PARIS coronary thrombosis risk score combined with D-dimer to guide new oral anticoagulant antithrombotic therapy in patients with acute coronary syndrome after percutaneous coronary intervention: study protocol for the PRIDE-ACS trial.

Abstract

Residual thrombosis risk is an important contributor to ischaemic events in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Although previous studies have shown that rivaroxaban 2.5 mg two times per day in ACS patients with high ischaemic risk can significantly reduce the risk of ischaemic recurrence and mortality, individualised treatment with low-dose rivaroxaban is still rare. Using D-dimer and PARIS (Patterns of non-Adherence to Anti-Platelet Regimen in Stented Patients) coronary thrombosis risk score to identify ACS patients at high ischaemic risk, we aim to investigate whether 3-month low-dose rivaroxaban therapy on the basis of dual antiplatelet therapy (DAPT) could result in reduced ischaemic events without increasing bleeding. This study is a multicentre, prospective, open-label, randomised controlled trial involving 3944 ACS patients undergoing PCI from more than 40 tertiary hospitals in China (ClinicalTrials.gov NCT05638867). Patients with PARIS coronary thrombosis score ≥3 or D-dimer ≥0.28 µg/mL will be 1:1 randomised to the experimental group (rivaroxaban 2.5 mg two times per day for 3 months on the basis of 1 year standard DAPT) or the control group (1 year standard DAPT only). The primary endpoint of this study is major adverse cardiovascular and cerebrovascular events (MACCE), a composite of death, myocardial infarction, unplanned ischaemia-driven revascularisation and systemic embolic events. The safety endpoint is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding events. Institutional Review Board (IRB) approval by the Ethics Committee of Fuwai Hospital was obtained on 22 April 2023 (Approval No. 2023-1980). The investigators will have access to the final dataset. Trial results will be made public through publication in professional journals. NCT05638867.