Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall ST-Segment Elevation Myocardial Infarction (CODE-AAMI): Protocol for a Randomized Placebo-Controlled Trial.

BACKGROUND: Ventricular remodeling after acute anterior wall ST-segment elevation myocardial infarction (AAMI) is an important factor in occurrence of heart failure which additionally results in poor prognosis. Therefore, the treatment of ventricular remodeling needs to be further optimized. Compound Danshen Dripping Pills (CDDP), a traditional Chinese medicine, exerts a protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and attenuates ventricular remodeling after myocardial infarction. OBJECTIVE: This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI on a larger scale. METHODS: This study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The total of 268 patients with AAMI after primary percutaneous coronary intervention (pPCI) will be randomly assigned 1:1 to the CDDP group (n=134) and control group (n=134) with a follow-up of 48 weeks. Both groups will be treated with standard therapy of ST-segment elevation myocardial infarction (STEMI), with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets 3 times daily after pPCI, and the control group treated with a placebo simultaneously. The primary endpoint is 48-week echocardiographic outcomes including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), and left ventricular end-systolic volume index (LVESVI). The secondary endpoint includes the change in N terminal pro-B-type natriuretic peptide (NT-proBNP) level, arrhythmias, and cardiovascular events (death, cardiac arrest, or cardiopulmonary resuscitation, rehospitalization due to heart failure or angina pectoris, deterioration of cardiac function, and stroke). Investigators and patients are both blinded to the allocated treatment. DISCUSSION: This prospective study will investigate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function in patients undergoing pPCI for a first AAMI. Patients in the CDDP group will be compared with those in the control group. If certified to be effective, CDDP treatment in AAMI will probably be advised on a larger scale. (Trial registration No. NCT05000411).

White blood cell count combined with LDL cholesterol as a valuable biomarker for coronary artery disease.

OBJECTIVE: Inflammation and dyslipidemia are important pathophysiological bases for the occurrence and development of coronary artery disease (CAD); however, combination of these two entities is rarely used to diagnose CAD and its severity. Our aim was to determine whether the combination of white blood cell count (WBCC) and LDL cholesterol (LDL-C) can serve as a biomarker for CAD. METHODS: We enrolled 518 registered patients and measured serum WBCC and LDL-C on admission. The clinical data were collected, and the Gensini score was used to assess the severity of coronary atherosclerosis. RESULTS: WBCC and LDL-C levels in the CAD group were higher than in the control group ( P  < 0.01). Spearman correlation analysis showed that WBCC combined with LDL-C was positively correlated with the Gensini score ( r  = 0.708, P  < 0.01) and the number of coronary artery lesions ( r  = 0.721, P  < 0.01). Receiver operating characteristic curve analysis revealed that WBCC combined with LDL-C had a higher predictive value for CAD, severe CAD, and three-vessel CAD [area under the curve (AUC) values were 0.909, 0.867, and 0.811, respectively] than WBCC (AUC values were 0.814, 0.753, 0.716, respectively) and LDL-C (AUC values were 0.779, 0.806, 0.715, respectively) alone (all P  < 0.05). CONCLUSION: WBCC combined with LDL-C is correlated with the degree of coronary artery lesion. It had high sensitivity and specificity in the diagnosis of CAD, severe CAD, and three-vessel CAD.

Determination of rivaroxaban in rat plasma by ultra-high-performance liquid chromatography-Q-Orbitrap high-resolution mass spectrometry and its application to a pharmacokinetic study.

Therapeutic drug monitoring is critical to decrease the incidence rate of bleeding and thrombosis for personalized treatment with rivaroxaban, especially for drug interaction treatment, patients with renal dysfunction, elderly patients, patients with cardiovascular problems, and so on. In addition, an accurate analytical method is necessary for therapeutic drug monitoring. This study developed a ultra-HPLC-tandem Orbitrap high-resolution MS (UHPLC-Q-Orbitrap HRMS) method to accurately identify and quantify rivaroxaban in rat plasma. The isotope internal standard method was applied for accurate quantification. Rivaroxaban-d4 was selected as the isotope internal standard substance. The m/z 436.07263 ([M + H]+ ) was selected as the precursor ion and m/z 144.95085 and m/z 231.11259 were selected as the main product ions for rivaroxaban. The lower limit of quantification of rivaroxaban in plasma was 0.01 mg/L. The intra- and inter-day precisions were ≤3.65% and ≤8.16%, while the recoveries ranged from 87.4% to 95.2%. This analysis method was simple, low cost, and easy to operate. The developed and validated method was subsequently applied to successfully investigate the pharmacokinetic parameters of rivaroxaban in rats after its oral administration. These results could be helpful to promote further research regarding the mechanisms of rivaroxaban and drug interaction, which can avoid false positives due to high-precision identification of the proposed method.

Application value of whole-course health management for patients with nonvalvular atrial fibrillation with oral warfarin treatment.

OBJECTIVE: To explore the effect of the whole-process health management model on the compliance of oral warfarin treatment in patients with non-valvular atrial fibrillation in primary hospitals. METHODS: We retrospectively analyzed the clinical data of 130 patients with non-valvular atrial fibrillation treated in the Department of Cardiovascular Medicine, Hai'an People's Hospital from January 2019 to December 2019. Among them, 63 patients who received routine continuing care were included in the control group, and 67 patients treated with whole-course health management model of primary hospitals were included in the observation group. The two groups were compared in terms of the following parameters: Warfarin anticoagulation knowledge, medication compliance, compliance rate (international normalized ratio, INR) monitoring, bleeding events (gingival bleeding, subcutaneous bleeding, gastrointestinal bleeding, etc.), embolic events (vascular thrombosis), negative emotions before and after management, and patient satisfaction. Logistic analysis was used to analyze independent risk factors affecting the effect of warfarin anticoagulation in patients with non-valvular atrial fibrillation. RESULTS: Compared with the control group, the warfarin anticoagulation knowledge, medication compliance, and INR compliance rate of the observation group were significantly higher, and the incidence of adverse events was significantly lower. Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) scores were not significantly different between the two groups before management. After management, SAS and SDS scores decreased significantly in both groups, and were lower in the observation group compared with the control group. The management satisfaction was also significantly higher in the observation group. CONCLUSION: Compared with the conventional continuation care model, the whole-process management in primary hospitals can improve patients' compliance with medical advice and treatment efficacy, with lower risk of bleeding and higher patient satisfaction, providing a better option for the out-of-hospital management of anticoagulation for non-valvular atrial fibrillation patients. Age, hypertension, diabetes, knowledge of warfarin anticoagulation and medication compliance were independent risk factors for the effect of warfarin anticoagulation in patients with non-valvular atrial fibrillation.