LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogrel for patients with ACS after PCI.

Official Title
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LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Conditions
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Antiplatelet Therapy, Coronary Artery Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Ticagrelor 90mg
* Drug: Ticagrelor 90mg/60mg
* Drug: Clopidogrel 75mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree to sign the Informed Consent; Male or female, ≥ 18 years of age, and ≤ 70 years of age Patient presents with acute coronary syndrome (ACS) Planned to undergo PCI Planned to DAPT for 1 year after PCI Exclusion Criteria: Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit. Patients cannot use ticagrelor or clopidogrel due to contraindications or other reasons. Patients with active pathological hemorrhage or a history of intracranial hemorrhage Patient unable to receive 12 months of dual anti-platelet therapy Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI Patient or physician refusal to enroll in the study History of intracranial hemorrhage Patient has a history of bleeding diathesis or coagulopathy Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor) Patient with cardiogenic shock or mechanical circulatory assist devices placed Patient with active liver diseases Patient with severe renal insufficiency (eGFR <30ml/min/1.73m2 based on simplified MDRD equation or CrCl <30ml/min based on Cockcroft-Gault equation) Patient has a malignancy or a life expectancy of less than one year Platelet count <100 000/μL, or hematocrit <32% or >52%, or white blood cell count <3000/μL Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor(90mg)<br> | Drug: Ticagrelor 90mg<br>* Ticagrelor 90 mg plus aspirin for 12 months<br>|
| Experimental: Ticagrelor(90/60mg)<br> | Drug: Ticagrelor 90mg/60mg<br>* 1 month after treatment with ticagrelor 90 mg plus aspirin, followed by treatment with ticagrelor 60 mg plus aspirin for 11 months<br>|
| Active Comparator: Clopidogrel(75mg)<br> | Drug: Clopidogrel 75mg<br>* Clopidogrel 75mg plus aspirin for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity index (PRI) | Platelet reactivity of ticagrelor or clopidogrel MD will be measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP) at 90 days after PCI. | 90 days (±14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE) | MACCE includes all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization. | 1 year | 
| The platelet aggregation ratio | Platelet aggregation of ticagrelor or clopidogrel MD will be measured using the Light Transmittance Aggregometry method at day 90 after PCI. | 90 days (±14) | 
| Plasma adenosine concentration | Plasma adenosine concentration in the three treatment groups will be measured using the HPLC-MS at day 90 after PCI. | 90 days (±14) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ticagrelor, clopidogrel, Percutaneous Coronary Intervention, Coronary Artery Disease, Adenosine