NCT04805710

Rivaroxaban or Aspirin in Patients With CHD & GD Undergoing PCI

The Efficacy and Safety of Clopidogrel Combined With Rivaroxaban and Aspirin in Patients With Coronary Heart Disease and Gastrointestinal Diseases Undergoing PCI：a Randomized Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: Shenyang Northern Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy and safety of rivaroxaban or aspirin combined with clopidogrel in patients with coronary heart disease and gastrointestinal diseases undergoing PCI.

Detailed description

Background：Aspirin combined with P2Y12 receptor antagonist are the antithrombotic basis of percutaneous coronary intervention (PCI) for coronary heart disease. Guidelines at home and abroad recommend that patients with stable coronary heart disease need double antiplatelet therapy for 6 months, and patients with acute coronary syndrome need double antiplatelet therapy for 12 months to prevent stent thrombosis and reduce the risk of ischemic or atherosclerotic thrombosis events, including stent thrombosis, recurrent myocardial infarction and cardiogenic death. Aspirin can inhibit the activity of cyclooxygenase in gastrointestinal tract, causing gastrointestinal mucosal epithelial injury and bleeding. For patients with gastrointestinal diseases, the risk of bleeding is higher after taking aspirin for a long time. 48.7% of PCI patients suffered from bleeding in digestive tract, so it is very important to protect gastrointestinal mucosa. In the past, patients with coronary heart disease who were accompanied by gastrointestinal diseases and could not tolerate aspirin often delayed PCI or conservative treatment with drugs, and the prognosis was very poor. In the study of patients with coronary heart disease complicated with atrial fibrillation undergoing PCI, it is concluded that the bleeding rate in the clopidogrel combined with rivaroxaban group is lower and the curative effect is not inferior to that of triple antithrombotic regimen. Whether rivaroxaban can replace aspirin for coronary heart disease complicated with gastrointestinal diseases has no research evidence and no relevant guidelines. Methods:Patients who have been selected will be randomized to the clopidogrel combined with rivaroxaban arm versus the clopidogrel combined with aspirin arm. Patients selected in the clopidogrel combined with rivaroxaban arm will receive clopidogrel 75 mg once daily and rivaroxaban 10 mg once daily. Patients selected in the clopidogrel combined with aspirin arm will receive clopidogrel 75 mg once daily and aspirin 100 mg once daily. The therapy will last for at least six months in the both arms. The primary endpoints will be evaluated at six-months follow-up.

Conditions

• Rivaroxaban

Interventions

Type	Name	Description
DRUG	clopidogrel combined with rivaroxaban arm	Patients who have been selected will be randomized to the clopidogrel combined with rivaroxaban arm. clopidogrel 75 mg once daily and rivaroxaban 10 mg once daily

Timeline

• Start date: 2021-03-17
• Primary completion: 2022-09-16
• Completion: 2023-12-31
• First posted: 2021-03-18
• Last updated: 2021-03-18