Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05820048
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-19
First Post:
2023-04-06
Brief Title:
The Efficacy and Safty of Proton Pump Inhibitor Lansoprazole
Sponsor:
Daejeon St Marys hospital
Organization:
Daejeon St Marys hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPI
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
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:
1 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
2 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
3 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
2 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
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None