Coronary Artery DiseasePhase 4PPINCT05820048
The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)
A Phase 4 study testing Lansoprazole 15 mg in people with Coronary Artery Disease, run by Daejeon St. Mary's hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Lansoprazole 15 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
No sites are listed yet.
HaNa Lee contact
About this study
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
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
Read the 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
- Conditions
- Coronary Artery Disease
- Being tested
- Lansoprazole 15 mg
- Keywords
- proton pump inhibitor, percutaneous coronary intervention, gastrointestinal bleeding of moderate risk, dual anti-platelet drugs
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole 15 mgDrug
Also called non-administered army
- 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
| Study group | Role | What they receive |
|---|---|---|
| proton pump inhibitor | Active comparator | 1. medication : Lanston
2. capacity : 15mg
3. Number of times : QD
4. period : 6 month
5. Injection path : oral Receives: Drug: Lansoprazole 15 mg |
| non-administered army | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of upper gastrointestinal clinical complex
Upper gastrointestinal bleeding with clear origin,upper gastrointestinal bleeding with unclear origin, potential upper gastrointestinal bleeding or perforation
Measured: 6 month after randomization
Secondary outcomes (1)
The occurrence of a cardiovascular clinical complex
Combined variables of cardiovascular death, non-fatal myocardial infarction, coronary artery reopening, or ischemic stroke
Measured: 6 month after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daejeon St. Mary's hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Kim Dae-Won, Daejeon St. Mary's hospital
- Investigators
- DaeWon Kim, Principal investigator, Cardiovascular Center, Mary's Hospital,64, Daeheung-ro, Jung-gu, Daejeon, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820048
- Sponsor's protocol ID
- DWKim
- Acronym
- PPI
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30522654Franchi 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.
PubMed 25286881Abraham 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.
PubMed 21126648Sabatine 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.
PubMed 15758000Yusuf 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.
PubMed 11519503Moukarbel 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.
PubMed 22249527Laine 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.
PubMed 22688850Bhatt 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.
PubMed 20925534Sehested 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.
PubMed 30851041Schoenfeld 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.
PubMed 26751904Moayyedi 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.
PubMed 31152740Valgimigli 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.
PubMed 28886622
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05820048
- Acronym / sponsor ID
- PPI / DWKim
- Conditions
- Coronary Artery Disease
- Keywords
- proton pump inhibitor, percutaneous coronary intervention, gastrointestinal bleeding of moderate risk, dual anti-platelet drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Daejeon St. Mary's hospitalUniversity, hospital or other
- Collaborators
- Jeil Pharmaceutical Co., Ltd.
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proton pump inhibitor | Active comparator | Drug: Lansoprazole 15 mg1. medication : Lanston 2. capacity : 15mg 3. Number of times : QD 4. period : 6 month 5. Injection path : oral |
| non-administered army | No intervention | –No Intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lansoprazole 15 mgAlso: non-administered army1. 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 | Drug | proton pump inhibitor |
Primary outcome
Occurrence of upper gastrointestinal clinical complex
Time frame: 6 month after randomization
Upper gastrointestinal bleeding with clear origin,upper gastrointestinal bleeding with unclear origin, potential upper gastrointestinal bleeding or perforation
1 secondary outcome
The occurrence of a cardiovascular clinical complex
Time frame: 6 month after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Results publication: PubMed 30522654Capodanno 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 publication: PubMed 25286881Franchi 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 publication: PubMed 21126648Abraham 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 publication: PubMed 15758000Sabatine 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 publication: PubMed 11519503Yusuf 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.
- Results publication: PubMed 22249527Moukarbel 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 publication: PubMed 22688850Laine 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 publication: PubMed 20925534Bhatt 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 publication: PubMed 30851041Sehested 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 publication: PubMed 26751904Schoenfeld 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 publication: PubMed 31152740Moayyedi 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 publication: PubMed 28886622Valgimigli 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.
- ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline ComparisonLink provided by the sponsor.
- Novel antiplatelet agents in acute coronary syndromeLink provided by the sponsor.
- 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 NSAIDLink provided by the sponsor.
- Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevationLink provided by the sponsor.
- Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevationLink provided by the sponsor.
- Antiplatelet therapy and proton pump inhibition: clinician updateLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HaNa Lee contact
DaeWon Kim principal investigator
Cardiovascular Center, Mary's Hospital,64, Daeheung-ro, Jung-gu, Daejeon, Republic of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole 15 mg in people with Coronary Artery Disease, run by Daejeon St. Mary's hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DaeWon Kim, MD PhD (820422209686, mirinesilver@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of upper gastrointestinal clinical complex (time frame: 6 month after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820048, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.