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

Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Interventional Cardiology
• Intervention / Treatment: Drug: Aspirin; Drug: Ticagrelor

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.

• Study Type: Interventional
• Enrollment (Estimated): 1220
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Haiyan Qian, MD, PhD; Phone Number: +8613811386143; Email: ahqhy712@163.com
• Study Contact Backup: Name: Zhiyao Wei; Phone Number: +8615521192379; Email: weizhiyaoyx@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital
      • Contact: Haiyan Qian, MD, PhD; Phone Number: +8613811386143; Email: ahqhy712@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Enrollment into the study will require meeting at least one angiographic or clinical inclusion and none of the exclusion criteria.

Clinical inclusion criteria:

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)

Angiographic Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LD group; Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months	Drug: Aspirin; Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT); Other Names: Acetylsalicylic Acid; Drug: Ticagrelor; Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT); Other Names: Brilinta/Brilique
Active Comparator: Control group; Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months	Drug: Aspirin; Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT); Other Names: Acetylsalicylic Acid; Drug: Ticagrelor; Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT); Other Names: Brilinta/Brilique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac and cerebral events (MACCEs)	Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization	12 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding episode (Key secondary endpoint)	Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2)	12 months after randomization
Platelet function	Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)	12 months after randomization
Medication adherence		12 months after randomization
Bleeding-related withdrawal		12 months after randomization

Collaborators and Investigators

• Sponsor: Fu Wai Hospital, Beijing, China
• Investigators: Principal Investigator: Haiyan Qian, MD, PhD, Fuwai Hospital, Beijing, China

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Ticagrelor; Aspirin; PCI; ACS; DAPI
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Ischemia; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Ticagrelor
• Other Study ID Numbers: 2019XK320061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No