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The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole) (PPI)

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lansoprazole 15 mg
Sponsored by
Daejeon St. Mary's hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring proton pump inhibitor, percutaneous coronary intervention, gastrointestinal bleeding of moderate risk, dual anti-platelet drugs

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 19 years of age or older Coronary artery disease has one or more of the following Stable angina unstable angina N on ST elevation myocardial infarction ST elevation myocardial infarction Those who are scheduled to receive or are taking dual antiplatelet therapy including aspirin after PCI trials A person whose risk of bleeding falls under an intermediate risk group. Exclusion Criteria: age < 19 years known allergy to aspirin and clopidogrel A person classified as a high-risk group according to the gastrointestinal risk assessment index liver cirrhosis known iron deficiency anemia recent fibrinolytic therapy active cancer end-stage renal failure life expectancy < 1 year co-prescription of NSAIDs, corticosteroid and anticoagulant such as NOAC or warfarin pregnancy mentally or cognitively disabled people mechanical ventilation with endotracheal intubation Persons who do not agree to participate in the study persons related unequally to investigators (students and employees)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    proton pump inhibitor

    non-administered army

    Arm Description

    medication : Lanston capacity : 15mg Number of times : QD period : 6 month Injection path : oral

    No Intervention

    Outcomes

    Primary Outcome Measures

    Occurrence of upper gastrointestinal clinical complex
    Upper gastrointestinal bleeding with clear origin,upper gastrointestinal bleeding with unclear origin, potential upper gastrointestinal bleeding or perforation

    Secondary Outcome Measures

    The occurrence of a cardiovascular clinical complex
    Combined variables of cardiovascular death, non-fatal myocardial infarction, coronary artery reopening, or ischemic stroke

    Full Information

    First Posted
    April 6, 2023
    Last Updated
    April 6, 2023
    Sponsor
    Daejeon St. Mary's hospital
    Collaborators
    Jeil Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05820048
    Brief Title
    The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)
    Acronym
    PPI
    Official Title
    The Efficacy and Safety of Proton Pump Inhibitor ( in Patients With Moderate Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary: A Randomised, Open ,Compared With Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    July 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Daejeon St. Mary's hospital
    Collaborators
    Jeil Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Among patients who performed percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD), enrollment is performed in patients with moderate risk in gastrointestinal risk assessment indicators. After obtaining the consent form, patients are randomly assigned to the gastric acid secretion inhibitor group and the non-dose group. Researchers and subjects proceed with the treatment group assignment, treatment-group assignment uses a random number table and the assigned drug is disclosed. Random checks are generated by statisticians and managed by the researchers. In the test group, the incidence of gastrointestinal clinical events in DAPT patients is expected to be low while taking PPI, but there is a burden of PPI costs. In the case of the control group, the burden of PPI costs is reduced, but there is a possibility that the incidence of clinical events may occur, although it is a small number. Subjects in the test group will take DAPT for at least 6 months from the time of registration, and NSAIDs drugs or steroids and NOAC or warfarin should be prohibited as combination taboo drugs when participating in the study. Data will be collected during normal medical procedures and will be checked through an endoscope in case of upper gastrointestinal bleeding
    Detailed Description
    Purpose : This study compares gastrointestinal and cardiovascular events with coronary artery disease (CAD) patients who underwent percutaneous coronary angioplasty in patients with moderate gastrointestinal bleeding risk with use of dual antiplatelet drugs (DAPT), especially controversial use of prophylactic acid secretion inhibitors, and attempts to confirm the effectiveness and safety of gastric acid secretion inhibitors Background : DPAT is a standard treatment in patients with CAD with percutaneous coronary intervention (PCI). However, it is important to consider the GI bleeding risk when using DAPT and to determine whether Proton Pump Inhibitor (PPI) should be prescribed to prevent such accidents. DAPT, or aspirin and P2Y12 receptor inhibitor, complementarily reduce platelet activation and aggregation and consequently reduce the progression of coronary thrombosis. We have reported whether PPI use is associated with ischemic events or mortality in patients with DAPT up to date, but we have shown conflicting results depending on the type of study conducted. Observational studies generally show that PPI increases all-cause and cardiovascular mortality, angina and stroke, while RCT studies show that it does not. This difference can be explained by the selection bias. This is because observational studies attempt to reduce selective bias through correction of basic patient characteristics, but unmeasured differences in underlying variables continue to affect the results. method : Among patients who performed PCI in patients with CAD, enrollment is performed in patients with moderate risk in gastrointestinal risk assessment indicators. After obtaining the consent form, patients are randomly assigned to the gastric acid secretion inhibitor group and the non-dose group. Researchers and subjects proceed with the treatment group assignment, treatment-group assignment uses a random number table and the assigned drug is disclosed. Random checks are generated by statisticians and managed by the researchers. In the test group, the incidence of gastrointestinal clinical events in DAPT patients is expected to be low while taking PPI, but there is a burden of PPI costs. In the case of the control group, the burden of PPI costs is reduced, but there is a possibility that the incidence of clinical events may occur, although it is a small number. Subjects in the test group will take DAPT for at least 6 months from the time of registration, and NSAIDs drugs or steroids and NOAC or warfarin should be prohibited as combination taboo drugs when participating in the study. Data will be collected during normal medical procedures and will be checked through an endoscope in case of upper gastrointestinal bleeding

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease
    Keywords
    proton pump inhibitor, percutaneous coronary intervention, gastrointestinal bleeding of moderate risk, dual anti-platelet drugs

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    proton pump inhibitor
    Arm Type
    Active Comparator
    Arm Description
    medication : Lanston capacity : 15mg Number of times : QD period : 6 month Injection path : oral
    Arm Title
    non-administered army
    Arm Type
    No Intervention
    Arm Description
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Lansoprazole 15 mg
    Other Intervention Name(s)
    non-administered army
    Intervention Description
    Short-term treatment of active duodenal ulcer Short-term treatment of active benign gastric ulcers Thin heat of Helicobacter pylori to prevent recurrence of duodenal ulcer Maintain duodenal ulcer after treatmentLaw Treatment of nonsteroidal anti-inflammatory analgesics-induced gastric ulcers Reducing the risk of developing nonsteroidal anti-inflammatory analgesic-induced gastric ulcers Short-term treatment of gastroesophageal reflux disease Short-term treatment of erosive reflux esophagitis Post-treatment maintenance therapy for erosive reflux esophagitis Pathological hyperdivision, including Zolinger Ellison syndrome
    Primary Outcome Measure Information:
    Title
    Occurrence of upper gastrointestinal clinical complex
    Description
    Upper gastrointestinal bleeding with clear origin,upper gastrointestinal bleeding with unclear origin, potential upper gastrointestinal bleeding or perforation
    Time Frame
    6 month after randomization
    Secondary Outcome Measure Information:
    Title
    The occurrence of a cardiovascular clinical complex
    Description
    Combined variables of cardiovascular death, non-fatal myocardial infarction, coronary artery reopening, or ischemic stroke
    Time Frame
    6 month after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 19 years of age or older Coronary artery disease has one or more of the following Stable angina unstable angina N on ST elevation myocardial infarction ST elevation myocardial infarction Those who are scheduled to receive or are taking dual antiplatelet therapy including aspirin after PCI trials A person whose risk of bleeding falls under an intermediate risk group. Exclusion Criteria: age < 19 years known allergy to aspirin and clopidogrel A person classified as a high-risk group according to the gastrointestinal risk assessment index liver cirrhosis known iron deficiency anemia recent fibrinolytic therapy active cancer end-stage renal failure life expectancy < 1 year co-prescription of NSAIDs, corticosteroid and anticoagulant such as NOAC or warfarin pregnancy mentally or cognitively disabled people mechanical ventilation with endotracheal intubation Persons who do not agree to participate in the study persons related unequally to investigators (students and employees)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    DaeWon Kim, MD PhD
    Phone
    820422209686
    Email
    mirinesilver@catholic.ac.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    HaNa Lee
    Phone
    820422209943
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    DaeWon Kim
    Organizational Affiliation
    Cardiovascular Center, Mary's Hospital,64, Daeheung-ro, Jung-gu, Daejeon, Republic of Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30522654
    Citation
    Capodanno D, Alfonso F, Levine GN, Valgimigli M, Angiolillo DJ. ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline Comparison. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2915-2931. doi: 10.1016/j.jacc.2018.09.057.
    Results Reference
    result
    PubMed Identifier
    25286881
    Citation
    Franchi F, Angiolillo DJ. Novel antiplatelet agents in acute coronary syndrome. Nat Rev Cardiol. 2015 Jan;12(1):30-47. doi: 10.1038/nrcardio.2014.156. Epub 2014 Oct 7.
    Results Reference
    result
    PubMed Identifier
    21126648
    Citation
    Abraham NS, Hlatky MA, Antman EM, Bhatt DL, Bjorkman DJ, Clark CB, Furberg CD, Johnson DA, Kahi CJ, Laine L, Mahaffey KW, Quigley EM, Scheiman J, Sperling LS, Tomaselli GF; ACCF/ACG/AHA. ACCF/ACG/AHA 2010 expert consensus document on the concomitant use of proton pump inhibitors and thienopyridines: a focused update of the ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use. A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. J Am Coll Cardiol. 2010 Dec 7;56(24):2051-66. doi: 10.1016/j.jacc.2010.09.010. No abstract available.
    Results Reference
    result
    PubMed Identifier
    15758000
    Citation
    Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005 Mar 24;352(12):1179-89. doi: 10.1056/NEJMoa050522. Epub 2005 Mar 9.
    Results Reference
    result
    PubMed Identifier
    11519503
    Citation
    Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746. Erratum In: N Engl J Med 2001 Dec 6;345(23):1716. N Engl J Med 2001 Nov 15;345(20):1506.
    Results Reference
    result
    PubMed Identifier
    22249527
    Citation
    Moukarbel GV, Bhatt DL. Antiplatelet therapy and proton pump inhibition: clinician update. Circulation. 2012 Jan 17;125(2):375-80. doi: 10.1161/CIRCULATIONAHA.111.019745. No abstract available.
    Results Reference
    result
    PubMed Identifier
    22688850
    Citation
    Laine L, Yang H, Chang SC, Datto C. Trends for incidence of hospitalization and death due to GI complications in the United States from 2001 to 2009. Am J Gastroenterol. 2012 Aug;107(8):1190-5; quiz 1196. doi: 10.1038/ajg.2012.168. Epub 2012 Jun 12.
    Results Reference
    result
    PubMed Identifier
    20925534
    Citation
    Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP; COGENT Investigators. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17. doi: 10.1056/NEJMoa1007964. Epub 2010 Oct 6.
    Results Reference
    result
    PubMed Identifier
    30851041
    Citation
    Sehested TSG, Carlson N, Hansen PW, Gerds TA, Charlot MG, Torp-Pedersen C, Kober L, Gislason GH, Hlatky MA, Fosbol EL. Reduced risk of gastrointestinal bleeding associated with proton pump inhibitor therapy in patients treated with dual antiplatelet therapy after myocardial infarction. Eur Heart J. 2019 Jun 21;40(24):1963-1970. doi: 10.1093/eurheartj/ehz104.
    Results Reference
    result
    PubMed Identifier
    26751904
    Citation
    Schoenfeld AJ, Grady D. Adverse Effects Associated With Proton Pump Inhibitors. JAMA Intern Med. 2016 Feb;176(2):172-4. doi: 10.1001/jamainternmed.2015.7927. No abstract available.
    Results Reference
    result
    PubMed Identifier
    31152740
    Citation
    Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology. 2019 Sep;157(3):682-691.e2. doi: 10.1053/j.gastro.2019.05.056. Epub 2019 May 29.
    Results Reference
    result
    PubMed Identifier
    28886622
    Citation
    Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
    Results Reference
    result
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/30522654/
    Description
    ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline Comparison
    URL
    https://pubmed.ncbi.nlm.nih.gov/25286881/
    Description
    Novel antiplatelet agents in acute coronary syndrome
    URL
    https://pubmed.ncbi.nlm.nih.gov/21126648/
    Description
    ACCF/ACG/AHA 2010 expert consensus document on the concomitant use of proton pump inhibitors and thienopyridines: a focused update of the ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID
    URL
    http://pubmed.ncbi.nlm.nih.gov/15758000/
    Description
    Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation
    URL
    http://pubmed.ncbi.nlm.nih.gov/11519503/
    Description
    Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation
    URL
    https://pubmed.ncbi.nlm.nih.gov/22249527/
    Description
    Antiplatelet therapy and proton pump inhibition: clinician update
    URL
    https://pubmed.ncbi.nlm.nih.gov/22688850/
    Description
    Trends for incidence of hospitalization and death due to GI complications in the United States from 2001 to 2009
    URL
    https://pubmed.ncbi.nlm.nih.gov/20925534/
    Description
    Clopidogrel with or without omeprazole in coronary artery disease
    URL
    https://pubmed.ncbi.nlm.nih.gov/30851041/
    Description
    Reduced risk of gastrointestinal bleeding associated with proton pump inhibitor therapy in patients treated with dual antiplatelet therapy after myocardial infarction
    URL
    https://pubmed.ncbi.nlm.nih.gov/26751904/
    Description
    Adverse Effects Associated With Proton Pump Inhibitors
    URL
    https://pubmed.ncbi.nlm.nih.gov/31152740/
    Description
    Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin
    URL
    https://pubmed.ncbi.nlm.nih.gov/28886622/
    Description
    2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European

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    The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)

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