Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI
REVERSAL-PCI
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
1 other identifier
interventional
26
2 countries
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 coronary-artery-disease
Started Oct 2007
Shorter than P25 for phase_2 coronary-artery-disease
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedMay 31, 2013
May 1, 2013
1 year
February 14, 2008
May 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Major bleeding using the ACUITY bleeding criteria
until hospital discharge or 48 hours whichever occurs first
Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR)
through Day 14 (+/- 3 days)
Secondary Outcomes (2)
Angiographic complications
through Day 14 (+/- 3 days)
Femoral Sheath Complications
until the sheath is pulled
Study Arms (3)
Unfractionated Heparin
ACTIVE COMPARATORUnfractionated Heparin
REG1 Partial Rev.
EXPERIMENTALREG1 with partial reversal
REG1 Total Rev.
EXPERIMENTALREG1 with total reversal
Interventions
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.
Heparin will be administered per standard of care at sites
Eligibility Criteria
You may qualify if:
- Males or females scheduled for non-urgent elective PCI (who do not have certain cardiac parameters) and have not been treated with UHF prior to PCI.
- Subject able to give informed consent and comply with the protocol.
- Negative urine pregnancy test or documented surgical sterilization or menopausal.
You may not qualify if:
- Subject weight \>120 kg.
- Recent acute coronary syndrome with elevated cardiac markers or ST segment depression at rest.
- Evidence of clinical instability
- Angiographic high-risk.
- A contraindication to anticoagulation or increased risk of bleeding.
- Use of prohibited medications or investigational drugs prior to the study.
- Clinically significant abnormal laboratory findings.
- Planned use of femoral sheath greater than a certain size.
- Known allergy or intolerance to drugs mandated by the study.
- Use of devices other than angioplasty balloons and coronary stents.
- A history of licit drug abuse or illicit drug use or current evidence of such abuse.
- Any other factor that the Investigator feels would put the subject at increased risk if participating in the protocol.
- Lactation.
- Currently enrolled in this or another clinical trial (with some exceptions).
- Participation in an investigational drug or device trial in the past 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
The Care Group, LLC
Indianapolis, Indiana, 46290, United States
Henry Ford
Detroit, Michigan, 48202, United States
UNC
Chapel Hill, North Carolina, 27599, United States
Geisinger
Danville, Pennsylvania, 17822, United States
Black Hills Clinical Research Center
Rapid City, South Dakota, 57701, United States
H. Italiano
Buenos Aires, Argentina
Related Publications (2)
Cohen MG, Purdy DA, Rossi JS, Grinfeld LR, Myles SK, Aberle LH, Greenbaum AB, Fry E, Chan MY, Tonkens RM, Zelenkofske S, Alexander JH, Harrington RA, Rusconi CP, Becker RC. First clinical application of an actively reversible direct factor IXa inhibitor as an anticoagulation strategy in patients undergoing percutaneous coronary intervention. Circulation. 2010 Aug 10;122(6):614-22. doi: 10.1161/CIRCULATIONAHA.109.927756. Epub 2010 Jul 26.
PMID: 20660806RESULTPark EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PMID: 30957581DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2008
First Posted
July 15, 2008
Study Start
October 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 31, 2013
Record last verified: 2013-05