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Combining Ticagrelor and Aspirin with Thrombolysis for Ischemic Stroke

Efficacy and Safety of Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis in Patients With Ischemic Stroke (TAPIS): a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial

PHASE3 · Beijing Tiantan Hospital · NCT06316570

This study is testing if giving ticagrelor and aspirin along with a clot-busting treatment can help people who have had an ischemic stroke recover better and have fewer bleeding issues.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1380 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorBeijing Tiantan Hospital (other)
Locations66 sites (Beijing, Beijing and 65 other locations)
Trial IDNCT06316570 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind trial evaluates the efficacy and safety of early dual antiplatelet therapy using ticagrelor and aspirin in conjunction with intravenous thrombolysis for patients diagnosed with acute ischemic stroke. The treatment is administered within 6 hours of symptom onset to improve functional outcomes at 90 days, as measured by the modified Rankin Scale (mRS). The study aims to determine if this combination can enhance the effectiveness of thrombolysis while minimizing the risk of bleeding. A total of 1380 patients aged 18-80 will be enrolled to assess the potential benefits of this approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have experienced a new ischemic stroke within 6 hours and are eligible for intravenous thrombolytic therapy.

Not a fit: Patients with pre-existing bleeding disorders, significant prior disability, or those receiving anticoagulant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: Previous studies, such as INSPIRES and CHANCE 2, have shown promising results for early dual antiplatelet therapy in similar patient populations.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Beijing, Beijing and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ischemic Stroke, Acute, Ischemic Stroke, Antiplatelet Therapy, Intravenous Thrombolysis, Randomized Controlled Trial, Double Blind Study, Multicenter Study, Clinical Trial

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.