Impact of Potassium Competitive Acid Blockers After Percutaneous Coronary Intervention for Efficacy and Safety Outcome: Target Trial Emulation Study. (PCAB-PCI)

Samsung Medical Center

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Drug: Guideline Directed Medical Therapy; Drug: Routine use of P-CAB on DAPT

Study type: Observational

Funder types: Other

Identifiers

NCT07068490

PCAB_TTE

Details and patient eligibility

About

Despite the fact that potassium competitive acid blocker (P-CAB) has been developed for the treatment of gastric ulcer or gastroesophageal reflux disease, the efficacy and safety of P-CAB for the use of gastrointestinal (GI) protection in patients undergoing percutaneous coronary intervention (PCI) and maintaining dual antiplatelet therapy (DAPT) remains uncertain.

Full description

To evaluate the efficacy and safety of routine P-CAB use in patients with coronary artery disease who underwent PCI and maintain DAPT, as compared to guideline-directed proton pump inhibitor (PPI) usage.

Enrollment: 100,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent PCI
• Use of either clopidogrel, prasugrel, or ticagrelor in combination with aspirin
• No use of PCAB, PPI, or an H2-receptor within the past month

Exclusion criteria

• Patients with low GI bleeding risk are taken on PPI
• Patients with high GI bleeding risk do not take PPI

Trial design

100,000 participants in 2 patient groups

Routine use of P-CAB

Description:

All-comer patients with P-CAB

Treatment:

Drug: Routine use of P-CAB on DAPT

Guideline-directed GI protection strategy

Description:

Use of PPI or not according to GI bleeding risk

Treatment:

Drug: Guideline Directed Medical Therapy