Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI (REVERSAL-PCI)
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|ClinicalTrials.gov Identifier: NCT00715455|
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: REG1 Drug: Unfractionated Heparin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
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.
- Major bleeding using the ACUITY bleeding criteria [ Time Frame: until hospital discharge or 48 hours whichever occurs first ]
- Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR) [ Time Frame: through Day 14 (+/- 3 days) ]
- Angiographic complications [ Time Frame: through Day 14 (+/- 3 days) ]
- Femoral Sheath Complications [ Time Frame: until the sheath is pulled ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715455
|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|