Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Ischemic Stroke

Launched by BEIJING TIANTAN HOSPITAL · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination of two medications, ticagrelor and aspirin, given alongside a treatment called intravenous thrombolysis for patients who have had an acute ischemic stroke. The goal is to see if this combination therapy can improve recovery and lead to better overall function 90 days after the stroke, compared to patients who do not receive this specific treatment.

To be eligible for the trial, participants need to be between 18 and 80 years old and must have experienced a stroke within the last six hours. They should also be planning to receive thrombolysis, which is a treatment that helps dissolve blood clots. However, some individuals may not qualify, such as those with certain medical conditions or those who are pregnant. If someone joins the trial, they can expect to receive either the ticagrelor and aspirin treatment or a placebo (a treatment with no active ingredients) and will be monitored to see how well they recover in the following weeks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18-80 years old;
• • 2. Clinical diagnosis of acute ischemic stroke;
• • 3. Time from onset to treatment ≤6.0 hours;
• • 4. Having received or planning to receive intravenous thrombolytic therapy;
• • 5. NIHSS score of 4-10 points, and at least one of the 5th (upper limb exercise) or 6 th (lower limb exercise) scale is ≥1 point;
• • 6. Signed informed consent.
• Exclusion Criteria:
• • 1. Planning to receive endovascular therapy;
• • 2. mRS scores ≥2 points before the onset;
• • 3. Receiving any antiplatelet therapy after the onset;
• • 4. Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), identified by CT/MRI;
• • 5. Pre-existing clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
• • 6. Pre-existing atrial fibrillation or anticoagulant therapy (warfarin, heparin, thrombin inhibitors or factor Xa inhibitors);
• • 7. Hepatic or renal insufficiency (hepatic insufficiency refers to the alanine transaminase (ALT) value \> 2 times the upper limit of normal value or aspartate aminotransferase (AST) times \> 2 times the upper limit of normal value; renal insufficiency refers to creatinine values \> 2 times the upper limit of normal value);
• • 8. Allergic to Ticagrelor or Aspirin or thier components and excipients;
• • 9. Women who are pregnant or breastfeeding, or those with negative pregnancy test records while refusing to use effective contraceptives;
• • 10. Having participated investigational drugs or device tests within 30 days;
• • 11. Being considered inappropriate to participate by researchers.