Ignite Creation Date:
2024-05-05 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00715455
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2008-02-14
Brief Title:
Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI
Sponsor:
Regado Biosciences Inc
Organization:
Regado Biosciences Inc
Study Overview
Official Title:
Phase 2a Multi-Center Open Label Randomized FeasibilitySafety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Subjects Undergoing Elective PCI After Pretreatment With Clopidogrel and Aspirin
Status:
COMPLETED
Status Verified Date:
2013-05
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:
REVERSAL-PCI
Brief Summary:
The purpose of this study is to determine if it is feasible and safe to use the REG1 Anticoagulation System instead of unfractionated heparin during percutaneous coronary intervention PCI in subjects with coronary artery disease CAD
Detailed Description:
The study drug REG1 is the first specific direct-acting antidote-controlled anticoagulant ever described Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures These procedures which include coronary artery bypass grafting CABG and percutaneous coronary intervention PCI put patients at high risk for therapy-related bleeding complications REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures
REG1 is a two-component system consisting of an aptamer-based anticoagulant and its matched antidote The REG1 anticoagulant component RB006 is a single-stranded nucleic acid aptamer RB006 selectively and potently binds to and inhibits Factor IXa a protein critical to blood coagulation The antidote component RB007 is a complementary nucleic acid that binds to and neutralizes RB006 The binding of RB007 to RB006 causes the predictable and rapid reversal of the RB006 effect and allows the patients blood to return to normal
REG1 is a two-component system consisting of an aptamer-based anticoagulant and its matched antidote The REG1 anticoagulant component RB006 is a single-stranded nucleic acid aptamer RB006 selectively and potently binds to and inhibits Factor IXa a protein critical to blood coagulation The antidote component RB007 is a complementary nucleic acid that binds to and neutralizes RB006 The binding of RB007 to RB006 causes the predictable and rapid reversal of the RB006 effect and allows the patients blood to return to normal
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