WithdrawnPhase 4

Proton Pump Inhibitor Prevent Dual Antiplatelet Agents Induced Gastrointestinal Ulcer After Coronary Artery Bypass Graft

Stopped: A new registration has been submitted due to a redesign of the study protocol.

China0Started 2018-10

Plain-language summary

The purpose of this study is to determine whether 12-month prophylactic treatment with pantoprazole is superior to 1-month therapy without major cardiovascular events (MACE) increased significantly, in prevention of dual antiplatelet therapy (DAPT)-induced upper gastrointestinal (GI) mucosal injury after coronary artery bypass graft (CABG) surgery. The potentially serious harm of DAPT on gastroduodenal mucosa will be assessed by esophagogastroduodenoscopy (EGD).

Who can participate

Age range30 Years – 80 Years

SexALL

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Exclusion criteria

✕. Provision of informed consent prior to any study specific procedures.
✕. CABG surgery is performed for the first time.
✕. Need 12-month DAPT (aspirin 100mg qd plus clopidogrel 75mg qd or aspirin 100mg qd plus ticagrelor 90mg bid depending on randomisation) immediately following CABG surgery according to the guideline.
✕. Concomitant use of pantoprazole (40mg qd) for at least 1 moth following CABG surgery.
✕. Willing to undergo EGD twice a year (at 6th and 12th month following CABG surgery, respectively).
✕. Willing to undergo 13C-UBT prior to CABG surgery.
✕. History of previous active peptic ulcer within 3 months prior to enrollment.
✕. Planned use of PPI to treat gastric-acid associated diseases (e.g. gastroesophageal reflux disease, GERD)

What they're measuring

Cumulative incidence of gastroduodenal erosions and ulcers.

Timeframe: up to 12 months

Trial details

NCT IDNCT03038009

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09

View on ClinicalTrials.gov More Gastric Ulcer Induced by Antiplatelet Agent trials