Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention

NCT ID: NCT04240834

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2026-12-31

Brief Summary

The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.

Detailed Description

This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.

Conditions

Acute Coronary Syndrome; Interventional Cardiology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LD group

Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Ticagrelor

Intervention Type: DRUG

Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Control group

Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Ticagrelor

Intervention Type: DRUG

Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Interventions

Aspirin

Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Intervention Type: DRUG

Ticagrelor

Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Intervention Type: DRUG

Other Intervention Names

Acetylsalicylic Acid; Brilinta/Brilique

Eligibility Criteria

Inclusion Criteria

• ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent
• Able and willing to provide informed consent and participate in 12 months follow-up period
• Able to receive DAPT treatment

1. Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative <55 years old or in first-degree female relative <65 years old)

2. Repeated myocardial infarction

3. Positive serum cardiac troponin I/T

4. Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)

5. Type 2 diabetes mellitus under medication

6. Chronic kidney disease (eGFR<60 mL/min/1.73 m2 or CrCl<60ml/min)

1. LM lesion requiring stents

2. Proximal LAD lesion(s) requiring stents

3. Bypass grafts lesion(s) requiring stents

4. Overall stent length ≥60 mm

5. History of in-stent thrombosis

6. Bifurcation lesions requiring at least 2 stents

7. Over two vessels lesions requiring stents

8. Calcified target lesion(s) requiring atherectomy

9. The intraoperative occurrence of no-reflow or slow-flow

10. Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3)

Exclusion Criteria

• Need for chronic oral anticoagulation
• With cardiomyopathy（HCM/DCM/RCM）
• With severe ventricular arrhythmia requiring ICD implantation
• With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease)
• With severe infectious disease（active hepatitis B, active hepatitis C, AIDS）
• With hematological disorders（thrombocytopenia, severe anemia, leukaemia）
• With severe liver disease or kidney failure
• With malignant tumor
• With cognitive impairment
• Unable or unwilling to provide informed consent or undergo follow-up

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

Sponsors

Fu Wai Hospital, Beijing, China

OTHER

Sponsor Role: lead

Responsible Party

Qian Haiyan

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haiyan Qian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, Beijing, China

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyan Qian, MD, PhD

Role: CONTACT

ahqhy712@163.com

+8613811386143

Zhiyao Wei

Role: CONTACT

weizhiyaoyx@163.com

+8615521192379

Facility Contacts

Haiyan Qian, MD, PhD

Role: primary

ahqhy712@163.com

+8613811386143

Other Identifiers

2019XK320061

Identifier Type: -

Identifier Source: org_study_id