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Open Access 01-12-2022 | Ticagrelor | Study protocol

A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY

Authors: Yanan Pang, Minglu Ma, Jiachun Xia, Dong Wang, YanChen, Jianfei Ye, Zhongwei Jia, Sicheng Wu, Jian Yang, Lei Hou

Published in: Trials | Issue 1/2022

Abstract

Background

Current guidelines recommend that patients with acute coronary syndrome (ACS) who have successfully undergone percutaneous coronary intervention (PCI) should continue to use dual antiplatelet therapy (DAPT) for 12 months. The long-term use of standard-dose dual antiplatelet therapy will increase the risk of bleeding. An optimized antiplatelet strategy that can prevent ischemic events and reduce the risk of bleeding remains to be explored.

Methods

The study is a prospective, multicenter, randomized, open-label, controlled study involving 2090 patients from six clinical centers in China. Through the interactive web response system (IWRS), ACS patients undergoing successful PCI will be randomly divided into the low-dose ticagrelor group or the normal-dose ticagrelor group, after taking 100 mg aspirin and 90 mg ticagrelor bid for 1 week. The primary endpoint is a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, repeat revascularization, and stroke. The secondary endpoints are bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria, cardiovascular death, acute myocardium infarction, and coronary revascularization at 1 year.

Discussion

Recent studies have confirmed that 90 mg ticagrelor alone can safely and effectively reduce bleeding without increasing ischemic events of patients with ACS after PCI. Compared with standard-dose DAPT, whether low-dose ticagrelor combined with aspirin can ensure the anti-ischemic effect while reducing the bleeding risk remains unclear in Chinese patients.

The TIGER study will be the first large-scale, multicenter study to compare the efficacy and safety of low-dose and standard-dose ticagrelor combined with aspirin in ACS patients 1 week after successful PCI.

Trial registration

Clinicaltrials.gov NCT04255602. Registered on 5 February 2020.

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Title: A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY
Authors: Yanan Pang
Minglu Ma
Jiachun Xia
Dong Wang
YanChen
Jianfei Ye
Zhongwei Jia
Sicheng Wu
Jian Yang
Lei Hou
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Ticagrelor
Acute Coronary Syndrome
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06124-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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