BridgeMD
Prevention study for Acute Coronary Syndromes (ACS)
Official title Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
ClinicalTrials.gov ID: NCT07479056
What this study is testing
What is Fexuprazan 40mg?
Fexuprazan 40mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute coronary syndromes (acs).
Also referred to as Fexuprazan, Fexuclue.
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
- This study evaluates whether fexuprazan is effective in preventing upper gastrointestinal bleeding and related upper gastrointestinal clinical events in high bleeding risk patients who require dual antiplatelet therapy after coronary stent implantation. A total of 400 participants at a single center will be randomly assigned in a 1:1 ratio within 48 hours after stent implantation to receive either fexuprazan 40 milligrams or lansoprazole 30 milligrams once daily for 6 months.
- 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 20 and older
You may be able to join if
- All four conditions below must be met.
- Patients who are 20 years of age or older, have undergone coronary artery stent implantation for coronary artery disease, and require dual...
- Patients are considered to be at high bleeding risk if at least 1 criteria are met (Based on clinical recommendations (6,7,10,14-16) and expert...
- A voluntary participant in this clinical trial who has provided written consent, or a legal guardian who has provided written consent on behalf of...
- Those who agree to use a medically valid method of contraception\ (including conditions in which pregnancy is medically impossible) during the...
You likely can't join if
- Patients who have a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drugs or have a history of...
- Patients with contraindications to antiplatelet agents, such as allergies.
- Genetic blood coagulation disorders
- Cases in which the investigator determines that the use of dual antiplatelet therapy is difficult due to severe liver cirrhosis, thrombocytopenia, or...
- Hemodynamically unstable at the time of randomization (cardiogenic shock, uncontrolled arrhythmia, severe heart failure: NYHA Class IV).
- Patients with warning symptoms suspected of digestive malignancy (unintentional significant weight loss, recurrent vomiting, dysphagia, hematemesis...
See the full eligibility criteria
- All four conditions below must be met.
- Patients who are 20 years of age or older, have undergone coronary artery stent implantation for coronary artery disease, and require dual antiplatelet therapy for 6 months or longer.
- Patients are considered to be at high bleeding risk if at least 1 criteria are met (Based on clinical recommendations (6,7,10,14-16) and expert consensus documents (17-19)) 1) Age ≥65 y 2) Low body weight (\<55 Kg for...
- A voluntary participant in this clinical trial who has provided written consent, or a legal guardian who has provided written consent on behalf of the participant.
- Those who agree to use a medically valid method of contraception\ (including conditions in which pregnancy is medically impossible) during the clinical trial period Women who are medically unable to become pregnant can...
- Medically valid contraceptive methods: intrauterine device (Loop, Mirena), physical barrier method (male condom, female condom (femidom)), subcutaneous contraception (Implanon, etc.), long-acting contraceptive...
- Patients who have a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drugs or have a history of clinically significant hypersensitivity reaction
- Patients with contraindications to antiplatelet agents, such as allergies.
- Genetic blood coagulation disorders
- Cases in which the investigator determines that the use of dual antiplatelet therapy is difficult due to severe liver cirrhosis, thrombocytopenia, or other medical conditions.
- Hemodynamically unstable at the time of randomization (cardiogenic shock, uncontrolled arrhythmia, severe heart failure: NYHA Class IV).
- Patients with warning symptoms suspected of digestive malignancy (unintentional significant weight loss, recurrent vomiting, dysphagia, hematemesis, melena, etc.) within the past 3 months
- Patients with malignancy or serious illnesses with an expected survival of less than 1 year.
- Severe anemia (hemoglobin \< 8 g/dL) or blood transfusion within 4 weeks of randomization.
- Active liver disease or impaired liver function (AST or ALT greater than three times the upper limit of normal).
- Advanced renal dysfunction: eGFR less than 30 mLmin/1.73m2 or patients receiving dialysis
- Patients taking drugs contraindicated for this clinical trial drug (e.g., patients taking atazanavir, nelfinavir, or rilpivirine-containing preparations)
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Concurrently taking CYP 3A4 and p-glycoprotein (P-GP) inhibitors.
- Dementia or individuals unable to understand the trial procedures or comply with the trial requirements
- Pregnant or breastfeeding women, or women planning to become pregnant
- Individuals with active infections, significant hematologic, renal, metabolic, gastrointestinal, endocrine disorders, or any other reason the investigator deems the subject unsuitable for participation in the clinical...
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Eunpyeong-gu, South Korea
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, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Eunpyeong-gu, South Korea. 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.