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

NCT03908593 | Unknown Phase 4

• 1 other identifier: IISR-2016-101603 (RJ)
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastrointestinal Ulcer (Peptic) or Erosion; Anti-Platelet Therapy; Coronary Artery Bypass

Keywords

Gastrointestinal; Mucosal injury; Antiplatelet; Coronary artery bypass grafting; Prevention

Outcome Measures

Primary Outcomes (1)

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

  Gastroduodenal erosions and ulcers will be assessed according to the Lanza Endoscopic Scoring System. Lanza score is a categorical score (0-4) and defined as follows: 0, normal; 1, mucosal hemorrhages only; 2, 1-2 erosions; 3, 3-10 erosions; 4, \>10 erosions or an ulcer ≥3 mm. In addition, ≥1 ulcer with a diameter no less than 5mm will be grouped separately.

  within 12 months after randomization

Secondary Outcomes (4)

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

  6 months after randomization

• Cumulative rate of patients with upper gastrointestinal bleeding (UGIB) according to the modified TIMI criteria.

  within 12 months after randomization

• Percentage of patients with reflux esophagitis evaluated by EGD.

  12 months after randomization

• Percentage of patients with reflux esophagitis evaluated by EGD.

  6 months after randomization

Other Outcomes (3)

• Cumulative rate of patients with major adverse cardiovascular events (MACE).

  up to 12 months

• The failure rate of grafts assessed by computed tomographic angiography or coronary angiography.

  up to 12 months

• Cumulative rate of patients with all-cause death

  up to 12 months

Study Arms (2)

One month of therapy

ACTIVE COMPARATOR

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

Drug: Pantoprazole

Twelve months of 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 of therapy; Twelve months of therapy

Eligibility Criteria

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

You may not qualify if:

• 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.
• Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, 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.
• Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of investigator OR women who have a positive pregnancy test at enrollment or randomization OR women who are breasting-feeding.
• Inability of patient to understand and/or comply with study procedures and/or follow up, in the opinion of the investigator, OR any conditions that, in the opinion of the investigator, many render the patient unable to complete the study.
• Any condition outside the atherothrombotic study area with a life expectancy of less than 1 year.
• Participation in another clinical study with an investigational product within 28 days prior to enrolment or previous randomization to an investigational product in another ongoing clinical study.
• Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, long-term concomitant treatment with non-steroidal anti-inflammatory drugs \[NSAIDs\])

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

Related Publications (1)

• Zhu Y, Wang X, Yang Y, Liu L, Zhao Q, Yu L. Proton pump inhibitor in the prevention of upper gastrointestinal mucosal injury associated with dual antiplatelet therapy after coronary artery bypass grafting (DACAB-GI-2): study protocol for a randomized controlled trial. Trials. 2022 Jul 15;23(1):569. doi: 10.1186/s13063-022-06464-w.

  PMID: 35840999 DERIVED

MeSH Terms

Interventions

Pantoprazole

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

  Department of Gastroenterology, Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Qiang Zhao, MD, Ph.D

  Department of Cardiovascular Surgery, Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Yunpeng Zhu, MD

  Department of Cardiovascular Surgery, Ruijin Hospital

  STUDY DIRECTOR

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: April 5, 2019
• First Posted: April 9, 2019
• Study Start: October 14, 2019
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)