account_circleRecruiting
Thrombolysis, Symptomatic proximal deep vein thrombosis
Bayer Identifier:
22138
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2023-503315-15-00
A study to learn more about how well BAY3018250 works and how safe it is for people with proximal deep vein thrombosis
Trial purpose
Researchers are looking for a better way to treat people who have deep vein thrombosis (DVT).
DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called ‘proximal’ when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT.
BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors.
The main purposes of this study are to learn:
• How well BAY3018250 works in dissolving blood clots in participants with proximal DVT and
• How safe is BAY3018250 as a treatment for participants with proximal DVT?
For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time.
And researchers will collect the number of bleeding events that require medical attention.
The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo.
Researchers will closely monitor participants for 90 days after receiving the study treatment.
During the study, the doctors and their study team will:
• take blood samples
• do physical examinations
• examine heart health using electrocardiogram (ECG)
• check vital signs such as blood pressure, heart rate
• undergo ultrasound tests to measure the blood clots
• ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called ‘proximal’ when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT.
BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors.
The main purposes of this study are to learn:
• How well BAY3018250 works in dissolving blood clots in participants with proximal DVT and
• How safe is BAY3018250 as a treatment for participants with proximal DVT?
For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time.
And researchers will collect the number of bleeding events that require medical attention.
The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo.
Researchers will closely monitor participants for 90 days after receiving the study treatment.
During the study, the doctors and their study team will:
• take blood samples
• do physical examinations
• examine heart health using electrocardiogram (ECG)
• check vital signs such as blood pressure, heart rate
• undergo ultrasound tests to measure the blood clots
• ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
255Trial Dates
January 2024 - October 2025Phase
Phase 2Could I Receive a placebo
YesProducts
BAY3018250Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine | Reggio Emilia, 42122, Italy |
Recruiting | Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione | Bologna, 40138, Italy |
Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche | Roma, 00168, Italy |
Not yet recruiting | ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi | Varese, 21100, Italy |
Recruiting | AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso | Treviso, 31100, Italy |
Recruiting | Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico | Padova, 35128, Italy |
Recruiting | Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department | Castelfranco Veneto, <unknown>, Italy |
Recruiting | Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie | Dresden, 01307, Germany |
Not yet recruiting | Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin | Berlin, 12203, Germany |
Withdrawn | Franziskus-Krankenhaus Berlin | Klinik für Innere Medizin | Berlin, 10787, Germany |
Recruiting | LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie | Muenchen, 80336, Germany |
Withdrawn | Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III | Angiologie | Mainz, 55131, Germany |
Withdrawn | Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik | Bereich Haemostaseologie | Hamburg, 20246, Germany |
Suspended | Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie | Muenster, 48149 Münster, Germany |
Recruiting | AZ Groeninge - Campus Kennedylaan | Kortrijk, 8500, Belgium |
Not yet recruiting | Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman | Liege, 4000, Belgium |
Recruiting | Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB) | Leuven, 3000, Belgium |
Recruiting | UZ Gent | GENT, 9000, Belgium |
Recruiting | Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling | Antwerp, 2650, Belgium |
Recruiting | Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department | Genk, 3600, Belgium |
Recruiting | AZ Sint-Maarten | Mechelen, 2800, Belgium |
Not yet recruiting | McGill University Health Centre – Glen Site | Montreal, H4A 3J1, Canada |
Withdrawn | Hamilton Health Sciences - Hamilton General Hospital (HGH) | Hamilton, L8L 2X2, Canada |
Withdrawn | Niagara Health - St. Catharines Site | St. Catharines, L2S 0A9, Canada |
Recruiting | Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil | Toulouse, 31059, France |
Recruiting | Hôpital Louis Mourier - Colombes Cedex | Colombes, 92701, France |
Recruiting | Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC) | Strasbourg, 67091, France |
Recruiting | Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche | Brest, 29609, France |
Recruiting | Groupe Hospitalier Sud - Amiens | AMIENS cedex1, 80054, France |
Recruiting | Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Europeen Georges-Pompidou (HEGP) | Paris, 75908, France |
Recruiting | Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied | Clermont Ferrand, 63003, France |
Recruiting | Hôpital Sainte Musse | Toulon, 83100, France |
Not yet recruiting | Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon | La Tronche, 38700, France |
Recruiting | Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord | Saint Etienne, 42000, France |
Withdrawn | CHU Rennes, H Pontchaillou, Cardiologie | Rennes, 35033, France |
Recruiting | Albert Schweitzer Hospital | Internal Medicine - Hematology Department | Dordrecht, 3318 AT, Netherlands |
Withdrawn | Isala | Zwolle, 8025AB, Netherlands |
Recruiting | Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center) | Leiden, 2300 RC, Netherlands |
Not yet recruiting | Radboud University Medical Center | Afdeling Interne Geneeskunde | Nijmegen, 6500 HB, Netherlands |
Withdrawn | Maastricht University Medical Center | School for Cardiovascular Diseases - Biochemie | Maastricht, 6229 HX, Netherlands |
Not yet recruiting | Rijnstate | Arnhem - Internal Medicine Department - Vascular Research | Arnhem, 6815 AD, Netherlands |
Recruiting | Zuyderland Medical Centre | Internal Medicine Department | Geleen, 6162 BG, Netherlands |
Recruiting | Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche | Rozzano, 20089, Italy |
Recruiting | Imelda - Vascular Surgery Dept | Bonheiden, 2820, Belgium |
Not yet recruiting | UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie | Bad Krozingen, 79189, Germany |
Withdrawn | Kardiologicka a interni ambulance - Ostrava | Ostrava, 70852, Czech Republic |
Not yet recruiting | Nemocnice Mlada Boleslav - interni oddeleni | Mlada Boleslav, 293 01, Czech Republic |
Recruiting | II. interni klinika - klinika kardiologie a angiologie 1. lekarske fakulty a Vseobecne fakultni nemocnice | Praha 2, 128 08, Czech Republic |
Not yet recruiting | II. interni klinika, Cevni ambulance (angiologicka ambulance), Fakultni nemocnice u sv. Anny v Brne | Brno, 602 00, Czech Republic |
Withdrawn | Oddeleni standardni kardiologie, Nemocnice Na Homolce | Praha 5, 150 30, Czech Republic |
Recruiting | Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace | Krnov, 794 01, Czech Republic |
Recruiting | Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady | Praha 10, 100 34, Czech Republic |
Not yet recruiting | Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace | Znojmo, 669 02, Czech Republic |
Not yet recruiting | Nemocnice Roudnice nad Labem - interni oddeleni | Roudnice nad Labem, 41301, Czech Republic |
Withdrawn | Stredoslovenský ústav srdcových a cievnych chorôb, a.s. - Oddelenie angiológie | Banská Bystrica, 974 01, Slovakia |
Recruiting | Hospitale, s.r.o. - Interné oddelenie | Šahy, 936 01, Slovakia |
Not yet recruiting | Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department | Spišská Nová Ves, 052 01, Slovakia |
Recruiting | Kardiocentrum AGEL a.s. - Angiologické oddelenie | Košice, 040 15, Slovakia |
Recruiting | Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia | Košice, 040 01, Slovakia |
Recruiting | Nemocnicná a.s. - Interné oddelenie | Malacky, 901 22, Slovakia |
Not yet recruiting | Penta Hospitals | Rimavska Sobota Hospital - Internal Medicine Department | Rimavská Sobota, 979 01, Slovakia |
Not yet recruiting | Hospital Universitario de Navarra- Medicina Interna | Pamplona, 31008, Spain |
Not yet recruiting | Hospital Universitario Infanta Sofia-Medicina Interna | San Sebastian de los Reyes, 28702, Spain |
Not yet recruiting | Hospital Universitario la Paz-Medicina Interna | Madrid, 28046, Spain |
Recruiting | Hospital Universitari De Girona Doctor Josep Trueta-Medicina Interna | Girona, 17007, Spain |
Suspended | Krajská zdravotní, Masarykova nemocnice Ústí nad Labem - Kardiologická jednotka intenzivní péce | Usti nad Labem, 400 11, Czech Republic |
Recruiting | Vojenska nemocnice Brno - kardiologicke interni oddeleni | Brno, 615 00, Czech Republic |
Not yet recruiting | MHAT National Heart Hospital EAD | Sofia, 1309, Bulgaria |
Not yet recruiting | University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD | Sofia, 1431, Bulgaria |
Recruiting | University Multiprofile Hospital For Active Treatment 'Sveta Ekaterina' EAD | Sofia, 1431, Bulgaria |
Not yet recruiting | Medical Institute Ministry of Interior | Sofia, 1606, Bulgaria |
Not yet recruiting | Specialized Hospital For Active Cardiology Treatment Medica Kor EAD | Ruse, 7013, Bulgaria |
Recruiting | University Multiprofile Hospital For Active Treatment Kanev AD | Ruse, 7002, Bulgaria |
Recruiting | Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department | Veliko Tarnovo, 5000, Bulgaria |
Withdrawn | Pecsi Tudomanyegyetem Klinikai Kozpont - I. sz. Belgyogyaszati Klinika | Pecs, 7624, Hungary |
Not yet recruiting | Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat | Székesfehérvár, 8000, Hungary |
Withdrawn | Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz - Kardiovaszkularis es Belgyogyaszati centrum | Miskolc, 3526, Hungary |
Not yet recruiting | Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz | Békéscsaba, 5600, Hungary |
Recruiting | Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály | Kaposvár, 7400, Hungary |
Recruiting | Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia | Kistarcsa, 2143, Hungary |
Not yet recruiting | Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika | Szeged, 6725, Hungary |
Not yet recruiting | Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia | Budapest, 1088, Hungary |
Recruiting | Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi | Istanbul, 34098, Turkey |
Not yet recruiting | Ankara Bilkent Sehir Hastanesi | Bilkent ankara, 6800, Turkey |
Recruiting | Erciyes Universitesi Tip Fakultesi | Kayseri, 38039, Turkey |
Suspended | Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit | Istanbul, 34846, Turkey |
Recruiting | Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi | Istanbul, 34744, Turkey |
Recruiting | Izmir Sehir Hastanesi | Izmir, 35540, Turkey |
Not yet recruiting | Bagcilar Egitim ve Arastirma Hastanesi | Istanbul, 34200, Turkey |
Not yet recruiting | University General Hospital of Larissa - Department of Vascular surgery of University of Thessaly | Larissa, 41110, Greece |
Not yet recruiting | University General Hospital Attikon - 1st Department of Vascular surgery University of Athens | Athens, 124 62, Greece |
Not yet recruiting | General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery | Efkarpia, 564 29, Greece |
Recruiting | University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty | Ioannina, 455 00, Greece |
Not yet recruiting | General Hospital Of Athens G Gennimatas- Department of Vascular Surgery | Athens, 115 27, Greece |
Recruiting | General University Hospital Of Patras- Department of Vascular Surgery | Patras, 265 04, Greece |
Suspended | Penta Hospitals | Nemocnica Bory - Department of Internal Medicine | Bratislava, 841 03, Slovakia |
Primary Outcome
- AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasoundArea under the curve (AUC) with respect to the measurement time points at 6 hours, 24 hours, 7 days and 30 days of the ratio to baseline of clot burdendate_rangeTime Frame:at 6 hours, 24 hours, Day 7, Day 30
- Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition)The classify of bleeding events use the International Society on Thrombosis and Haemostasis (ISTH) definitions.date_rangeTime Frame:up to Day 15
Secondary Outcome
- Ratio to baseline of clot burden, as assessed by quantitative ultrasounddate_rangeTime Frame:at 6 hours, 24 hours, Day 7, Day 30 and Day 90
- Change from baseline in leg pain severityLikert pain scale is used as a quantitative measure of patient reported pain based on the participant´s judgement. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).date_rangeTime Frame:at 6 hours, 24 hours, Day 7, Day 30 and Day 90
- Change from baseline in PVFS scalePVFS stands for post venous thromboembolism functional status. PVFS scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), with higher scores being worse and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle.date_rangeTime Frame:at Day 7, Day 30 and Day 90
- Number of participants with recurrent venous thromboembolismdate_rangeTime Frame:up to Day 90
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3