Dataset Information

A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Taoren Honghua Jian granule in patients with stable coronary artery disease.

ABSTRACT:

Introduction

Stable coronary artery disease (SCAD) is a common clinical style in patients with coronary artery disease. Inflammation and immune injury in SCAD have been proven. Current interventions can relieve patients' symptoms, but none are stable to improve the immune damage significantly. Chinese herb is used to treat stable angina pectoris as an alternative therapy. Taoren Honghua Jian granule (THJG) is a classical formula from which patients can benefit, but lack convincing evidence. Therefore, we report a protocol of high-quality randomized controlled trial.

Methods/design

We will conduct a randomized, double-blind, placebo-controlled clinical trial to assess the effect of THJG in relief of symptoms and blood immune indexes. A total of 80 patients with SCAD will be enrolled, and treated with THJG or placebo for 4 weeks. The primary outcome measurement is change of integral traditional Chinese medicine (TCM) syndrome score from baseline to 4 weeks' treatment. The 2nd outcome measurements include change of integral TCM syndrome scores from baseline to 2 weeks' treatment and another 4 weeks' follow-up, inflammation indexes at baseline and 4 weeks' treatment. It also includes Seattle Angina Questionnaire, major adverse cardiovascular events, Athens Insomnia scale, and 36-item short form health survey score from baseline to 2 weeks' and 4 weeks' treatment, and another 4 weeks' follow-up. Adverse events will be evaluated throughout the trial.

Discussion

The results of this trial will prove whether THJG could alleviate symptoms, control inflammation, and improve quality of life in patients with SCAD.

Trial registration

ChiCTR1900021772, registered 8 March, 2019.

SUBMITTER: Wang Y

PROVIDER: S-EPMC6946464 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Taoren Honghua Jian granule in patients with stable coronary artery disease.

Wang Yiru Y Zhang Yiyi Y Du Yiyue Y Yang Ying Y Wei Jing J Zhang Na N Mao Meijiao M Du Wenting W Liu Ping P

Medicine 20191101 44

<h4>Introduction</h4>Stable coronary artery disease (SCAD) is a common clinical style in patients with coronary artery disease. Inflammation and immune injury in SCAD have been proven. Current interventions can relieve patients' symptoms, but none are stable to improve the immune damage significantly. Chinese herb is used to treat stable angina pectoris as an alternative therapy. Taoren Honghua Jian granule (THJG) is a classical formula from which patients can benefit, but lack convincing eviden ...[more]

PMID: 31689832

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Project description:AimsThe effects of serelaxin, a recombinant form of human relaxin-2 peptide, on vascular function in the coronary microvascular and systemic macrovascular circulation remain largely unknown. This mechanistic, clinical study assessed the effects of serelaxin on myocardial perfusion, aortic stiffness, and safety in patients with stable coronary artery disease (CAD).Methods and resultsIn this multicentre, double-blind, parallel-group, placebo-controlled study, 58 patients were randomized 1:1 to 48 h intravenous infusion of serelaxin (30 µg/kg/day) or matching placebo. The primary endpoints were change from baseline to 47 h post-initiation of the infusion in global myocardial perfusion reserve (MPR) assessed using adenosine stress perfusion cardiac magnetic resonance imaging, and applanation tonometry-derived augmentation index (AIx). Secondary endpoints were: change from baseline in AIx and pulse wave velocity, assessed at 47 h, Day 30, and Day 180; aortic distensibility at 47 h; pharmacokinetics and safety. Exploratory endpoints were the effect on cardiorenal biomarkers [N-terminal pro-brain natriuretic peptide (NT-proBNP), high-sensitivity troponin T (hsTnT), endothelin-1, and cystatin C]. Of 58 patients, 51 were included in the primary analysis (serelaxin, n = 25; placebo, n = 26). After 2 and 6 h of serelaxin infusion, mean placebo-corrected blood pressure reductions of -9.6 mmHg (P = 0.01) and -13.5 mmHg (P = 0.0003) for systolic blood pressure and -5.2 mmHg (P = 0.02) and -8.4 mmHg (P = 0.001) for diastolic blood pressure occurred. There were no between-group differences from baseline to 47 h in global MPR (-0.24 vs. -0.13, P = 0.44) or AIx (3.49% vs. 0.04%, P = 0.21) with serelaxin compared with placebo. Endothelin-1 and cystatin C levels decreased from baseline in the serelaxin group, and there were no clinically relevant changes observed with serelaxin for NT-proBNP or hsTnT. Similar numbers of serious adverse events were observed in both groups (serelaxin, n = 5; placebo, n = 7) to 180-day follow-up.ConclusionIn patients with stable CAD, 48 h intravenous serelaxin reduced blood pressure but did not alter myocardial perfusion.

Dataset Information

A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Taoren Honghua Jian granule in patients with stable coronary artery disease.

Introduction

Methods/design

Discussion

Trial registration

Publications

A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Taoren Honghua Jian granule in patients with stable coronary artery disease.

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