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

NCT07068490 | Recruiting

• 1 other identifier: PCAB_TTE
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

percutaeneous coronary intervention; dual antiplatelet therapy; gastrointestinal protection

Outcome Measures

Primary Outcomes (1)

• Major GI bleeding

  Major GI bleeding requiring transfusion

  at 1 year

Secondary Outcomes (5)

• Clinically relevant GI bleeding

  At 1 year

• Major adverse cardiac event

  At 1 year

• Cardiovascular death

  At 1 year

• Myocardial infarction

  At 1 year

• Repeat revascularization

  At 1 year

Study Arms (2)

Routine use of P-CAB

All-comer patients with P-CAB

Drug: Routine use of P-CAB on DAPT

Guideline-directed GI protection strategy

Use of PPI or not according to GI bleeding risk

Drug: Guideline Directed Medical Therapy

Interventions

Routine use of P-CAB on DAPT DRUG

This group received P-CAB with DAPT after PCI.

Routine use of P-CAB

Guideline Directed Medical Therapy DRUG

This group received PPI or not with DAPT after PCI according to GI bleeding risk.

Guideline-directed GI protection strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with coronary artery disease who underwent PCI

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• KI HONG CHOI, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Hong Choi, MD, PhD

CONTACT

82-2-3410-3419; cardiokh@gmail.com

Danbee Kang, PhD

CONTACT

82-2-2148-7197; dbee.kang@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 16, 2025
• Study Start: October 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

KR (1)