Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI (REVERSAL-PCI)
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).
Coronary Artery Disease
Drug: Unfractionated Heparin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2a, Multi-Center, Open Label, Randomized, Feasibility/Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Subjects Undergoing Elective PCI After Pretreatment With Clopidogrel and Aspirin|
- Major bleeding using the ACUITY bleeding criteria [ Time Frame: until hospital discharge or 48 hours whichever occurs first ] [ Designated as safety issue: Yes ]
- Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR) [ Time Frame: through Day 14 (+/- 3 days) ] [ Designated as safety issue: Yes ]
- Angiographic complications [ Time Frame: through Day 14 (+/- 3 days) ] [ Designated as safety issue: Yes ]
- Femoral Sheath Complications [ Time Frame: until the sheath is pulled ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Unfractionated Heparin
Drug: Unfractionated Heparin
Heparin will be administered per standard of care at sites
Other Name: UFH
Experimental: REG1 Partial Rev.
REG1 with partial reversal
ii. The REG1 anticoagulation system consists of a drug (RB006) and antidote (RB007). The drug (RB006) is administered via IV bolus to achieve anticoagulation. The antidote (RB007) is administered as an IV bolus dose at approximately 10% the total reversal dose followed by the remaining dose several hours later to counteract RB006 induced anticoagulation.
Experimental: REG1 Total Rev.
REG1 with total reversal
ii. The REG1 anticoagulation system consists of a drug (RB006) and antidote (RB007). The drug (RB006) is administered via IV bolus to achieve anticoagulation. The antidote (RB007) is administered as an IV bolus dose at 100% of the total reversal dose to counteract RB006 induced anticoagulation.
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 patient's blood to return to normal.
|United States, Indiana|
|The Care Group, LLC|
|Indianapolis, Indiana, United States, 46290|
|United States, Michigan|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Pennsylvania|
|Danville, Pennsylvania, United States, 17822|
|United States, South Dakota|
|Black Hills Clinical Research Center|
|Rapid City, South Dakota, United States, 57701|
|Buenos Aires, Argentina|