Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies I… (NCT04416581) | Clinical Trial Compass
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
South Korea3,320 participantsStarted 2021-05-12
Plain-language summary
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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients 19 years of age or older with known cardiac and vascular disease who are receiving chronic use of antithrombotic drugs (either antiplatelets, oral anticoagulant (OAC), and its combinations). Specific clinical conditions that may confer a need for long-term antithrombotic therapy may include documented coronary artery disease (stable or unstable angina, acute coronary syndrome, a history of myocardial infarction, or any coronary revascularization), documented cerebrovascular disease (stroke or transient ischemic attack), known peripheral arterial disease or a history of peripheral arterial revascularization, atrial fibrillation, or valvular heart disease requiring interventions (transcatheter aortic valve replacement or transcatheter mitral-valve repair). Concomitant use of a proton pump inhibitor is strongly recommended in patients receiving aspirin monotherapy, DAPT (dual antiplatelet therapy; aspirin plus any P2Y12 inhibitors), DAT (dual antithrombotic therapy; antiplatelet drug plus OAC), TAT (triple antithrombotic therapy; DAPT plus OAC), or OAC monotherapy (warfarin or direct oral anticoagulants) who are at high risk of GI bleeding in order to reduce the risk of gastric bleed or GI events. Based on clinical guidelines, the use of P2Y12 inhibitor monotherapy (i.e. clopidogrel, ticagrelor, or prasugrel) is not considered in trial enrollment.
. On the basis of clinical guidelines and expert consensus documents, we defined a study population with an increased risk of gastrointestinal bleeding if they had a least 1 or more criteria of the following characteristics. Eligible patients for randomization must meet at least 1 characteristic of these criteria:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a newer type of acid blocker called a potassium-competitive acid blocker to the more familiar proton-pump inhibitors — can you explain how these two types of stomach protection differ, and whether one might be a better fit for my situation given that I'm on antithrombotic therapy?
2Since I'm being treated for a heart condition like coronary artery disease or a recent acute coronary syndrome, and antithrombotic drugs can raise my bleeding risk, how concerned are you about my personal GI bleeding risk, and is joining a trial like this a reasonable way to address it compared to just sticking with standard care?
3This is a Phase 4 trial, which means both medications involved are already approved — does that change what we know about their safety profiles, and are there still meaningful unknowns that make participating in this study a consideration worth discussing?
4The trial is currently recruiting, so if I were interested, what would participation actually look like day-to-day — how often would I need to come in, how long would I be followed, and how would it fit around my existing cardiology care?
5If I don't join this trial, what stomach-protective strategy would you recommend for me while I'm on antithrombotic therapy, and is there a meaningful difference in what I'd receive inside versus outside the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The time from randomization to the first occurrence of a composite endpoint of upper GI clinical events, including during the treatment period
. Concomitant use of OAC and any antiplatelet therapy (mono or DAPT) (i.e., DAT or TAT)
. Long-term use of oral NSAIDs (non-steroidal anti-inflammatory drugs) or steroids or high-dose NSAID therapy even during a relatively short-term period.
. History of prior GI bleeding events at any time
. History of a previously complicated ulcer
. History of peptic ulcer disease or a previously uncomplicated ulcer
Exclusion criteria
. Active bleeding at the time of inclusion or a history of hereditary or acquired hemostatic disorder
. Any clinical contraindication to using of antithrombotic therapies (antiplatelet agents or OAC)
. Concurrent use of PPI or P-CAB within 4 weeks before randomization
. Hemodynamically unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV).
. Baseline severe anemia (Hgb \<8 g/dl at baseline) or transfusion within 4 weeks before randomization
. Baseline severe thrombocytopenia (platelet count \<50,000/mm3)
. Renal failure dependent on dialysis or severe renal insufficiency (creatinine clearance \<15 ml/min)
. Severe chronic liver disease (defined as variceal haemorrhage, ascites, hepatic encephalopathy, or jaundice)