Key result
This study protocol describes the TIGER trial, a planned randomized non-inferiority study comparing low-dose versus standard-dose ticagrelor plus aspirin in 2,090 patients with acute coronary syndrome after PCI.
Why the study?
Standard-dose DAPT increases bleeding risk, and whether low-dose ticagrelor combined with aspirin can preserve anti-ischemic efficacy while reducing bleeding remains unclear in Chinese patients with ACS after PCI.
Does low-dose ticagrelor combined with aspirin prevent ischemic events and reduce bleeding risk compared to standard-dose ticagrelor in ACS patients after successful PCI?
RCT (n=2,090)
Open-label
1:1 via interactive web response system (IWRS), stratified by ACS, age, sex, and diabetes
Yes
Does low-dose ticagrelor combined with aspirin prevent ischemic events and reduce bleeding risk compared to standard-dose ticagrelor in ACS patients after successful PCI?
The TIGER study protocol outlines a large-scale randomized trial to determine if low-dose ticagrelor with aspirin is non-inferior to standard-dose for ischemic events while reducing bleeding in Chinese ACS patients post-PCI.
TIGER results needed before considering low-dose ticagrelor de-escalation in ACS; leaves open optimal P2Y12 dosing post-PCI.
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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Pang et al. (2022) conducted an RCT in Acute coronary syndrome (ACS) after successful PCI (n=2,090). Low-dose ticagrelor plus aspirin vs. Standard-dose ticagrelor (90 mg bid) plus aspirin (100 mg qd) was evaluated on Composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, revascularization, and stroke within 1 year after PCI. This study protocol describes the TIGER trial, a planned randomized non-inferiority study comparing low-dose versus standard-dose ticagrelor plus aspirin in 2,090 patients with acute coronary syndrome after PCI.
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