Severe Aortic StenosisPhase 3BRAVO 2/3NCT01651780
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
A Phase 3 study testing Bivalirudin and Unfractionated Heparin in people with Severe Aortic Stenosis and Transcatheter Aortic Valve Replacement, run by The Medicines Company at 33 sites in 7 countries.
Trial summary
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
- 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
- 803 participants
- Where
- 33 sitesin 7 countries
- Study dates
- Oct 2012to Jun 2015
- 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
- Males and females, ≥18 years of age
- High risk (Euroscore ≥18, or considered inoperable) for surgical aortic valve replacement
- Undergoing TAVR via transfemoral arterial access
- Provide written informed consent before initiation of any study related procedures
Who cannot join
- Any known contra-indication to the use of bivalirudin (except presence of severe renal impairment [glomerular filtration rate (GFR) <30 milliliters (mL)/minute] since these participants will be included in the trial or UFH
- Refusal to receive blood transfusion
- Mechanical valve (any location) or mitral bioprosthetic valve
- Extensive calcification of the common femoral artery, or minimal luminal diameter <6.5 millimeters (mm)
- Use of elective surgical cut-down for transfemoral access
- Concurrent performance of percutaneous coronary intervention with TAVR
Show all 29Show fewer
- International normalized ratio (INR) ≥2 on the day of TAVR procedure or known history of bleeding diathesis
- History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation
- Severe left ventricular dysfunction (left ventricular ejection fraction <15%)
- Severe aortic regurgitation or mitral regurgitation (4+)
- Hemodynamic instability (for example, requiring inotropic or intra-aortic balloon pump support) within 2 hours of the procedure
- Dialysis dependent
- Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure
- Acute myocardial infarction, major surgery, or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days
- Percutaneous coronary intervention within 30 days
- Upper gastrointestinal or genitourinary bleed within 30 days
- Stroke or transient ischemic attack within 30 days
- Any surgery or biopsy within 2 weeks
- Administration of:
- UFH within 30 minutes of the procedure
- Enoxaparin within 8 hours of the procedure
- Fondaparinux or other low-molecular-weight heparins (LMWHs) within 24 hours of the procedure
- Dabigatran, rivaroxaban, or other oral anti-Xa or antithrombin agent within 48 hours of the procedure
- Thrombolytics, glycoprotein IIb/IIIa inhibitor, or warfarin within 72 hours of the procedure
- Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast
- Contraindications or allergy to aspirin or clopidogrel
- Known or suspected pregnant women or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy
- Previous enrollment in this study
- Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
Germany13 sites
Universitätsklinikum Bonn
Bonn, 53105
Klinikum links der Weser Bremen
Bremen, 28277
Elisabeth-Krankenhaus Essen
Essen, 45257
Freiburg University
Freiburg im Breisgau, 79106
Asklepios St. Georg Hamburg
Hamburg, 20099
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625
University Heart Centre, Clinic of Inner Medicine 1 Cardiology
Jena, Lobeda Ost, 07747
Universität Leipzig - Herzzentrum GmbH
Leipzig, 04289
Universitätsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, 55131
Deutsches Herzzentrum München
München, 80636
LMU Munich, Klinikum der Universität München
Munich, 81377
Helios Heart Center Siegburg
Siegburg, 53721
France7 sites
CHU Jean Minjoz, Service de Cardiologie
Besançon, 25000
Centre Hospitalier de Lyon
Bron, 69500
Department of Cardiology, CHRU Lille
Lille, 59037
Institut Hospitalier Jacques Cartier
Massy, 91300
Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle
Rouen, 76031
Clinique Pasteur, Unité de Cardiologie Interventionnelle
Toulouse, Cedex 3, 31076
CHU de Toulouse
Toulouse, Cedex 9, 31059
Italy5 sites
Ferraroto Hospital, University of Catania
Catania, 95123
Ospedale San Raffaele U.O. Cardiologia Interventistica
Milan, 20132
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56124
Azienda Ospedaliera San Camillo-Forlanini
Roma, 00151
Policlinico Umberto I, Università La Sapienza
Roma
Canada2 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
St. Paul´s Hospital Providence Health Care
Vancouver, V6Z1Y6
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, 3435
University Medical Center Utrecht
Utrecht, 3584 CX
Switzerland2 sites
Cardiology University Hospital Basel
Basel, CH-4031
Universitätsklinik Bern
Bern, 3010
United Kingdom2 sites
The Royal Sussex County Hospital
Brighton, East Sussex, BN2 5BE
Hammersmith Hospital
London, W12 0HS
About this study
Official title: Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.
- Being tested
- Bivalirudin, Unfractionated Heparin
- Keywords
- Transcatheter aortic valve replacement, Aortic valve replacement, Severe aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis
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 administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. Receives: Drug: Bivalirudin |
| Unfractionated heparin (UFH) | Active comparator | The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. Receives: Drug: Unfractionated Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge
Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows:
- Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade.
- BARC 3c includes intracranial or intraocular bleeds that compromised vision.
- BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period.
- BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause.
Measured: at 48 hours or discharge, whichever occurs first
Net Adverse Clinical Events (NACE) at up to 30 Days
The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.
Measured: up to 30 days after procedure
Secondary outcomes (10)
NACE at 48 Hours or Before Hospital Discharge
NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.
Measured: at 48 hours or before hospital discharge, whichever occurred earlier
Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke
The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented.
Measured: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)
Percentage of participants with major bleeding according to the following scales:
- Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding
- Thrombolysis in Myocardial Infarction (TIMI)=major bleeding
- Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate
- Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding
Measured: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Transient Ischemic Attack
The percentage of participants reporting transient ischemic attack is presented.
Measured: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Acute Kidney Injury
The percentage of participants reporting acute kidney injury is presented.
Measured: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Major Vascular Complications
The percentage of participants reporting a major vascular complications as defined by VARC is presented.
Measured: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Acquired Thrombocytopenia
The percentage of participants reporting acquired thrombocytopenia is presented.
Measured: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
New Onset Atrial Fibrillation/Flutter
The percentage of participants reporting new onset atrial fibrillation/flutter is presented.
Measured: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge
The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented.
Measured: Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)
Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor
The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented.
Measured: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2015
- Study completionJun 2015
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic StenosisStudies 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
- None (open label)
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry Lefevre, MD, Principal investigator, Hôpital Privé Jacques CartierEberhardt Grube, MD, Principal investigator, University Hospital, BonnGeorge D Dangas, MD, PhD, Study director, The Zena and Michael A. Wiener Cardiovascular InstituteProdromos Anthopoulos, MD, Study director, The Medicines Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651780
- Sponsor's protocol ID
- TMC-BIV-11-02
- Other IDs
- 2012-000632-26
- Acronym
- BRAVO 2/3
- Status last verified
- Mar 2017
- First submitted
- 24 Jul 2012
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Van Belle E, Hengstenberg C, Lefevre T, Kupatt C, Debry N, Husser O, Pontana F, Kuchcinski G, Deliargyris EN, Mehran R, Bernstein D, Anthopoulos P, Dangas GD; BRAVO-3 MRI Study Investigators. Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study. J Am Coll Cardiol. 2016 Aug 9;68(6):589-599. doi: 10.1016/j.jacc.2016.05.006. Epub 2016 May 18.
PubMed 27208464Dangas GD, Lefevre T, Kupatt C, Tchetche D, Schafer U, Dumonteil N, Webb JG, Colombo A, Windecker S, Ten Berg JM, Hildick-Smith D, Mehran R, Boekstegers P, Linke A, Tron C, Van Belle E, Asgar AW, Fach A, Jeger R, Sardella G, Hink HU, Husser O, Grube E, Deliargyris EN, Lechthaler I, Bernstein D, Wijngaard P, Anthopoulos P, Hengstenberg C; BRAVO-3 Investigators. Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2860-2868. doi: 10.1016/j.jacc.2015.10.003. Epub 2015 Oct 15.
PubMed 26477635
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)
- ClinicalTrials.gov ID
- NCT01651780
- Acronym / sponsor ID
- BRAVO 2/3 / TMC-BIV-11-02
- Keywords
- Transcatheter aortic valve replacement, Aortic valve replacement, Severe aortic stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Posted 27 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Experimental | Drug: BivalirudinBivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. |
| Unfractionated heparin (UFH) | Active comparator | Drug: Unfractionated HeparinThe dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, ≥18 years of age
- High risk (Euroscore ≥18, or considered inoperable) for surgical aortic valve replacement
- Undergoing TAVR via transfemoral arterial access
- Provide written informed consent before initiation of any study related procedures
Key exclusion criteria (29 listed)
- Any known contra-indication to the use of bivalirudin (except presence of severe renal impairment [glomerular filtration rate (GFR) <30 milliliters (mL)/minute] since these participants will be included in the trial or UFH
- Refusal to receive blood transfusion
- Mechanical valve (any location) or mitral bioprosthetic valve
- Extensive calcification of the common femoral artery, or minimal luminal diameter <6.5 millimeters (mm)
- Use of elective surgical cut-down for transfemoral access
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 (UFH) |
Primary outcome
Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge
Time frame: at 48 hours or discharge, whichever occurs first
Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows: * Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade. * BARC 3c includes intracranial or intraocular bleeds that compromised vision. * BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period. * BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause.
Net Adverse Clinical Events (NACE) at up to 30 Days
Time frame: up to 30 days after procedure
The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.
10 secondary outcomes
NACE at 48 Hours or Before Hospital Discharge
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier
Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)
Time frame: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Transient Ischemic Attack
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Acute Kidney Injury
Time frame: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Major Vascular Complications
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Acquired Thrombocytopenia
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
New Onset Atrial Fibrillation/Flutter
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge
Time frame: Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)
Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor
Time frame: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27208464Van Belle E, Hengstenberg C, Lefevre T, Kupatt C, Debry N, Husser O, Pontana F, Kuchcinski G, Deliargyris EN, Mehran R, Bernstein D, Anthopoulos P, Dangas GD; BRAVO-3 MRI Study Investigators. Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study. J Am Coll Cardiol. 2016 Aug 9;68(6):589-599. doi: 10.1016/j.jacc.2016.05.006. Epub 2016 May 18.
- Derived from this study: PubMed 26477635Dangas GD, Lefevre T, Kupatt C, Tchetche D, Schafer U, Dumonteil N, Webb JG, Colombo A, Windecker S, Ten Berg JM, Hildick-Smith D, Mehran R, Boekstegers P, Linke A, Tron C, Van Belle E, Asgar AW, Fach A, Jeger R, Sardella G, Hink HU, Husser O, Grube E, Deliargyris EN, Lechthaler I, Bernstein D, Wijngaard P, Anthopoulos P, Hengstenberg C; BRAVO-3 Investigators. Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2860-2868. doi: 10.1016/j.jacc.2015.10.003. Epub 2015 Oct 15.
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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.
Thierry Lefevre, MD principal investigator
Hôpital Privé Jacques Cartier
Eberhardt Grube, MD principal investigator
University Hospital, Bonn
George D Dangas, MD, PhD study director
The Zena and Michael A. Wiener Cardiovascular Institute
33 sites in 7 countries: 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 Severe Aortic Stenosis and Transcatheter Aortic Valve Replacement, run by The Medicines Company at 33 sites in 7 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 4 inclusion and 29 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, France, Italy, Canada, Netherlands and 2 more countries. 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 27 Feb 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?
Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge (time frame: at 48 hours or discharge, 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 NCT01651780, 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 7 Apr 2017.