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NCT Number: NCT07068490

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine use of P-CAB on DAPT

Drug

This group received P-CAB with DAPT after PCI.

Guideline Directed Medical Therapy

Drug

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

Primary outcomes

  1. Major GI bleeding

    Time frame: at 1 year

    Major GI bleeding requiring transfusion

Secondary outcomes

  1. Clinically relevant GI bleeding

    Time frame: At 1 year

    Clinically relevant GI bleeding

  2. Major adverse cardiac event

    Time frame: At 1 year

    A composite of cardiovascular death, myocardial infarction, and repeat revascularization

  3. Cardiovascular death

    Time frame: At 1 year

    Cardiovascular death

  4. Myocardial infarction

    Time frame: At 1 year

    Myocardial infarction

  5. Repeat revascularization

    Time frame: At 1 year

    Repeat revascularization

Study contacts

Contact information is provided by the study sponsor or research team.

Danbee Kang, PhD

CONTACT

[email protected]

82-2-2148-7197

Ki Hong Choi, MD, PhD

CONTACT

[email protected]

82-2-3410-3419

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: PCAB-PCI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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