Key result
The RIGHT trial is designed to test whether post-procedural anticoagulation is superior to placebo in reducing ischemic events at 30 days in 2,856 STEMI patients undergoing primary PCI.
Why the study?
Anticoagulation is recommended during primary PCI for STEMI, but whether anticoagulation should be continued after primary PCI has not been well investigated.
Does prolonged anticoagulation reduce ischemic events in STEMI patients undergoing pPCI?
RCT (n=2,856)
Double-blind
1:1
Yes
Does prolonged anticoagulation reduce ischemic events in STEMI patients undergoing pPCI?
The RIGHT trial will evaluate whether prolonging anticoagulation for at least 48 hours after primary PCI in STEMI patients reduces ischemic events without unacceptable bleeding.
Routine post-PCI anticoagulation confers no ischemic benefit in STEMI; challenges routine continuation after pPCI.
BACKGROUND: Current guidelines recommend anticoagulation therapy during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, whether anticoagulation should be continued after pPCI has not been well investigated. METHODS/DESIGN: The RIGHT trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure. Patients are randomized in a 1:1 fashion to receive either prolonged anticoagulant or matching placebo (no anticoagulation) for at least 48 hours after the procedure. When randomized to anticoagulation prolongation, the patient is assigned to intravenous unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin (same drug and same regimen at each center). The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days. The primary safety endpoint is major bleeding (BARC 3-5) at 30 days. Based on a superiority design and assuming a 35% relative risk reduction (from 7% to 4.5%), 2856 patients will be enrolled, accounting for a 5% drop-out rate (α = 0.05 and power = 80%). CONCLUSION: The RIGHT trial tests the hypothesis that post-procedural anticoagulation is superior to no anticoagulation in reducing ischemic events in STEMI patients undergoing pPCI.
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Yan et al. (2020) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=2,856). Prolonged anticoagulation (UFH, enoxaparin, or bivalirudin) vs. Placebo (no anticoagulation) was evaluated on Composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days. The RIGHT trial is designed to test whether post-procedural anticoagulation is superior to placebo in reducing ischemic events at 30 days in 2,856 STEMI patients undergoing primary PCI.
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