Coronary Artery DiseasePhase 2REVERSAL-PCINCT00715455
Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI
A Phase 2 study testing REG1 and Unfractionated Heparin in people with Coronary Artery Disease, run by Regado Biosciences, Inc. at 6 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- REG1 and Unfractionated Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
UNC
Chapel Hill, North Carolina, 27599
Geisinger
Danville, Pennsylvania, 17822
Henry Ford
Detroit, Michigan, 48202
The Care Group, LLC
Indianapolis, Indiana, 46290
Black Hills Clinical Research Center
Rapid City, South Dakota, 57701
About this study
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
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).
Read the 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 patient's blood to return to normal.
- Conditions
- Coronary Artery Disease
- Being tested
- REG1, Unfractionated Heparin
- Keywords
- CAD, PCI, ANTICOAGULANT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REG1Drug
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.
REG1Drug
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.
Unfractionated HeparinDrug
Also called UFH
Heparin will be administered per standard of care at sites
| Study group | Role | What they receive |
|---|---|---|
| Unfractionated Heparin | Active comparator | Unfractionated Heparin Receives: Drug: Unfractionated Heparin |
| REG1 Partial Rev. | Experimental | REG1 with partial reversal Receives: Drug: REG1 |
| REG1 Total Rev. | Experimental | REG1 with total reversal Receives: Drug: REG1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding using the ACUITY bleeding criteria
Measured: until hospital discharge or 48 hours whichever occurs first
Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR)
Measured: through Day 14 (+/- 3 days)
Secondary outcomes (2)
Angiographic complications
Measured: through Day 14 (+/- 3 days)
Femoral Sheath Complications
Measured: until the sheath is pulled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regado Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715455
- Sponsor's protocol ID
- REG1-CLIN210
- Acronym
- REVERSAL-PCI
- Status last verified
- May 2013
- First submitted
- 14 Feb 2008
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20660806Park 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.
PubMed 30957581
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00715455
- Acronym / sponsor ID
- REVERSAL-PCI / REG1-CLIN210
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, PCI, ANTICOAGULANT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Regado Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's blood to return to normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unfractionated Heparin | Active comparator | Drug: Unfractionated HeparinUnfractionated Heparin |
| REG1 Partial Rev. | Experimental | Drug: REG1REG1 with partial reversal |
| REG1 Total Rev. | Experimental | Drug: REG1REG1 with total reversal |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REG1ii. 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 Partial Rev. |
| REG1ii. 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 | REG1 Total Rev. |
| Unfractionated HeparinAlso: UFHHeparin will be administered per standard of care at sites | Drug | Unfractionated Heparin |
Primary outcome
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)
2 secondary outcomes
Angiographic complications
Time frame: through Day 14 (+/- 3 days)
Femoral Sheath Complications
Time frame: until the sheath is pulled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Results publication: PubMed 20660806Cohen 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.
- Derived from this study: PubMed 30957581Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REG1 and Unfractionated Heparin in people with Coronary Artery Disease, run by Regado Biosciences, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleeding using the ACUITY bleeding criteria (time frame: until hospital discharge or 48 hours whichever occurs first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715455, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.