LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention
- Conditions
- Antiplatelet TherapyCoronary Artery DiseasePercutaneous Coronary Intervention
- Interventions
- Registration Number
- NCT04060914
- Lead Sponsor
- Beijing Anzhen Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ticagrelor(90mg) Ticagrelor 90mg - Clopidogrel(75mg) Clopidogrel 75mg - Ticagrelor(90/60mg) Ticagrelor 90mg/60mg -
- Primary Outcome Measures
Name Time Method Platelet reactivity index (PRI) 90 days (±14) Platelet reactivity of ticagrelor or clopidogrel MD will be measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP) at 90 days after PCI.
- Secondary Outcome Measures
Name Time Method The platelet aggregation ratio 90 days (±14) Platelet aggregation of ticagrelor or clopidogrel MD will be measured using the Light Transmittance Aggregometry method at day 90 after PCI.
Plasma adenosine concentration 90 days (±14) Plasma adenosine concentration in the three treatment groups will be measured using the HPLC-MS at day 90 after PCI.
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE) 1 year MACCE includes all-cause death, non-fatal stroke, non-fatal myocardial infarction (MI), and ischemic-driven revascularization.
Trial Locations
- Locations (1)
Beijing Anzhen Hospital
🇨🇳Beijing, Beijing, China