Ignite Creation Date:
2024-05-06 @ 1:08 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01735227
Status:
UNKNOWN
Last Update Posted:
2012-11-28
First Post:
2012-11-14
Brief Title:
Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical TrialsOPEN
Sponsor:
Yaling Han
Organization:
Shenyang Northern Hospital
Study Overview
Official Title:
Single-center Randomized Controlled Study of Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Randomized Controlled Trials
Status:
UNKNOWN
Status Verified Date:
2012-11
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect the investigators designed a clinical randomized controlled trials of omeprazole and pantoprazole antiplatelet effect of clopidogrel In this experiment the investigators have taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly divided into omeprazole and pantoprazole groups On the day of admission all patients taking clopidogrel loading dose 300mg aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg aspirin 300mg and omeprazole group taking omeprazole 20mg d pantoprazole group taking pantoprazole 20mg d Respectively on the day of admission before medication medication for 12-24 hours medication after 72 hours 30 days each taken early morning fasting venous blood again measuring AA ADP - induced platelet aggregation And selected 30 days 6 months and 12 months to record the patients clinical adverse events including death myocardial infarction and any revascularization stent thrombosis recurrent angina rehospitalization due to cardiovascular disease bleeding events To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year follow-up results and further explore the optimal combination of dual anti-platelet and joint PPIs course of treatment appropriate dosage and the best time to provide reasonable for clinical programs to create a personalized treatment system improve the patients quality of life
Detailed Description:
Through a number of large-scale clinical trials Meta analysis and clinical treatment guidelines confirm that clopidogrel and aspirin dual antiplatelet treatment strategies for acute coronary syndrome ACS undergoing percutaneous coronary interventionsPCI of stent implantation surgery patients have a vital role It can effectively suppress acute subacute stent thrombosis formation reduce readmissions ratio thus greatly improving the quality of life of patients A large number of clinical practice reports although the treatment strategies to reduce the incidence of adverse cardiovascular events it has increased the possibility of the occurrence of gastrointestinal bleeding complications Proton pump inhibitors PPIs are often used to prevent gastrointestinal complications of dual antiplatelet therapy 2008 American College of Cardiology ACC American Society of Gastroenterology ACG American Heart Association AHA jointly issued a consensus document consistently recommended that the majority of clinicians application of dual antiplatelet and PPIs treatment for patients with risk factors for gastrointestinal bleeding that may exist at the same time in order to reduce the occurrence of gastrointestinal adverse events But at home and abroad in recent years there have been reports suggest that the interaction of PPIs with clopidogrel may exist thereby reduce the latter s anti- platelet effect in order to make the incidence of adverse CV events increased about 25-64 In January 2009 the US Food and Drug Administration FDA announced a safety review of an earlier report on the potential interaction of these two types drugs particularly stressed the need to carry out a large number of clinical practice research further to clear both the interaction PPIs antiplatelet effects of clopidogrel after PCI is not yet very clear clinical results on both interactions still exist many different academic perspectives and research defects so still need to arouse sufficient attention continue to carry out the relevant fields research
In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect the investigators designed a clinical randomized controlled trials of omeprazole and pantoprazole antiplatelet effect of clopidogrel In this experiment the investigator have taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly divided into omeprazole and pantoprazole groups On the day of admission all patients taking clopidogrel loading dose 300mg aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg aspirin 300mg and omeprazole group taking omeprazole 20mg d pantoprazole group taking pantoprazole 20mg d Respectively on the day of admission before medication medication for 12-24 hours medication after 72 hours 30 days each taken early morning fasting venous blood again measuring AA ADP - induced platelet aggregation And selected 30 days 6 months and 12 months to record the patients clinical adverse events including death myocardial infarction and any revascularization stent thrombosis recurrent angina rehospitalization due to cardiovascular disease bleeding events To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year follow-up results and further explore the optimal combination of dual anti-platelet and joint PPIs course of treatment appropriate dosage and the best time to provide reasonable for clinical programs to create a personalized treatment system improve the patients quality of life
In order to further clarify the interaction of PPIs with clopidogrel anti - platelet effect the investigators designed a clinical randomized controlled trials of omeprazole and pantoprazole antiplatelet effect of clopidogrel In this experiment the investigator have taken a randomized NSTE-ACS hospitalized patients met the inclusion criteria were randomly divided into omeprazole and pantoprazole groups On the day of admission all patients taking clopidogrel loading dose 300mg aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg aspirin 300mg and omeprazole group taking omeprazole 20mg d pantoprazole group taking pantoprazole 20mg d Respectively on the day of admission before medication medication for 12-24 hours medication after 72 hours 30 days each taken early morning fasting venous blood again measuring AA ADP - induced platelet aggregation And selected 30 days 6 months and 12 months to record the patients clinical adverse events including death myocardial infarction and any revascularization stent thrombosis recurrent angina rehospitalization due to cardiovascular disease bleeding events To assess the impact of PPIs on clopidogrel antiplatelet effect by observing 1 year follow-up results and further explore the optimal combination of dual anti-platelet and joint PPIs course of treatment appropriate dosage and the best time to provide reasonable for clinical programs to create a personalized treatment system improve the patients quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None