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

Coronary Artery Disease Clinical Trial

— LOTIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04060914
• Other study ID #: ANZHEN HOSPITOL-LY-01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 30, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2019
• Source: Beijing Anzhen Hospital
• Contact: Yi Zhang, PhD
• Phone: 86-010-64456609
• Email: phd-zhangyi[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Antiplatelet Therapy
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Drug:
• Ticagrelor 90mg
Ticagrelor 90 mg plus aspirin for 12 months
• 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
• Clopidogrel 75mg
Clopidogrel 75mg plus aspirin for 12 months

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)