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: Rationale and design of the PRIDE-ACS trial

Background Residual thrombosis risk is an important contributor to ischemic events in patients with Acute Coronary Syndrome (ACS) after Percutaneous Coronary Intervention (PCI). Although previous studies have shown that rivaroxaban 2.5mg twice daily in ACS patients with high ischemic risk can significantly reduce the risk of ischemic recurrence and mortality, individualized treatment with low-dose rivaroxaban is still rare. Aim Using D-dimer and PARIS coronary thrombosis risk score to identify ACS patients at high ischemic risk, we aim to investigate whether 3-month low-dose rivaroxaban therapy on the basis of dual antiplatelet therapy (DAPT) could result in reduced ischemic events without increasing bleeding. Design This study is a multi-center, prospective, open-label, randomized controlled trial involving 3,944 ACS patients undergoing PCI from more than 40 tertiary hospitals in China ([ClinicalTrials.gov][1] [NCT05638867][2]). Patients with PARIS coronary thrombosis score ≥ 3 and D-dimer ≥ 0.28μg/ml will be 1:1 randomized to experiment group (rivaroxaban 2.5mg twice daily for 3 months on the basis of one-year standard DAPT) or control group (one-year standard DAPT only). The primary endpoint of this study was Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), a composite of death, myocardial infarction, ischemia driven revascularization, stent thrombosis and systemic embolic events. The safety endpoint was BARC type 3 and 5 bleeding events. Summary In ACS patients with higher PARIS coronary thrombosis risk score and elevated D-dimer level, results of the PRIDE-ACS trial will reveal whether short-duration low-dose rivaroxaban can reduce MACCE events without increasing severe bleeding. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ClinicalTrials.gov [NCT05638867][2] ### Funding Statement The present study is supported by the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences (Grant No. NCRC2022003). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Institutional review board approval by the ethics committee of Fuwai Hospital was obtained on April 22, 2023 (Approval No. 2023-1980). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes No new data were generated or analysed in support of this research. [1]: https://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05638867&atom=%2Fmedrxiv%2Fearly%2F2023%2F08%2F02%2F2023.08.01.23293527.atom