Clinical Trial on the Usefulness of an Intensive Low-Density Lipoprotein Cholesterol Treatment and Familial Hypercholesterolemia Screening Clinical Pathway for Acute Coronary Syndrome: The Hokuriku-plus Acute Coronary Syndrome Registry Study　― Rationale and Study Design ―

Abstract

Background: Acute coronary syndrome (ACS) is the critical situation caused by decreased blood flow of the coronary arteries. The most recent clinical guideline compiled by the Japanese Circulation Society (JCS) recommends lowering low-density lipoprotein cholesterol (LDL-C) to <70 mg/dL in patients with ACS, because of the lack of clinical evidence. It has been shown that there are substantial numbers of patients with familial hypercholesterolemia (FH) among ACS patients. On this basis, we intend assembling a multicenter registry to establish the evidence for lowering LDL-C <55 mg/dL while also clarifying the proportion of FH patients among Japanese ACS patients using a prespecified clinical pathway.

Methods and Results: The Hokuriku-plus ACS registry is a prospective, observational, multicenter cohort study, enrolling consecutive ACS patients from 14 participating hospitals in Hokuriku region of Japan from October 2025 to September 2027. A total of 1,000 patients will be enrolled followed over 1 year. The primary endpoint is the proportion of patients who attain LDL-C <55 mg/dL at 4 weeks. This study has been registered at the Japan Registry of Clinical Trials (jRCT1040250123).

Conclusions: We will disseminate the final results at international conferences and in a peer-reviewed journal.