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Compares treatment options for Coronary Artery Disease
Official title Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
ClinicalTrials.gov ID: NCT04416581
What this study is testing
What is PPI?
PPI is an investigational medicine, given as an once-daily, being studied as a potential treatment for coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Patients 19 years of age or older with known cardiac and vascular disease who are receiving chronic use of antithrombotic drugs (either...
- On the basis of clinical guidelines and expert consensus documents, we defined a study population with an increased risk of gastrointestinal bleeding...
- Age ≥65 years
- 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...
You likely can't join if
- 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...
- Baseline severe anemia (Hgb \<8 g/dl at baseline) or transfusion within 4 weeks before randomization
- Baseline severe thrombocytopenia (platelet count \<50,000/mm3)
See the full eligibility 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...
- 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...
- Age ≥65 years
- 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
- Documented Helicobacter pylori infection
- Patients who voluntarily participated in the written agreement
- 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)
- Hypersensitivity or contraindication to PPI, P-CAB, any of the product components, or substituted benzimidazoles
- Use of clarithromycin and hypersensitivity to macrolide antibiotics for Helicobacter pylori eradication
- Concomitant use of clarithromycin with terfenadine, cisapride, astemizole, or pimozide for Helicobacter pylori eradication
- Systemic treatment with strong CYP 3A4 and p-glycoprotein (P-GP) inhibitors (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir)
- Patients who take atazanavir, nelfinavir, or rilpivirine-containing products (see Drug-Drug interaction section)
- Clinically significant laboratory abnormality at screening (estimated glomerular filtration rate (eGFR) \ 3 times upper normal limit [UNL] or any other condition that, in the opinion of the Investigator, precludes...
- Any known or suspected malignancy
- Patients with non-cardiac co-morbidities with a life expectancy of less than 12 months
- Patients with active treatment for H-pylori infection
- Women who are pregnant or breastfeeding or female people, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives...
- Participation in another clinical study within 12 months. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;
- Participated in the observational study expected no effect on the safety and/or how well it works evaluation of this trial
- Screening failed before any treatment factor is involved
- Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference...
The study team makes the final eligibility decision.
Where it's taking place
- Anyang, South Korea
- Bucheon-si, South Korea
- Busan, South Korea
- Changwon, South Korea
- Cheonan, South Korea
- Cheonju, South Korea
- Chuncheon, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Gangneung, South Korea
- Guri-si, South Korea
- Gwangju, South Korea
- Hwaseong-si, South Korea
- Ilsan, South Korea
- Jeonju, South Korea
- Kwangju, South Korea
- Pusan, South Korea
- Sejong, South Korea
- Seongnam, South Korea
- Seongnam-si, South Korea
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anyang, South Korea; Bucheon-si, South Korea; Busan, South Korea; Changwon, South Korea; Cheonan, South Korea; Cheonju, South Korea and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.