Acute Coronary Syndrome (ACS)Phase 2RADARNCT00932100
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
A Phase 2 study testing REG1 and Heparin in people with Acute Coronary Syndrome (ACS), run by Regado Biosciences, Inc. at 43 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- REG1 and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 43 sitesin 4 countries
- Study dates
- Jul 2009to Jan 2011
- 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
- Chest pain or other ischemic symptoms a minimum of 10 minutes in duration within 72 hours before anticipated cardiac catheterization;
- At least one of the following criteria are met:
- New or presumably new ST-segment depression of at least 1 mm or transient (30 minutes) ST-segment elevation of at least 1 mm in 2 contiguous leads;
- Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition
- Documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction
Who cannot join
- Acute ST-segment elevation myocardial infarct
- Anticipated inability to perform angiography within 24 hours of dosing
- Evidence of clinical instability
- Contraindications to anticoagulant use
- Recent cardiac intervention
- Clinically abnormal laboratory or test findings during screening
- Subject is pregnant or lactating
Trial locations and contacts
43 sites in 4 countries.
43 sites in 4 countries
United States26 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
St. Luke's Idaho Cardiology Associates
Boise, Idaho, 83712
Buffalo Heart Group
Buffalo, New York, 14215
University of North Carolina - School of Medicine
Chapel Hill, North Carolina, 27599-7075
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
Heart & Vascular Institute of Florida
Clearwater, Florida, 33756
North Cypress Medical Center
Cypress, Texas, 77429
Henry Ford Health Systems
Detroit, Michigan, 48202
Jim Moran Heart & Vascular Research Institute
Fort Lauderdale, Florida, 33308
Northeast Georgia Heart Center
Gainesville, Georgia, 30501
University of Florida-Medicine Cardiology Research
Gainsville, Florida, 32610-0277
Cardiovascular Institute of the South - Houma
Houma, Louisiana, 70360
Heart Center Research LLC
Huntsville, Alabama, 35801
The Care Group LLC
Indianapolis, Indiana, 46290
University of Florida at Jacksonville
Jacksonville, Florida, 32209
St. Luke's Idaho Cardiology Associates
Meridian, Idaho, 83642
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
Black Hills Clinical Research Center
Rapid City, South Dakota, 57701
Mercy Heart & Vascular Institute
Sacramento, California, 95819
Sutter Medical Center - Sacramento
Sacramento, California, 95819
Scripps Mercy Hospital
San Diego, California, 92103
Swedish Medical Center - Cardiovascular
Seattle, Washington, 98122
Heart Clinics Northwest
Spokane, Washington, 99204
Germany13 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Kardiologische Praxis
Bad Soden, 65812
MVZ am Kuechwald GmbH Ambulantes Herzzentrum
Chemnitz, 9113
Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero
Coburg, 96450
Universitatsklinikum Freiburg Abt. Innere Medizin III
Freiburg im Breisgau, 79106
Klinikum Fulda gAG Medizinische Klinik I
Fulda, 36043
Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III
Halle, 6097
Universitätsklinikum Schleswig-Holstein Kiel
Kiel, 24105
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063
Universitaetsklinik Magdeburg Klinik für Kardiologie Angiologie und Pneumologie
Magdeburg, 39120
Carl-von-Basedow Klinikum
Merseburg, 6217
Klinikum der Universitaet Muenchen Großhadern Medizinische Klinik und Poliklinik I der LMU
München, 81377
Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie
Quedlinburg, 6484
Canada3 sites
Hamilton Health Science
Hamilton, Ontario, L8L 2X2
Montreal Heart Institute Research Center
Montreal, Quebec, H1T 1C8
Vancouver Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.
Read the detailed description
Primary Outcome Bleeding Secondary Outcome Ischemia
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- REG1, Heparin
- Keywords
- ACS, Acute Coronary Syndrome, Catheterization
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REG1Drug
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
HeparinDrug
Also called unfractionated heparin, low molecular weight heparin
IV dose per standard of care at the local institution
| Study group | Role | What they receive |
|---|---|---|
| REG1-a | Experimental | Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) Receives: Drug: REG1 |
| REG1-b | Experimental | Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) Receives: Drug: REG1 |
| REG1-c | Experimental | Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) Receives: Drug: REG1 |
| REG1-d | Experimental | Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) Receives: Drug: REG1 |
| Heparin | Active comparator | Heparin per standard of care at the local institution Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite incidence of major and minor bleeding
Measured: Through Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndrome (ACS)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regado Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John H Alexander, MD MHS FACC, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932100
- Sponsor's protocol ID
- REG-CLIN211
- Acronym
- RADAR
- Status last verified
- Mar 2012
- First submitted
- 1 Jul 2009
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
TCT-176: Access and non-Access Site Bleeding in Acute Coronary Syndrome Patients Treated with a Novel Actively Reversible Factor IXa Inhibitor. Results from the RADAR Trial J Am Coll Cardiol 2011 58: B47
Park 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 30957581Povsic TJ, Vavalle JP, Alexander JH, Aberle LH, Zelenkofske SL, Becker RC, Buller CE, Cohen MG, Cornel JH, Kasprzak JD, Montalescot G, Fail PS, Sarembock IJ, Mehran R; RADAR Investigators. Use of the REG1 anticoagulation system in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the phase II RADAR-PCI study. EuroIntervention. 2014 Aug;10(4):431-8. doi: 10.4244/EIJY14M06_01.
PubMed 24929350Povsic TJ, Cohen MG, Chan MY, Zelenkofske SL, Wargin WA, Harrington RA, Alexander JH, Rusconi CP, Becker RC. Dose selection for a direct and selective factor IXa inhibitor and its complementary reversal agent: translating pharmacokinetic and pharmacodynamic properties of the REG1 system to clinical trial design. J Thromb Thrombolysis. 2011 Jul;32(1):21-31. doi: 10.1007/s11239-011-0588-3.
PubMed 21503856Povsic TJ, Cohen MG, Mehran R, Buller CE, Bode C, Cornel JH, Kasprzak JD, Montalescot G, Joseph D, Wargin WA, Rusconi CP, Zelenkofske SL, Becker RC, Alexander JH. A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. Am Heart J. 2011 Feb;161(2):261-268.e1-2. doi: 10.1016/j.ahj.2010.10.022.
PubMed 21315207
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00932100
- Acronym / sponsor ID
- RADAR / REG-CLIN211
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- ACS, Acute Coronary Syndrome, Catheterization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Regado Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Jul 2009 (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 evaluate the safety and efficacy of the REG1 anticoagulation System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.
Detailed description
Primary Outcome Bleeding Secondary Outcome Ischemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| REG1-a | Experimental | Drug: REG1Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) |
| REG1-b | Experimental | Drug: REG1Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) |
| REG1-c | Experimental | Drug: REG1Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) |
| REG1-d | Experimental | Drug: REG1Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent) |
| Heparin | Active comparator | Drug: HeparinHeparin per standard of care at the local institution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chest pain or other ischemic symptoms a minimum of 10 minutes in duration within 72 hours before anticipated cardiac catheterization;
- At least one of the following criteria are met:
Key exclusion criteria (7 listed)
- Acute ST-segment elevation myocardial infarct
- Anticipated inability to perform angiography within 24 hours of dosing
- Evidence of clinical instability
- Contraindications to anticoagulant use
- Recent cardiac intervention
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 |
|---|---|---|
| REG1IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention | Drug | REG1-a, REG1-b, REG1-c, REG1-d |
| HeparinAlso: unfractionated heparin, low molecular weight heparinIV dose per standard of care at the local institution | Drug | Heparin |
Primary outcome
The composite incidence of major and minor bleeding
Time frame: Through Day 30
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 2 Mar 2012.
- Results publicationTCT-176: Access and non-Access Site Bleeding in Acute Coronary Syndrome Patients Treated with a Novel Actively Reversible Factor IXa Inhibitor. Results from the RADAR Trial J Am Coll Cardiol 2011 58: B47
- 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.
- Derived from this study: PubMed 24929350Povsic TJ, Vavalle JP, Alexander JH, Aberle LH, Zelenkofske SL, Becker RC, Buller CE, Cohen MG, Cornel JH, Kasprzak JD, Montalescot G, Fail PS, Sarembock IJ, Mehran R; RADAR Investigators. Use of the REG1 anticoagulation system in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the phase II RADAR-PCI study. EuroIntervention. 2014 Aug;10(4):431-8. doi: 10.4244/EIJY14M06_01.
- Derived from this study: PubMed 21503856Povsic TJ, Cohen MG, Chan MY, Zelenkofske SL, Wargin WA, Harrington RA, Alexander JH, Rusconi CP, Becker RC. Dose selection for a direct and selective factor IXa inhibitor and its complementary reversal agent: translating pharmacokinetic and pharmacodynamic properties of the REG1 system to clinical trial design. J Thromb Thrombolysis. 2011 Jul;32(1):21-31. doi: 10.1007/s11239-011-0588-3.
- Derived from this study: PubMed 21315207Povsic TJ, Cohen MG, Mehran R, Buller CE, Bode C, Cornel JH, Kasprzak JD, Montalescot G, Joseph D, Wargin WA, Rusconi CP, Zelenkofske SL, Becker RC, Alexander JH. A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. Am Heart J. 2011 Feb;161(2):261-268.e1-2. doi: 10.1016/j.ahj.2010.10.022.
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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.
John H Alexander, MD MHS FACC principal investigator
Duke Clinical Research Institute
43 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REG1 and Heparin in people with Acute Coronary Syndrome (ACS), run by Regado Biosciences, Inc. at 43 sites in 4 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 5 inclusion and 7 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 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, Canada, France. 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?
The composite incidence of major and minor bleeding (time frame: Through Day 30). 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 NCT00932100, which also lists 5 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 2 Mar 2012.