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

NCT ID: NCT04060914

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2021-12-30

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.

Conditions

Antiplatelet Therapy; Coronary Artery Disease; Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ticagrelor(90mg)

Group Type: EXPERIMENTAL

Ticagrelor 90mg

Intervention Type: DRUG

Ticagrelor 90 mg plus aspirin for 12 months

Ticagrelor(90/60mg)

Group Type: EXPERIMENTAL

Ticagrelor 90mg/60mg

Intervention Type: DRUG

1 month after treatment with ticagrelor 90 mg plus aspirin, followed by treatment with ticagrelor 60 mg plus aspirin for 11 months

Clopidogrel(75mg)

Group Type: ACTIVE_COMPARATOR

Clopidogrel 75mg

Intervention Type: DRUG

Clopidogrel 75mg plus aspirin for 12 months

Interventions

Ticagrelor 90mg

Ticagrelor 90 mg plus aspirin for 12 months

Intervention Type: 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

Intervention Type: DRUG

Clopidogrel 75mg

Clopidogrel 75mg plus aspirin for 12 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lin Yang

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yi Zhang, PhD

Role: CONTACT

phd-zhangyi@outlook.com

86-010-64456609

Yang Lin, PhD

Role: CONTACT

linyang3623@outlook.com

86-010-64456609

Facility Contacts

Yang Lin, PhD

Role: primary

linyang3623@outlook.com

86-010-64456609

Xiujing Shi, MD

Role: backup

xiujingshi@163.com

86-010-64456609

Other Identifiers

ANZHEN HOSPITOL-LY-01

Identifier Type: -

Identifier Source: org_study_id