NCT04240834

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,220 (estimated)
• Sponsor: Fu Wai Hospital, Beijing, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Aspirin	Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
DRUG	Ticagrelor	Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2020-01-27
• Last updated: 2024-06-18

Locations

1 site across 1 country: China