Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

Abstract

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.

• Authors: Yan Yan, Xiao Wang, Jincheng Guo, Yongjun Li, Hui Ai, Wei Gong, Bin Que, Lei Zhen, Jiapeng Lu, Changsheng Ma, Gilles Montalescot, Shaoping Nie
• Journal: American heart journal (Am Heart J) Vol. 227 Pg. 19-30 (09 2020) ISSN: 1097-6744 [Electronic] United States
• PMID: 32663660 (Publication Type: Clinical Trial Protocol, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 Elsevier Inc. All rights reserved.

Chemical References

• Anticoagulants
• Enoxaparin
• Hirudins
• Peptide Fragments
• Recombinant Proteins
• Heparin
• bivalirudin

Topics

• Anticoagulants (administration & dosage)
• Double-Blind Method
• Enoxaparin (administration & dosage)
• Heparin (administration & dosage)
• Hirudins (administration & dosage)
• Humans
• Multicenter Studies as Topic (methods)
• Peptide Fragments (administration & dosage)
• Percutaneous Coronary Intervention
• Postoperative Period
• Prospective Studies
• Randomized Controlled Trials as Topic (methods)
• Recombinant Proteins (administration & dosage)
• ST Elevation Myocardial Infarction (drug therapy, surgery)
• Time Factors