NCT00715455 - Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions

Coronary Artery Disease

Interventions

DRUG

REG1

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.

DRUG

REG1

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.

DRUG

Unfractionated Heparin

Heparin will be administered per standard of care at sites

Trial Locations (6)

17822

Geisinger, Danville

27599

UNC, Chapel Hill

46290

The Care Group, LLC, Indianapolis

48202

Henry Ford, Detroit

57701

Black Hills Clinical Research Center, Rapid City

Unknown

H. Italiano, Buenos Aires

All Listed Sponsors

lead

Regado Biosciences, Inc.

INDUSTRY