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Compares treatment options for Acute Coronary Syndrome
Official title The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
ClinicalTrials.gov ID: NCT04728516
What this study is testing
What is Vonoprazan-based dual eradication therapy for two weeks?
Vonoprazan-based dual eradication therapy for two weeks is an investigational medicine, given as an once-daily, being studied as a potential treatment for acute coronary syndrome.
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
- Patients with acute coronary syndrome (ACS) after Percutaneous Coronary Intervention (PCI) require routine treatment with dual antiplatelet (DAPT) treatment, but with the high risk of bleeding, gastrointestinal bleeding is the most common type of major bleeding. Helicobacter pylori (Hp) infection is a high-risk factor for gastrointestinal bleeding, with an incidence of about 50%.
- 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 18 and older
You may be able to join if
- Patients with ACS and PCI treatment and postoperative DAPT ≥ 6 months;
- Hp infection is positive;
- Age ≥18 years old;
- The patient himself or his authorized client signs the subject's consent.
You likely can't join if
- Previous history of gastrointestinal ulcer bleeding;
- Long-term use of PPI and H2 receptor inhibitors in the past;
- Complicated with gastroesophageal varices, or after gastrectomy;
- Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin) ,factor X or factor II inhibitors;
- Recently received fibrinolytic therapy (using fibrin-specific drugs within 24 hours before randomization, or using non-fibrin-specific drugs within...
- Recently accepted (within 30 days before randomization) or planned to undergo coronary artery bypass grafting (CABG);
See the full eligibility criteria
- Patients with ACS and PCI treatment and postoperative DAPT ≥ 6 months;
- Hp infection is positive;
- Age ≥18 years old;
- The patient himself or his authorized client signs the subject's consent.
- Previous history of gastrointestinal ulcer bleeding;
- Long-term use of PPI and H2 receptor inhibitors in the past;
- Complicated with gastroesophageal varices, or after gastrectomy;
- Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin) ,factor X or factor II inhibitors;
- Recently received fibrinolytic therapy (using fibrin-specific drugs within 24 hours before randomization, or using non-fibrin-specific drugs within 48 hours before randomization);
- Recently accepted (within 30 days before randomization) or planned to undergo coronary artery bypass grafting (CABG);
- Combining active bleeding or coagulation dysfunction (indicator);
- In patients with liver and kidney disease, serum creatinine is greater than 150 μmol/L, GFR \<60ml/min/1.73m2, alanine aminotransferase and aspartate aminotransferase increase ≥3 times from the normal value;
- Complicated with hemorrhagic stroke, intracranial tumor, arteriovenous malformation or aneurysm;
- Anemia (adult male hemoglobin less than 120 g/L or red blood cells less than 4×10\^12/L,adult female hemoglobin less than 105 g/L or red blood cells less than 3.5×10\^12/L);
- Systemic glucocorticoid application;
- Have taken antibiotics and other drugs that affect the flora in the stomach within the past month;
- A history of allergy to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin and other test drugs;
- Pregnancy or breastfeeding women and people of childbearing age who do not want to take contraceptive measures;
- With malignant tumors and other diseases, the expected survival time is less than 1 year;
- Patients who participated in clinical trials of other drugs or are participating in clinical studies of other new drugs within 30 days before enrollment;
- Complicated with mental illness or severe neurosis;
- Can't express subjective discomfort symptoms;
- The investigator decides that it is not suitable to participate in this research.
The study team makes the final eligibility decision.
Where it's taking place
- Bozhou, Anhui, China
- Chuzhou, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Zunyi, Guizhou, China
- Zhengzhou, Henan, China
- Dalian, Liaoning, China
- Xining, Qinghai, China
- Dezhou, Shandong, China
- Dongying, Shandong, China
- Heze, Shandong, China
- Jinan, Shandong, China
- Jining, Shandong, China
- Liaocheng, Shandong, China
- Linyi, Shandong, China
- Qingdao, Shandong, China
- Weifang, Shandong, China
- Weihai, Shandong, China
- Yantai, Shandong, China
- Zaozhuang, Shandong, China
+ 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bozhou, Anhui, China; Chuzhou, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Zunyi, Guizhou, China; Zhengzhou, Henan, China 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.