Trial Condition(s):
Thrombolysis, Symptomatic proximal deep vein thrombosis
A study to learn more about how well BAY3018250 works and how safe it is for people with proximal deep vein thrombosis (SIRIUS)
Bayer Identifier:
22138
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2023-503315-15-00
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.
Inclusion Criteria
- Male and female (if postmenopausal or hysterectomized) aged 18 years or older - Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following: -- duration of symptoms 14 days or less -- Proximal DVT involving at least 1 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac vein -- adequate visualization of the most proximal end of the thrombus -- receiving therapeutic dose anticoagulation with low molecular weight heparins (LMWHs) and/or direct oral anticoagulants (DOACs) according to the respective product labels - Measured body weight within 50 to 130 kg - Signed informed consent
Exclusion Criteria
- Acute symptomatic pulmonary embolism (PE) requiring systemic or catheter-directed thrombolytic therapy, catheter-directed mechanical thrombectomy, or surgical embolectomy - Active bleeding or high risk for bleeding (at the discretion of the investigator) - Recent (<3 months) ischemic stroke, myocardial infarction, intracranial hemorrhage, or major surgery or severe trauma (at the discretion of the investigator) - Active cancer, i.e., locally active, regionally invasive or metastatic and/or anticancer therapy within the last 6 months, except basal cell or squamous cell carcinoma - Therapeutic-dose anticoagulants for > 72 hours before randomization, or current use of vitamin K antagonists - Planned or current use of the following medications: -- Any antiplatelet therapy, except acetylsalicylic acid (ASA) ≤100 mg/day -- Antifibrinolytic drugs -- Therapeutic antibodies - Male participants with women of childbearing potential (WOCBP) partners unwilling to use highly effective contraception from start of study intervention until end of study.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine Reggio Emilia, Italy, 42122 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione Bologna, Italy, 40138 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche Roma, Italy, 00168 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi Varese, Italy, 21100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso Treviso, Italy, 31100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico Padova, Italy, 35128 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department Castelfranco Veneto, Italy, <unknown> | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie Dresden, Germany, 01307 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin Berlin, Germany, 12203 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie Muenchen, Germany, 80336 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie Muenster, Germany, 48149 Münster | Status Suspended | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Groeninge - Campus Kennedylaan Kortrijk, Belgium, 8500 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman Liege, Belgium, 4000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB) Leuven, Belgium, 3000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling Antwerp, Belgium, 2650 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department Genk, Belgium, 3600 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Sint-Maarten Mechelen, Belgium, 2800 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations McGill University Health Centre – Glen Site Montreal, Canada, H4A 3J1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil Toulouse, France, 31059 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Louis Mourier - Colombes Cedex Colombes, France, 92701 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC) Strasbourg, France, 67091 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche Brest, France, 29609 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Groupe Hospitalier Sud - Amiens AMIENS cedex1, France, 80054 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Europeen Georges-Pompidou (HEGP) Paris, France, 75908 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied Clermont Ferrand, France, 63003 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Sainte Musse Toulon, France, 83100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon La Tronche, France, 38700 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord Saint Etienne, France, 42000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Hospital | Internal Medicine - Hematology Department Dordrecht, Netherlands, 3318 AT | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Isala Zwolle, Netherlands, 8025AB | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center) Leiden, Netherlands, 2300 RC | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Radboud University Medical Center | Afdeling Interne Geneeskunde Nijmegen, Netherlands, 6500 HB | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maastricht University Medical Center | School for Cardiovascular Diseases - Biochemie Maastricht, Netherlands, 6229 HX | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rijnstate | Arnhem - Internal Medicine Department - Vascular Research Arnhem, Netherlands, 6815 AD | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zuyderland Medical Centre | Internal Medicine Department Geleen, Netherlands, 6162 BG | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche Rozzano, Italy, 20089 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Imelda - Vascular Surgery Dept Bonheiden, Belgium, 2820 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie Bad Krozingen, Germany, 79189 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Mlada Boleslav - interni oddeleni Mlada Boleslav, Czech Republic, 293 01 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations II. interni klinika - klinika kardiologie a angiologie 1. lekarske fakulty a Vseobecne fakultni nemocnice Praha 2, Czech Republic, 128 08 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations II. interni klinika, Cevni ambulance (angiologicka ambulance), Fakultni nemocnice u sv. Anny v Brne Brno, Czech Republic, 602 00 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace Krnov, Czech Republic, 794 01 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 100 34 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace Znojmo, Czech Republic, 669 02 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Roudnice nad Labem - interni oddeleni Roudnice nad Labem, Czech Republic, 41301 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stredoslovenský ústav srdcových a cievnych chorôb, a.s. - Oddelenie angiológie Banská Bystrica, Slovakia, 974 01 | Status Suspended | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospitale, s.r.o. - Interné oddelenie Šahy, Slovakia, 936 01 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department Spišská Nová Ves, Slovakia, 052 01 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kardiocentrum AGEL a.s. - Angiologické oddelenie Košice, Slovakia, 040 15 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia Košice, Slovakia, 040 01 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnicná a.s. - Interné oddelenie Malacky, Slovakia, 901 22 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Penta Hospitals | Rimavska Sobota Hospital - Internal Medicine Department Rimavská Sobota, Slovakia, 979 01 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario de Navarra- Medicina Interna Pamplona, Spain, 31008 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Infanta Sofia-Medicina Interna San Sebastian de los Reyes, Spain, 28702 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario la Paz-Medicina Interna Madrid, Spain, 28046 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari De Girona Doctor Josep Trueta-Medicina Interna Girona, Spain, 17007 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krajská zdravotní, Masarykova nemocnice Ústí nad Labem - Kardiologická jednotka intenzivní péce Usti nad Labem, Czech Republic, 400 11 | Status Suspended | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vojenska nemocnice Brno - kardiologicke interni oddeleni Brno, Czech Republic, 615 00 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT National Heart Hospital EAD Sofia, Bulgaria, 1309 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD Sofia, Bulgaria, 1431 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hospital For Active Treatment 'Sveta Ekaterina' EAD Sofia, Bulgaria, 1431 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Institute Ministry of Interior Sofia, Bulgaria, 1606 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Specialized Hospital For Active Cardiology Treatment Medica Kor EAD Ruse, Bulgaria, 7013 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hospital For Active Treatment Kanev AD Ruse, Bulgaria, 7002 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department Veliko Tarnovo, Bulgaria, 5000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont - I. sz. Belgyogyaszati Klinika Pecs, Hungary, 7624 | Status Suspended | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat Székesfehérvár, Hungary, 8000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz - Kardiovaszkularis es Belgyogyaszati centrum Miskolc, Hungary, 3526 | Status Suspended | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz Békéscsaba, Hungary, 5600 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály Kaposvár, Hungary, 7400 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia Kistarcsa, Hungary, 2143 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika Szeged, Hungary, 6725 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia Budapest, Hungary, 1088 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ankara Bilkent Sehir Hastanesi Bilkent ankara, Turkey, 6800 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erciyes Universitesi Tip Fakultesi Kayseri, Turkey, 38039 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit Istanbul, Turkey, 34846 | Status Suspended | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi Istanbul, Turkey, 34744 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Izmir Sehir Hastanesi Izmir, Turkey, 35540 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bagcilar Egitim ve Arastirma Hastanesi Istanbul, Turkey, 34200 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Larissa - Department of Vascular surgery of University of Thessaly Larissa, Greece, 41110 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital Attikon - 1st Department of Vascular surgery University of Athens Athens, Greece, 124 62 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery Efkarpia, Greece, 564 29 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty Ioannina, Greece, 455 00 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital Of Athens G Gennimatas- Department of Vascular Surgery Athens, Greece, 115 27 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General University Hospital Of Patras- Department of Vascular Surgery Patras, Greece, 265 04 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Penta Hospitals | Nemocnica Bory - Department of Internal Medicine Bratislava, Slovakia, 841 03 | Status Suspended | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of BAY 3018250 in patients with symptomatic proximal deep vein thrombosis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
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 burdenTimeframe: 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.Timeframe: up to Day 15
Secondary Outcome
- Ratio to baseline of clot burden, as assessed by quantitative ultrasoundTimeframe: 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).Timeframe: 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.Timeframe: at Day 7, Day 30 and Day 90
- Number of participants with recurrent venous thromboembolismTimeframe: up to Day 90
Additional Information
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