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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Antiplatelet Therapy

Treatments: Drug: Ticagrelor 90mg; Drug: Clopidogrel 75mg; Drug: Ticagrelor 90mg/60mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04060914

ANZHEN HOSPITOL-LY-01

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

Ticagrelor(90mg)

Experimental group

Treatment:

Drug: Ticagrelor 90mg

Ticagrelor(90/60mg)

Experimental group

Treatment:

Drug: Ticagrelor 90mg/60mg

Clopidogrel(75mg)

Active Comparator group

Treatment:

Drug: Clopidogrel 75mg