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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Antiplatelet Therapy
• Intervention / Treatment: Drug: Ticagrelor 90mg; Drug: Ticagrelor 90mg/60mg; Drug: Clopidogrel 75mg

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ticagrelor(90mg)	Drug: Ticagrelor 90mg; Ticagrelor 90 mg plus aspirin for 12 months
EXPERIMENTAL: Ticagrelor(90/60mg)	Drug: Ticagrelor 90mg/60mg; 1 month after treatment with ticagrelor 90 mg plus aspirin, followed by treatment with ticagrelor 60 mg plus aspirin for 11 months
ACTIVE_COMPARATOR: Clopidogrel(75mg)	Drug: Clopidogrel 75mg; Clopidogrel 75mg plus aspirin for 12 months

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 30, 2019
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (ACTUAL): August 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Adenosine; ticagrelor; clopidogrel
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: ANZHEN HOSPITOL-LY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No