- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06316570
Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Ischemic Stroke (TAPIS)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Theoretically, early administration of antiplatelet therapy is expected to counteract platelet aggregation during intravenous thrombolysis, improving the efficacy of intravenous thrombolysis as well as the functional prognosis. According to current evidence, mainstream guidelines clearly state that the administration of intravenous aspirin (or other antiplatelet agents) within 24 hours of Recombinant tissue plasminogen activator (rt-PA) thrombolytic therapy is not recommended as an adjunctive treatment of intravenous thrombolysis therapy, despite the fact that rt-PA thrombolytic therapy is still acceptable for patients who have received antiplatelet therapy before the onset of stroke. Evidence from high-quality clinical trials for the routine use of oral antiplatelet drugs before and within 24 hours of intravenous thrombolysis in acute ischemic stroke (AIS) patients is quite limited. Meanwhile, trials including INSPIRES and CHANCE 2 have demonstrated that early initiation of dual antiplatelet therapy could significantly reduce the risk of recurrence and thus improve the functional prognosis without significantly increasing the risk of bleeding, providing a promising treatment for early oral antiplatelet therapy in patients undergoing intravenous thrombolysis.
This trial is a multicenter, randomized, double-blind, placebo-parallel controlled designed clinical trial. A total of 1380 patients (aged 18-80 years) who have a new diagnosed ischemic stroke (within 6 hours of onset), a NIHSS score of 4-10 points, and have received/are planned to receive intravenous thrombolysis therapy with will be enrolled from 50 centers in China. Patients will be randomly assigned into intervention (dual antiplatelet therapy of Ticagrelor and Aspirin) and control group (placebo) by the ratio of 1:1. Face to face or distance (via video or telephone) interviews will be made at baseline, 7 ± 1 days, 30 ± 3 days, 60 ± 5 days and 90 ± 7 days after randomization.
Primary outcome is defined as good functional outcomes (mRS score of 0-1 points) at 90 days. Secondary outcomes include neurologic improvement,quality of life ( quality-of-life EuroQol-5 Dimensions scale),activity of daily living (Barthel index),recurrent ischemic stroke. Safety outcomes, relating to antiplatelet and intravenous thrombolysis therapy (i.e., symptomatic intracranial hemorrhage, parenchymal hematoma type 2, bleeding events) will also be investigated.
The Chi-square test was used to compare the proportion difference of good functional outcomes between two groups after 90 days of treatment, and the 95% confidence interval (CI) was calculated by using the Newcombe method. The generalized linear regression model was used to calculate the relative risk (RR) and its 95%CI. For survival outcomes, hazard ratio (HR) and 95% CI were calculated using the Cox proportional risk model.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Anxin Wang, MD, PhD
- Phone Number: +86 1059975806
- Email: anxin0907@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dual Antiplatelet Therapy
This group will receive early dual antiplatelet therapy (Ticagrelor with Aspirin) combined with intravenous thrombolysis within 6 hours of the onset.
|
Day 1(within 6.0 hours of onset, before or after intravenous thrombolysis) : Ticagrelor (180mg) + Aspirin (100mg), one dose; Days 2-7: Ticagrelor (90mg/time, twice/day) + open-label Aspirin (100mg/time, once/day) ; Days 8-90: open-label Aspirin (100mg/time, once/day).
Other Names:
|
Placebo Comparator: Placebo
This group will receive placebo treatment (with same form and dosage) combined with intravenous thrombolysis within 6 hours of the onset.
|
Day 1(within 6.0 hours of onset, before or after intravenous thrombolysis) : Placebo of Ticagrelor (180mg) + Placebo of Aspirin (100mg), one dose; Days 2-7: Placebo of Ticagrelor (90mg/time, twice/day) + open-label Aspirin (100mg/time, once/day) ; Days 8-90: open-label Aspirin (100mg/time, once/day).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excellent functional outcome
Time Frame: 90 days
|
Modified Rankin Scale (mRS) score of 0-1 points; The mRS score ranges from 0 to 6, with higher scores indicating worse functional outcome.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 90 days
|
90 days
|
|
Recurrent ischemic stroke
Time Frame: 90 days
|
90 days
|
|
mRS score of 0-2 points
Time Frame: 90 days
|
The mRS score ranges from 0 to 6, with higher scores indicating worse functional outcome.
|
90 days
|
Distribution of mRS score
Time Frame: 90 days
|
The distribution of mRS score of 0 to 6 points; The mRS score ranges from 0 to 6, with higher scores indicating worse functional outcome.
|
90 days
|
Neurologic improvement
Time Frame: 7 days
|
NIHSS score decreasing by 4 points or more than the value at baseline; The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.
|
7 days
|
Activity of daily living (Barthel index ≥95 points)
Time Frame: 90 days
|
The Barthel index score ranges from 0 to 100, with higher scores indicating greater independence.
|
90 days
|
Symptomatic intracranial hemorrhage (ECASS-III)
Time Frame: 36 hours
|
36 hours
|
|
Symptomatic intracranial hemorrhage (ECASS-III)
Time Frame: 7 days
|
7 days
|
|
Parenchymal hematoma type 2 (SIST-MOST)
Time Frame: 36 hours
|
36 hours
|
|
Parenchymal hematoma type 2 (SIST-MOST)
Time Frame: 7 days
|
7 days
|
|
Bleeding events (GUSTO)
Time Frame: 90 days
|
90 days
|
|
Severe adverse events
Time Frame: 90 days
|
90 days
|
|
Quality of life (EQ-5D scale)
Time Frame: 90 days
|
The European Quality of Life 5-Dimension(EQ-5D)questionnaire for measuring generic health status.
The 5-level EQ-5D version (EQ-5D-5L) comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The sum score on each of the five dimensions ranges from 5 (all domains have level 1) to 25 (all domains have level 5), with higher scores indicating worse health-related quality of life.
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yilong Wang, MD, PhD, Beijing Tiantan Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Cerebral Infarction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
Other Study ID Numbers
- HX-A-2023044
- SF 2024-2-2045 (Other Grant/Funding Number: Capital health development research project)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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