Peripheral Endovascular InterventionsPhase 3ENDOMAXNCT01913483
ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
A Phase 3 study testing Bivalirudin and Unfractionated Heparin in people with Peripheral Endovascular Interventions and Bleeding, run by The Medicines Company at 39 sites in United States.
Trial summary
The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Endovascular Interventions, Bleeding
- What is being tested?
- Bivalirudin and Unfractionated Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- 39 sitesUnited States
- Study dates
- 24 Sep 2013to 16 Mar 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants ≥ 18 years of age
- Must be undergoing one of the following PEI procedures:
- Carotid artery stenting
- Lower Extremity Interventions (LEI) for Critical Limb Ischemia
- LEI for claudication
- Provide written informed consent prior to any study-specific procedure being performed
Who cannot join
- Any known contra-indication to the use of bivalirudin or UFH
- Acute limb ischemia
- Planned amputation regardless of the outcome of the PEI
- Dialysis dependent
- Weight less than 38 kg or more than 202 kg
- History of any bleeding diathesis or severe hematological disease
Show all 20Show fewer
- History of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage
- Gastrointestinal or genitourinary bleeding within the 30 days prior to randomization
- Any surgery (excluding punch or shave skin biopsy) within the 30 days prior to randomization
- Concomitant percutaneous coronary intervention
- Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization
- International normalized ratio >1.7 within 24 h prior to the index procedure
- Administration of therapeutic doses of UFH within 30 min prior to the index procedure (a low dose [≤2000 U] of heparin is permitted during the diagnostic angiogram prior to the intervention)
- Administration of enoxaparin within 8 h; other low molecular weight heparins or fondaparinux within 24 h; any oral anti-Xa or antithrombin agent within 48 h; or thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index procedure
- Severe contrast allergy that cannot be pre-medicated
- Procedures performed by radial access when they are intended as the primary access site for the index procedure
- Known or suspected pregnant women or nursing mothers
- Previous enrollment in this study (MDCO-BIV-12-03)
- Participation in other investigational drug or device trials within 30 days prior to randomization
- Participants who, for any reason, are deemed by the investigator to be inappropriate for this study
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
INOVA Alexandria Hospital
Alexandria, Virginia, 22304
AnMed Health
Anderson, South Carolina, 29621
Kentucky Heart Foundation - King's Daughters Medical Center
Ashland, Kentucky, 41101
Tufts Medical Center
Boston, Massachusetts, 02111
VA Boston Healthcare System
Boston, Massachusetts, 02132
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Medical University of South Carolina
Charleston, South Carolina, 29425
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Cincinnati
Cincinnati, Ohio, 45267
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, 33756
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Florida Research Network
Gainesville, Florida, 32605
The Cardiac and Vascular Institute
Gainesville, Florida, 32605
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
Tri-Lakes Research
Hot Springs, Arkansas, 71901
Cape Cod Research Institute
Hyannis, Massachusetts, 02601
Texas Tech University Health Science Center
Lubbock, Texas, 79430
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Weill Cornell Medical College
New York, New York, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Alpine Research
Ogden, Utah, 84403
Integris - Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Florida Hospital
Orlando, Florida, 32803
Peoria Radiology Research & Education Foundation
Peoria, Illinois, 61637
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55905
Swedish Medical Center
Seattle, Washington, 98122
Stanford Hospital and Clinics
Stanford, California, 94305-5407
Stony Brook Medicine
Stony Brook, New York, 11794
Holy Name Medical Center
Teaneck, New Jersey, 07666
Scott and White Hospital
Temple, Texas, 76508
Jobst Vascular Institute
Toledo, Ohio, 43606
Michigan Heart
Ypsilanti, Michigan, 48197
About this study
The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.
- Conditions
- Peripheral Endovascular Interventions, Bleeding
- Being tested
- Bivalirudin, Unfractionated Heparin
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Also called AngioMAX, Angiox
Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.
Unfractionated HeparinDrug
Also called Heparin
Unfractionated heparin is an anticoagulant.
| Study group | Role | What they receive |
|---|---|---|
| Bivalirudin | Experimental | Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters/minute [mL/min]). Receives: Drug: Bivalirudin |
| Unfractionated Heparin | Active comparator | UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use. Receives: Drug: Unfractionated Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)
BARC ≥3 includes:
Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision.
Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period.
Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death.
Measured: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
Secondary outcomes (2)
Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration
Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3).
In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation.
Measured: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC.
In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation.
Measured: Study drug initiation (Day 1) up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study start24 Sep 2013
- Primary completion16 Mar 2016
- Study completion16 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Endovascular InterventionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 732 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913483
- Sponsor's protocol ID
- MDCO-BIV-12-03
- Acronym
- ENDOMAX
- Status last verified
- Apr 2017
- First submitted
- 30 Jul 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
- ClinicalTrials.gov ID
- NCT01913483
- Acronym / sponsor ID
- ENDOMAX / MDCO-BIV-12-03
- Conditions
- Peripheral Endovascular Interventions, Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 732 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2013 (actual)
- Primary completion
- 16 Mar 2016 (actual)
- Study completion
- 16 Mar 2016 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Experimental | Drug: BivalirudinBivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters/minute [mL/min]). |
| Unfractionated Heparin | Active comparator | Drug: Unfractionated HeparinUFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants ≥ 18 years of age
- Must be undergoing one of the following PEI procedures:
- Provide written informed consent prior to any study-specific procedure being performed
Key exclusion criteria (20 listed)
- Any known contra-indication to the use of bivalirudin or UFH
- Acute limb ischemia
- Planned amputation regardless of the outcome of the PEI
- Dialysis dependent
- Weight less than 38 kg or more than 202 kg
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 |
|---|---|---|
| BivalirudinAlso: AngioMAX, AngioxBivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion. | Drug | Bivalirudin |
| Unfractionated HeparinAlso: HeparinUnfractionated heparin is an anticoagulant. | Drug | Unfractionated Heparin |
Primary outcome
Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)
Time frame: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
BARC ≥3 includes: Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision. Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period. Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death.
2 secondary outcomes
Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration
Time frame: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
Time frame: Study drug initiation (Day 1) up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bivalirudin and Unfractionated Heparin in people with Peripheral Endovascular Interventions and Bleeding, run by The Medicines Company at 39 sites in United States.
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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC) (time frame: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.