Abstract
Background Aspirin is the first-line medication for prevention and treatment of coronary heart disease (CHD). However, long-term use of aspirin resulting in gastrointestinal mucosal injury and bleeding limits the regularity of medication. Xuesaitong is a marketed Chinese medicine contained main active component in Panax notoginseng saponins (PNS), which can significantly inhibit platelet aggregation in patients with CHD. Our previous studies have already showed that PNS could reduce the gastrointestinal mucosal injury caused by aspirin in preclinical study. However, there is a need for further clinical studies to evaluate synergy and attenuation effect of the combination. Methods This trial is a prospectively planned, open-labeled, parallel-grouped, single-centered clinical trial. A total of eligible 480 participants will be randomly allocated into three groups: aspirin group, Xuesaitong group, and drug combination group at a ratio of 1 : 1 : 1. The primary outcome is the change of platelet aggregation rate and calprotectin activity. Secondary outcomes include PAC-1, P-selectin, P2Y12, I-FABP activity, and fecal occult blood. Discussion. The results of the study are expected to provide evidence of high methodological and reporting quality on the synergy function of Xuesaitong and aspirin upon the antiplatelet and anti-gastrointestinal injury effect for CHD. It also provides an experimental basis for clinical rational drug combination therapy. Trial Registration. This trial was registered in the Chinese Clinical Trail Registry, ChiCTR2000036311, on 22 August 2020, http://www.chictr.org.cn/edit.aspx?pid=58798&htm=4.
Highlights
Coronary heart disease (CHD) is the leading cause of death worldwide, with more than 1.5 million deaths each year [1, 2]
Enteric-coated aspirin have been developed, 10%–25% long-term users still got peptic ulcers [4] and aspirin increases the risk of gastrointestinal bleeding by almost 3-fold [5]. ese side effects limit the regularity of medication which increases the risk of cardiovascular accidents. erefore, it is important to prevent the occurrence of aspirin-induced gastrointestinal injury
Our previous study has indicated that the combination could inhibit platelet activation caused by blood hypercoagulability and reduce platelet aggregation to prevent thrombosis [9, 10]. ese effects may rely on another finding from our team, which shows that aspirin and Xuesaitong could increase the area under the curve (AUC) and promote the absorption of each other [11, 12]
Summary
Aspirin is the first-line medication for prevention and treatment of coronary heart disease (CHD). Long-term use of aspirin resulting in gastrointestinal mucosal injury and bleeding limits the regularity of medication. Xuesaitong is a marketed Chinese medicine contained main active component in Panax notoginseng saponins (PNS), which can significantly inhibit platelet aggregation in patients with CHD. There is a need for further clinical studies to evaluate synergy and attenuation effect of the combination. E results of the study are expected to provide evidence of high methodological and reporting quality on the synergy function of Xuesaitong and aspirin upon the antiplatelet and anti-gastrointestinal injury effect for CHD. It provides an experimental basis for clinical rational drug combination therapy. Trial Registration. is trial was registered in the Chinese Clinical Trail Registry, ChiCTR2000036311, on 22 August 2020, http://www.chictr.org.cn/edit.aspx?pid 58798&htm 4
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