Randomised controlled trial of early magnetically controlled capsule endoscopy for the prevention of gastrointestinal bleeding in patients at high bleeding risk scheduled for percutaneous coronary intervention: MACE-GPS study protocol.

INTRODUCTION

Limited data are available regarding the decision-making process for preventing gastrointestinal bleeding in patients at high risk of bleeding scheduled for percutaneous coronary intervention (HBPCI), especially due to the lack of a simple, accurate and sensitive methods for gastrointestinal injury detection. This randomised trial aims to assess the effects of early magnetically controlled capsule endoscopy (MCE) in patients with HBPCI for the prevention of gastrointestinal bleeding compared with conventional management.

METHODS AND ANALYSIS

The Magnetic-Assisted Capsule Endoscopy Gastrointestinal bleeding Protection Strategy (MACE-GPS) is a multicentre, open-label, randomised controlled trial. Patients admitted for HBPCI will be randomised and placed into two study groups. In the early MCE group, 1228 patients will undergo MCE following admission to the hospital. If necessary, these patients may further undergo a multidisciplinary approach to determine treatment based on the MCE findings. A total of 1228 patients in the control group will undergo conventional treatment based on the attending cardiologist's interpretation of their clinical presentations. The primary end point is the incidence of gastrointestinal bleeding within 12 months of enrolment.

ETHICS AND DISSEMINATION

The MACE-GPS trial has been approved by the ethics committees of all participating sites. Participant recruitment began in April 2023 and will be completed in April 2025, and the 1-year follow-up will be completed in April 2026. The study results will be disseminated through conference presentations and peer-reviewed publications.

TRIAL REGISTRATION NUMBER

ChiCTR2300070025.