Effect of intelligent hypertension management system on blood pressure: protocol for a randomised controlled multicentre trial.

INTRODUCTION: Hypertension is one of the most serious global health problems, and its prevention and treatment mainly rely on lifestyle intervention and medication. However, the current situation of hypertension control in China is still not ideal. Self-monitoring of blood pressure is expected to be a new way to control hypertension. Intervention and the Intelligent Hypertension Management System (IHMS), an information platform relying on the network and smartphone, may help patients self-monitor their blood pressure at home, allowing for intelligent management of hypertension. The aim of this trial is to investigate whether IHMS can effectively reduce blood pressure in patients with hypertension. METHODS AND ANALYSIS: This is a multiple-centre, prospective, randomised, controlled study. 320 eligible subjects will be randomly divided into the IHMS management group (n=160) and the conventional care group (n=160). Subjects in the IHMS management group will be required to take their blood pressure daily at regular intervals at home and get treatment as directed by the IHMS; the control group will receive conventional treatment. The primary outcome of the trial is the net change in systolic blood pressure at the end point of follow-up after 3 months. The mixed-effects model will be used to compare the primary outcome that there is a greater reduction in blood pressure in the intervention group than in the control group. ETHICS AND DISSEMINATION: The Ethics Committee of Shanghai Tongren Hospital has reviewed and approved the trial protocols, informed consent and subject information. The findings from the study will be disseminated through publications and conference presentations. The findings of the trial will be published in journals and presented at academic conferences. TRIAL REGISTRATION NUMBER: NCT05526300.

Impact of early PCSK9 inhibitor treatment on heart after percutaneous coronary intervention in patients with STEMI: Design and rationale of the PERFECT II trial.

Background and aims: Primary percutaneous coronary intervention (PPCI) is the most effective treatment strategy for ST-segment elevation myocardial infarction (STEMI). Nevertheless, dysregulated inflammation induced by myocardial reperfusion injury may increase the final infarct size and induce maladaptive myocardial remodeling. Proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor, as a novel and potent lipid-lowering drug, plays an important role in inflammation. The aim of this study is to investigate whether the early application of PCSK9 inhibitor can increase the myocardial salvage index (MSI) and improve ventricular remodeling in patients with STEMI. Design: The PERFECT II trial is a prospective, open-label, multicenter, randomized controlled study involving 160 patients with STEMI who are scheduled to undergo PPCI. The eligible patients will be divided into PCSK9 inhibitor group and control group via the interactive web response system, at a 1:1 ratio. In the PCSK9 inhibitor group, the PCSK9 inhibitor alirocumab at a dose of 75 mg will be subcutaneously injected immediately after PPCI and administered every 2 weeks thereafter for 3 months based on conventional treatment. In the control group, conventional treatment will be administered. The primary endpoint is MSI, as measured by cardiac magnetic resonance imaging (CMR) at 1 week after PPCI. The secondary endpoints are the peak time of creatine kinase (CK)-MB and troponin I (TnI)/TnT after PPCI; the postoperative fall time of the ST segment on electrocardiography (ECG); the rate of plasma low-density lipoprotein cholesterol (LDL-C) compliance (< 1.4 mmol/L and a reduction of >50% from baseline) at 1, 3, and 6 months after PPCI; infarct size and ejection fraction (EF) measured by CMR at 6 months after PPCI; the occurrence of major adverse cardiovascular event (MACE: a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, repeat revascularization, stroke, and heart failure needed to be hospitalized). Conclusions: This is the first multicenter study to investigate the effect of early application of the PCSK9 inhibitor alirocumab on MSI in patients with STEMI undergoing PPCI. The findings will provide an opportunity to explore novel ideas and methods for the treatment of acute myocardial infarction. Trial registration: ClinicalTrials.gov, identifier: NCT05292404.

A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY.

BACKGROUND: Current guidelines recommend that patients with acute coronary syndrome (ACS) who have successfully undergone percutaneous coronary intervention (PCI) should continue to use dual antiplatelet therapy (DAPT) for 12 months. The long-term use of standard-dose dual antiplatelet therapy will increase the risk of bleeding. An optimized antiplatelet strategy that can prevent ischemic events and reduce the risk of bleeding remains to be explored. METHODS: The study is a prospective, multicenter, randomized, open-label, controlled study involving 2090 patients from six clinical centers in China. Through the interactive web response system (IWRS), ACS patients undergoing successful PCI will be randomly divided into the low-dose ticagrelor group or the normal-dose ticagrelor group, after taking 100 mg aspirin and 90 mg ticagrelor bid for 1 week. The primary endpoint is a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, repeat revascularization, and stroke. The secondary endpoints are bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria, cardiovascular death, acute myocardium infarction, and coronary revascularization at 1 year. DISCUSSION: Recent studies have confirmed that 90 mg ticagrelor alone can safely and effectively reduce bleeding without increasing ischemic events of patients with ACS after PCI. Compared with standard-dose DAPT, whether low-dose ticagrelor combined with aspirin can ensure the anti-ischemic effect while reducing the bleeding risk remains unclear in Chinese patients. The TIGER study will be the first large-scale, multicenter study to compare the efficacy and safety of low-dose and standard-dose ticagrelor combined with aspirin in ACS patients 1 week after successful PCI. TRIAL REGISTRATION: Clinicaltrials.gov NCT04255602. Registered on 5 February 2020.