The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)

NCT05820048 | Unknown Phase 4

• 1 other identifier: DWKim
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Conditions

Coronary Artery Disease

Keywords

proton pump inhibitor; percutaneous coronary intervention; gastrointestinal bleeding of moderate risk; dual anti-platelet drugs

Outcome Measures

Primary Outcomes (1)

• Occurrence of upper gastrointestinal clinical complex

  Upper gastrointestinal bleeding with clear origin,upper gastrointestinal bleeding with unclear origin, potential upper gastrointestinal bleeding or perforation

  6 month after randomization

Secondary Outcomes (1)

• The occurrence of a cardiovascular clinical complex

  6 month after randomization

Study Arms (2)

proton pump inhibitor

ACTIVE COMPARATOR

1. medication : Lanston 2. capacity : 15mg 3. Number of times : QD 4. period : 6 month 5. Injection path : oral

Drug: Lansoprazole 15 mg

non-administered army

NO INTERVENTION

No Intervention

Interventions

Lansoprazole 15 mg DRUG

1. Short-term treatment of active duodenal ulcer 2. Short-term treatment of active benign gastric ulcers 3. Thin heat of Helicobacter pylori to prevent recurrence of duodenal ulcer 4. Maintain duodenal ulcer after treatmentLaw 5. Treatment of nonsteroidal anti-inflammatory analgesics-induced gastric ulcers 6. Reducing the risk of developing nonsteroidal anti-inflammatory analgesic-induced gastric ulcers 7. Short-term treatment of gastroesophageal reflux disease 8. Short-term treatment of erosive reflux esophagitis 9. Post-treatment maintenance therapy for erosive reflux esophagitis 10. Pathological hyperdivision, including Zolinger Ellison syndrome

Also known as: non-administered army

proton pump inhibitor

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Daejeon St. Mary's hospital: lead
• Jeil Pharmaceutical Co., Ltd.: collaborator

Related Publications (12)

• 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.

  PMID: 30522654 RESULT

• 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.

  PMID: 25286881 RESULT

• 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.

  PMID: 21126648 RESULT

• 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.

  PMID: 15758000 RESULT

• 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.

  PMID: 11519503 RESULT

• 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.

  PMID: 22249527 RESULT

• 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.

  PMID: 22688850 RESULT

• 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.

  PMID: 20925534 RESULT

• 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.

  PMID: 30851041 RESULT

• 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.

  PMID: 26751904 RESULT

• 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.

  PMID: 31152740 RESULT

• 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.

  PMID: 28886622 RESULT

Related Links

• ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline Comparison
• Novel antiplatelet agents in acute coronary syndrome
• 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
• Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation
• Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation
• Antiplatelet therapy and proton pump inhibition: clinician update
• Trends for incidence of hospitalization and death due to GI complications in the United States from 2001 to 2009
• Clopidogrel with or without omeprazole in coronary artery disease
• Reduced risk of gastrointestinal bleeding associated with proton pump inhibitor therapy in patients treated with dual antiplatelet therapy after myocardial infarction
• Adverse Effects Associated With Proton Pump Inhibitors
• Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin
• 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

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular 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

• DaeWon Kim

  Cardiovascular Center, Mary's Hospital,64, Daeheung-ro, Jung-gu, Daejeon, Republic of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DaeWon Kim, MD PhD

CONTACT

820422209686; mirinesilver@catholic.ac.kr

HaNa Lee

CONTACT

820422209943

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: May 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 31, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share