Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronary intervention: study protocol for a non-inferiority randomized controlled trial

Abstract

Abstract

Background

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y₁₂ inhibitor is recommended for patients with coronary heart disease (CHD) undergoing percutaneous coronary intervention (PCI) to antithrombosis, meanwhile, increasing the risks of gastrointestinal bleeding. Rivaroxaban, a novel oral anticoagulant, combined with a P2Y₁₂ receptor inhibitor reduces adverse events in patients with CHD and atrial fibrillation who underwent PCI. The effect of rivaroxaban plus P2Y₁₂ inhibitor on reducing bleeding events in patients with CHD and gastrointestinal disease (GID) undergoing PCI remains unclear.

Method

The study is a prospective, single-center, randomized controlled trial. A total of 1020 patients with CHD and GID undergoing PCI will be enrolled. Patients are randomized (1:1) to receive either rivaroxaban 10 mg plus clopidogrel 75 mg daily or aspirin 100 mg plus clopidogrel 75 mg daily; both treatments will last 6 months. The primary endpoint is Bleeding Academic Research Consortium (BARC) type 2–5 bleeding requiring medical intervention. The secondary endpoint is a composite of major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization, and stroke.

Discussion

The objective of this study is to evaluate the efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with CHD and GID undergoing PCI. We aim to explore an optimized antithrombotic strategy, which achieves the same anti-ischemic effect as standard DAPT without increasing the risk of GIB, for patients with CHD and GID undergoing PCI.

Trial registration

This protocol is registered at the Chinese Clinical Trial Registry under the number ChiCTR2100044319. And this publication is based on version 1.4 of the trial protocol dated Sep 6, 2021.

Highlights

1. To find a more appropriate antithrombotic strategy for patients with CHD and GID undergoing PCI.

2. To identify whether rivaroxaban can reduce the bleeding risk of the gastrointestinal tract compared with aspirin.