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Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy

ConditionsAcute Coronary Syndromes (ACS)Coronary Artery Disease (CAD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorSUK MIN SEO

About this trial

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. The study will compare upper gastrointestinal clinical events during follow-up

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 men, <50 Kg for women) 3)Hemoglobin <11g/dL 4) Platelet count <100×109/L 5) Severe CKD: eGFR <30mL/min/1.73m2,5 or on hemodialysis 6) Anticipated use of long-term oral anticoagulation (warfarin or direct-acting oral anticoagulants) 7) Long-term use of oral NSAIDs or steroids 8) Heart failure 9) A history of previous gastric or duodenal ulcer. 10) A history of previous gastrointestinal bleeding. 11)Previous or confirmed Helicobacter pylori infection

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fexuprazan 40mg

    Drug

    Fexuprazan 40 mg orally once daily + Lansoprazole placebo Matching placebo orally once daily.

  • Lansoprazole 30mg

    Drug

    Lansoprazole 30 mg orally once daily. + Fexuprazan placebo Matching placebo orally once daily.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Fexuprazan group(P-CAB)Experimental treatment 1 intervention
Group B: Lansoprazole group(PPI)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from randomization to first occurrence of a composite endpoint of upper gastrointestinal clinical events during the treatment period

This composite outcome includes: 1. Confirmed upper gastrointestinal bleeding (confirmed by upper endoscopy or computed tomography); 2. Presumed upper gastrointestinal bleeding with a documented decrease in hemoglobin of ≥ 2 g/dL or decrease in hematocrit of ≥ 10% from baseline; 3. Symptomatic gastroduodenal ulcer confirmed by endoscopy or computed tomography without evidence of bleeding; 4. Persistent abdominal pain or dyspeptic symptoms with multiple erosive lesions confirmed by endoscopy 5. Gastroduodenal perforation or obstruction.

Time frame
6 months after randomization

Secondary outcomes

1

Time from randomization to first occurrence of gastroesophageal reflux disease, as evidenced by symptomatic endoscopically-confirmed erosive esophagitis.

Time frame
6 months after randomization
2

Time from randomization of first occurrence of low gastrointestinal bleeding (conformed by the endoscopy or CT scan)

Time frame
6 months after randomization
3

Time from randomization to first occurrence of any GI bleeding

Time frame
6 months after randomization
4

BARC bleeding (BARC type 0, 1, 2, 3, 5)

Time frame
6 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SUK MIN SEO

Lead sponsor

Eunpyeong St. Mary's Hospital

Sponsor institution

Daewoong Pharmaceutical Co. LTD.

Collaborator

Source ClinicalTrials.gov
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