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Combination of Xuesaitong and Aspirin Based on the Antiplatelet Effect and Gastrointestinal Injury: Study Protocol
Bao-Chen Zhu1, Chun-Miao Xue1, Rui Lang2
1Department of Pharmacy, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Insights
This clinical trial investigates the combined effects of aspirin and Xuesaitong (Panax notoginseng saponins) for coronary heart disease. The study aims to evaluate their synergistic antiplatelet and gastrointestinal protective benefits.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Gastroenterology
Background:
- Aspirin is a primary treatment for coronary heart disease (CHD) but can cause gastrointestinal issues.
- Xuesaitong, containing Panax notoginseng saponins (PNS), inhibits platelet aggregation and may reduce aspirin-induced gastrointestinal injury.
- Clinical evidence is needed to confirm the synergistic effects of combining Xuesaitong and aspirin.
Purpose of the Study:
- To evaluate the synergistic antiplatelet and gastrointestinal protective effects of combining Xuesaitong with aspirin in CHD patients.
- To provide evidence for rational drug combination therapy in CHD management.
Main Methods:
- A prospectively planned, open-labeled, parallel-grouped, single-centered clinical trial.
- 480 participants will be randomized into three groups: aspirin alone, Xuesaitong alone, and the combination.
- Primary outcomes include changes in platelet aggregation rate and calprotectin activity; secondary outcomes include PAC-1, P-selectin, P2Y12, I-FABP activity, and fecal occult blood.
Main Results:
- This section is to be filled upon study completion.
Conclusions:
- This study is expected to provide high-quality evidence on the combined efficacy of Xuesaitong and aspirin.
- Results will support the clinical application of this drug combination for CHD treatment and prevention.
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.
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