% |
| symptomatic intracerebral hemorrhage (ICH) | within 36 hours after procedure | 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 36 hours or any hemorrhage leading to death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| a modified Rankin Score of 0-3 | 90 (± 14 days) after procedure | 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) |
| Modified Rankin Score | 90 (± 14 days) after procedure | 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) |
| NIHSS score | 24 hours after procedure | 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. |
Countries
China
Outcome results
None listed