UnknownPhase 4

Proton Pump Inhibitor Preventing Upper Gastrointestinal Injury In Patients On Dual Antiplatelet Therapy After CABG

China232 participantsStarted 2019-10-14

Plain-language summary

The purpose of this study is to compare the efficacy and safety for 12- vs. 1-month of pantoprazole treatment in preventing dual antiplatelet therapy (DAPT)-related upper gastrointestinal mucosal injury after coronary artery bypass grafting (CABG). To date, there has been no study using esophagogastroduodenoscopy (EGD) to compare the differences in upper gastrointestinal mucosal injury (including reflux esophagitis) after 6 and 12 months of PPI treatment combined with two different DAPT regimens (clopidogrel plus aspirin or ticagrelor plus aspirin).

Who can participate

Age range

18 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.

Exclusion criteria

. Provision of signed informed consent prior to any study specific procedures.
. Male or female, age ≥ 18 years at the time of consent.
. Planned or initiated use of 12 months of DAPT (aspirin plus clopidogrel or aspirin plus ticagrelor) immediately following primary isolated elective CABG surgery.
. History of previous active peptic ulcer within 3 months prior to enrollment.
. Planned use of PPIs to treat acid-associated disorders (e.g. gastroesophageal reflux disease, GERD)
. Contraindications for aspirin, clopidogrel, ticagrelor and pantoprazole use (e.g. known allergy)
. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices, that cannot be stopped for the course of the study.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Percentage of patients with gastroduodenal erosions and ulcers evaluated by EGD.

Timeframe: within 12 months after randomization

Trial details

NCT IDNCT03908593

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Gastrointestinal Ulcer (Peptic) or Erosion trials