Actively Recruiting
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Led by Duk-Woo Park, MD · Updated on 2025-12-30
3320
Participants Needed
43
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.
CONDITIONS
Official Title
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older with known cardiac and vascular disease using chronic antithrombotic therapy
- Patients at high risk of gastrointestinal bleeding with at least one of the following: age 65 or older, combined use of oral anticoagulants and antiplatelet therapy, long-term or high-dose NSAIDs or steroids, history of prior GI bleeding, complicated or uncomplicated ulcers, or documented Helicobacter pylori infection
- Patients who voluntarily agree in writing to participate
You will not qualify if you...
- Active bleeding or history of bleeding disorders
- Contraindications to antithrombotic therapy
- Use of proton pump inhibitors or P-CAB within 4 weeks before randomization
- Hemodynamically unstable conditions such as cardiogenic shock or severe heart failure
- Severe anemia (hemoglobin <8 g/dl) or recent blood transfusion
- Severe thrombocytopenia (platelets <50,000/mm3)
- Renal failure requiring dialysis or severe kidney insufficiency
- Severe chronic liver disease
- Allergies or contraindications to study drugs or related compounds
- Use of certain antibiotics or drugs with significant interactions
- Significant laboratory abnormalities or conditions precluding participation
- Known or suspected cancer
- Non-cardiac illnesses with life expectancy under 12 months
- Active treatment for H. pylori infection
- Pregnancy, breastfeeding, or inadequate birth control in women of childbearing potential
- Participation in another clinical study within the past 12 months, with some exceptions
AI-Screening
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Trial Site Locations
Total: 43 locations
1
Hallym University Sacred Heart Hospital
Anyang, South Korea
Actively Recruiting
2
Bucheon Sejong Hospital
Bucheon-si, South Korea
Actively Recruiting
3
Kosin University Gospel Hospital
Busan, South Korea
Actively Recruiting
4
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Withdrawn
5
Sungkyunkwan University Samsung Changwon Hospital
Changwon, South Korea
Withdrawn
6
Dankook University Hospital
Cheonan, South Korea
Withdrawn
7
Chungbuk National University Hospital
Cheonju, South Korea
Actively Recruiting
8
Gangwon National Univ. Hospital
Chuncheon, South Korea
Withdrawn
9
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
Not Yet Recruiting
10
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
11
Yeungnam University Medical Center
Daegu, South Korea
Withdrawn
12
Chungnam National University Hospital
Daejeon, South Korea
Actively Recruiting
13
Gangneung Asan Hospital
Gangneung, South Korea
Actively Recruiting
14
Hanyang University Guri Hospital
Guri-si, South Korea
Actively Recruiting
15
Chonnam National University Hospital
Gwangju, South Korea
Actively Recruiting
16
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, South Korea
Actively Recruiting
17
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Actively Recruiting
18
Jeonbuk National University Hospital
Jeonju, South Korea
Withdrawn
19
Kwangju Christian Hospital
Kwangju, South Korea
Withdrawn
20
Dong-A Medical Center
Pusan, South Korea
Actively Recruiting
21
Inje University Pusan Paik Hospital
Pusan, South Korea
Actively Recruiting
22
Pusan National University Hospital
Pusan, South Korea
Not Yet Recruiting
23
Chungnam National University Sejong Hospital
Sejong, South Korea
Actively Recruiting
24
Bundang CHA Hospital
Seongnam, South Korea
Actively Recruiting
25
Seoul university Bundang hospital
Seongnam-si, South Korea
Actively Recruiting
26
Asan Medical Center
Seoul, South Korea
Actively Recruiting
27
Chung-Ang University Hospital
Seoul, South Korea
Actively Recruiting
28
Ewha Womans University Medical Center
Seoul, South Korea
Withdrawn
29
Hanyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
30
Kangbuk Samsung Hospital
Seoul, South Korea
Actively Recruiting
31
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
32
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Actively Recruiting
33
Kyung Hee University Medical Center
Seoul, South Korea
Actively Recruiting
34
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
35
Severance Hospital
Seoul, South Korea
Actively Recruiting
36
SNU Boramae Medical Center
Seoul, South Korea
Not Yet Recruiting
37
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
Seoul, South Korea
Actively Recruiting
38
The Catholic Univ. of Korea Seoul St. Mary's hospital
Seoul, South Korea
Actively Recruiting
39
Ajou University Hospital
Suwon, South Korea
Actively Recruiting
40
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, South Korea
Actively Recruiting
41
Ulsan University Hospital
Ulsan, South Korea
Actively Recruiting
42
Pusan National University Yangsan Hospital
Yangsan, South Korea
Withdrawn
43
Yonsei University Yongin Severance Hospital
Yongin-si, South Korea
Actively Recruiting
Research Team
J
Jeong-youn Bae, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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