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| Name | Class |
|---|---|
| Jeil Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| proton pump inhibitor | Active Comparator |
|
|
| non-administered army | No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole 15 mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of a cardiovascular clinical complex | Combined variables of cardiovascular death, non-fatal myocardial infarction, coronary artery reopening, or ischemic stroke | 6 month after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DaeWon Kim, MD PhD | Contact | 820422209686 | mirinesilver@catholic.ac.kr | |
| HaNa Lee | Contact | 820422209943 |
| Name | Affiliation | Role |
|---|---|---|
| DaeWon Kim | Cardiovascular Center, Mary's Hospital,64, Daeheung-ro, Jung-gu, Daejeon, Republic of Korea | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30522654 | Result | 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. | |
| 25286881 | 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. |
| Label | URL |
|---|---|
| ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline Comparison | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Not provided
|
|
| 21126648 | 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. |
| 15758000 | 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. |
| 11519503 | 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. |
| 22249527 | 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. |
| 22688850 | 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. |
| 20925534 | 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. |
| 30851041 | 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. |
| 26751904 | 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. |
| 31152740 | 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. |
| 28886622 | 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. |
| Novel antiplatelet agents in acute coronary syndrome | View source |
| 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 | View source |
| Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation | View source |
| Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation | View source |
| Antiplatelet therapy and proton pump inhibition: clinician update | View source |
| Trends for incidence of hospitalization and death due to GI complications in the United States from 2001 to 2009 | View source |
| Clopidogrel with or without omeprazole in coronary artery disease | View source |
| Reduced risk of gastrointestinal bleeding associated with proton pump inhibitor therapy in patients treated with dual antiplatelet therapy after myocardial infarction | View source |
| Adverse Effects Associated With Proton Pump Inhibitors | View source |
| Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin | View source |
| 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 | View source |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |