A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of tirofiban in combination with intravenous thrombolytic therapy with alteplase in acute ischemic stroke

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GrandPharma (China) Co., Ltd.
• Treatments: Tirofiban

Criteria

Inclusion Criteria:

1. According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, the patient is clinically diagnosed as acute ischemic stroke;

2. ≥ 18 years of age, regardless of gender;

3. Patients who have received or are scheduled to receive intravenous thrombolysis with alteplase, that is, receiving thrombolysis with alteplase within 4.5 hours of onset of ischemic stroke;

4. Intravenous antiplatelet therapy is acceptable within 12 hours of receiving intravenous thrombolysis;

5. NIHSS score: 4 ≤ screening period/baseline NIHSS score ≤ 25;

6. Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1 point);

7. The subject or his/her guardian participates voluntarily and signs the ICF.

Exclusion Criteria:

1. Combined with atrial fibrillation or clear evidence of cardiogenic embolism (e.g., known left atrial/left ventricular mural thrombosis, etc.);

2. CT suggests large-area anterior circulation infarction (ASPECT score is < 6 points or infarction volume is ≥ 70 mL or infarction area is > 1/3 of the middle cerebral artery blood supply area);

3. Significant head trauma or stroke within 3 months prior to screening;

4. Previous history of intracranial hemorrhage (e.g., subarachnoid hemorrhage, and intracerebral hemorrhage);

5. Previous intracranial tumor, arteriovenous malformation or aneurysm;

6. Intracranial or spinal surgery and biopsy within 3 months prior to screening;

7. Prolonged or traumatic cardiopulmonary resuscitation (> 2 min), delivery within the past 10 days or recent puncture of a non-compression vessel (e.g., subclavian vein or jugular vein);

8. Presence of active internal hemorrhage (e.g., gastrointestinal, urinary tract or retinal hemorrhage, etc.);

9. Hemorrhagic tendency (including but not limited to): platelet count < 100 × 109/L during screening; heparin treatment within the last 48 hours and APTT exceeding the upper limit of laboratory normal value; oral administration of warfarin at the time of screening, INR > 1.7; oral administration of new anticoagulants; and using direct thrombin or factor Xa inhibitors;

10. Hypertension is not controlled after active antihypertensive therapy: systolic blood pressure is ≥ 180 mmHg or diastolic blood pressure is ≥ 100 mmHg;

11. Blood glucose concentration is < 50 mg/dL (2.8 mmol/L) or > 400 mg/dL (22.2 mmol/L);

12. Severe liver damage, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;

13. Serious renal insufficiency (creatinine clearance rate is < 30 mL/min);

14. Currently undergoing renal dialysis;

15. Aortic dissection;

16. Major surgery or serious trauma within 30 days prior to screening;

17. Gastrointestinal or urethral hemorrhage within 30 days prior to screening;

18. History of acute myocardial infarction within 3 months prior to screening;

19. It is known at the time of screening that subjects plan to undergo coronary, carotid or peripheral arterial revascularization during the trial;

20. Female subjects who are serum pregnancy test positive, pregnant/lactating women, or women of childbearing potential who plan to have a pregnancy during the 12-month period, or women of childbearing potential or male subjects who are unwilling to take appropriate contraceptive measures during the trial;

21. Users who are known to be allergic or contraindicated to the investigational product;

22. Life expectancy of < 6 months due to any advanced disease;

23. Patients who have participated in drug or device trials within one month;

24. Patients with poor peripheral venous filling who cannot establish two standard peripheral venous lines;

25. Stroke accompanied by seizures;

26. Other conditions that the investigator considers inappropriate for participation in the clinical study, such as inability to understand and/or follow the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders.