Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01037491
Status:
UNKNOWN
Last Update Posted:
2010-06-08
First Post:
2009-12-21
Brief Title:
Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Comparison of Ulcer Healing in Patients Taking Rabeprazole Plus Aspirin Versus Rabeprazole Plus Clopidogrel for Acute Peptic Ulcer
Status:
UNKNOWN
Status Verified Date:
2010-06
Last Known Status:
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:
Clopidogrel causes significantly less peptic ulcer disease PUD and ulcer bleeding than low-dose aspirin in general population However clopidogrel is not safe enough for gastrointestinal GI mucosa in patients who had past history of aspirin-associated ulcer or ulcer bleeding Aspirin plus proton pump inhibitor PPI is superior to clopidogrel alone in preventing recurrent ulcer bleeding in these high risk patients
This study is to compare the ulcer healing rate and ulcer bleeding at 12 weeks in patients with aspirin-associated PUD when they take PPI rabeprazole 20 mgday to treat their PUD and simultaneously take aspirin or clopidogrel for their cardiovascular CV prevention Two hundred patients will be randomly assigned rabeprazole 20 mgday plus aspirin 100 mgday or rabeprazole 20 mgday plus clopidogrel 75 mgday for 12 weeks The primary end point is treatment success ulcer healing rate The secondary end point is incidence of ulcer bleeding within 12 weeks
If rabeprazole plus aspirin in not inferior to rabeprazole plus clopidogrel in the incidence of ulcer healing and ulcer bleeding in the healing phasePPI plus aspirin rather than PPI plus clopidogrel will be recommended during acute ulcer healing in patients who need antiplatelet therapy for their CV prevention
This study is to compare the ulcer healing rate and ulcer bleeding at 12 weeks in patients with aspirin-associated PUD when they take PPI rabeprazole 20 mgday to treat their PUD and simultaneously take aspirin or clopidogrel for their cardiovascular CV prevention Two hundred patients will be randomly assigned rabeprazole 20 mgday plus aspirin 100 mgday or rabeprazole 20 mgday plus clopidogrel 75 mgday for 12 weeks The primary end point is treatment success ulcer healing rate The secondary end point is incidence of ulcer bleeding within 12 weeks
If rabeprazole plus aspirin in not inferior to rabeprazole plus clopidogrel in the incidence of ulcer healing and ulcer bleeding in the healing phasePPI plus aspirin rather than PPI plus clopidogrel will be recommended during acute ulcer healing in patients who need antiplatelet therapy for their CV prevention
Detailed Description:
None
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