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

NCT03038009 | Withdrawn Phase 4

• 1 other identifier: IISR-2016-101603
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastric Ulcer Induced by Antiplatelet Agent; Ulcer of the Gastrointestinal Tract; Proton Pump Inhibitor

Keywords

Coronary Artery Bypass Graft; Dual Antiplatelet Therapy; Gastrointestinal; Mucosal Injury; Proton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of gastroduodenal erosions and ulcers.

  up to 12 months

Secondary Outcomes (5)

• Incidence of gastroduodenal erosions and ulcers.

  up to 6 months

• Incidence of upper GI major bleeding according to TIMI criteria.

  up to 12 months

• Incidence of upper GI minor bleeding according to TIMI criteria

  up to 12 months

• Incidence of major cardiovascular events (MACE, composite of cardiovascular death, myocardial infarctions, or stroke).

  up to 12 months

• Incidence of grafts failure.

  up to 12 months

Study Arms (2)

One-month therapy

ACTIVE COMPARATOR

Pantoprazole, 40mg, tablet, oral, once daily for 1 month.

Drug: Pantoprazole

Twelve-month therapy

EXPERIMENTAL

Pantoprazole, 40mg, tablet, oral, once daily for 12 months.

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

Pantoprazole (40mg qd) will be concomitant used with DAPT

Also known as: PANTOLOC, Tablet from Takeda Pharmaceutical Company Limited

One-month therapy; Twelve-month therapy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)
• 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.
• Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir
• CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses \> 40mg daily or lovastatin at doses \> 40mg daily.
• Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin.
• History of previous intracerebral bleeding at any time, GI bleeding within the past 3 months prior to enrollment, or major surgery within 30 days prior to enrollment.
• Known moderate to severe liver disease (e.g. gastroesophageal varices, ascites and/ or clinical signs of coagulopathy)

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lifen Yu, MD, Ph.D

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Gastroenterology

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: January 31, 2017
• Study Start: October 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)