Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04416581
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-05-28
Brief Title:
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Sponsor:
Duk-Woo Park MD
Organization:
Asan Medical Center
Study Overview
Official Title:
A Multi-centre Randomized Double-Blind Double-Dummy Parallel-Group Phase 4 Efficacy and Safety Study of P-CAB Tegoprazan 50 mg Once Daily Compared With PPI Rabeprazole 20 mg Once Daily to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease
Status:
RECRUITING
Status Verified Date:
2024-07
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:
PROTECT-HBR
Brief Summary:
The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB tegoprazan 50 mg once daily as compared with standard PPI rabeprazole 20 mg once daily for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs either antiplatelets OAC and its combinations who are at high GI bleeding risk The primary hypothesis is that P-CAB experimental arm would non-inferior to PPI standard arm with respect to the rate of the primary composite end point of GI events at 12 months after randomization
Detailed Description:
Before randomization phase one lead-in subject N 300 patients will be enrolled to perform safety surveillance of standard-dose tegoprazan 50 mg for 6 months and to ensure the safety of tegoprazan safety surveillance phase Data on lead-in subjects will not be included in the data set used for primary analyses
The safety of tegoprazan will be estimated SIAEsSpecial Interest Adverse Events as follows Composite Event
1 liver function abnormalities
2 hypergastrinemia or
3 enteric infection
Definitions
liver function abnormality defined as AST or ALT3 upper limit of normal or two consecutive measurements of total bilirubin 2 x upper limit of normal
hypergastrinemia
enteric infection including Cdifficile infection
If there are any new tegoprazan-related findings it will be considered in the estimation
If there is no safety concern during safety surveillance phase investigator-driven randomized double-blind double-dummy active-controlled clinical trial N 3100 patients will be subsequently performed randomization phase
The safety of tegoprazan will be estimated SIAEsSpecial Interest Adverse Events as follows Composite Event
1 liver function abnormalities
2 hypergastrinemia or
3 enteric infection
Definitions
liver function abnormality defined as AST or ALT3 upper limit of normal or two consecutive measurements of total bilirubin 2 x upper limit of normal
hypergastrinemia
enteric infection including Cdifficile infection
If there are any new tegoprazan-related findings it will be considered in the estimation
If there is no safety concern during safety surveillance phase investigator-driven randomized double-blind double-dummy active-controlled clinical trial N 3100 patients will be subsequently performed randomization phase
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