Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Isch… (NCT06316570) | Clinical Trial Compass
CompletedPhase 3
Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Ischemic Stroke
China1,382 participantsStarted 2024-04-03
Plain-language summary
Early antiplatelet therapy is promising for further improvement of functional prognosis on the basis of intravenous thrombolytic therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of the early dual antiplatelet therapy (within 6 hours of onset ) of ticagrelor with aspirin combined with intravenous thrombolysis in improving good functional outcome (mRS score 0-1) at 90 days inpatients with ischemic stroke.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 re…