Clinical trials: Anticoagulants and Bleeding Disorders
Gastrointestinal Bleeding, Cardiovascular Complication
Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY
This observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (Vitamin K antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban).
- Conditions
- Gastrointestinal Bleeding, Cardiovascular Complication, Anticoagulants; Circulating, Hemorrhagic Disorder, Gastrointestinal Endoscopy
- Trial name
- NCT03669068
- Testing
- Gastrointestinal endoscopy
- Where
- Spain
- Volunteers
- 1,602 people
- Sponsor
- Hospital Universitario Ramon y Cajal
Venous Thromboembolism, Major Bleed
Direct Oral Anticoagulants and Venous Thromboembolism
The purpose of this study is to determine whether use of direct oral anticoagulants (DOACs) is associated with an increased risk of major bleeding compared to warfarin use, for the treatment of venous thromboembolism (VTE).
- Trial name
- NCT02833987
- Testing
- Apixaban (ATC B01AF02), Dabigatran (ATC B01AE07), Rivaroxaban (ATC B01AF01)
- Where
- Canada
- Volunteers
- 59,525 people
- Sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
Anticoagulants and Bleeding Disorders, Surgery
Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin
The main objective of this study is to determine the time interval following the last treatment dose of enoxaparin at which the amount of anti-Xa level activity is reliably less than 0.2 international unit per milliliter (IU/mL)…
- Conditions
- Anticoagulants and Bleeding Disorders, Surgery, Regional Anesthesia Morbidity
- Trial name
- NCT03296033
- Testing
- Enoxaparin
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Wake Forest University Health Sciences
Cirrhosis, Esophageal and Gastric Varices
Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study designed to evaluate the efficacy and safety of apixaban in combination with carvedilol versus placebo with carvedilol in preventing…
- Conditions
- Cirrhosis, Esophageal and Gastric Varices, Ascites, Hepatic Encephalopathy
- Trial name
- APIXABAN-PK (NCT07521332)
- Testing
- Apixaban, Carvedilol
- Where
- Pakistan
- Volunteers
- 220 people
- Sponsor
- Asian Institute Of Medical Sciences
Covid19, Pneumonia
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection
Viral infections provoke the systemic inflammatory response and cause an imbalance between the procoagulant and anticoagulant homeostatic mechanisms.
- Conditions
- Covid19, Pneumonia, Coagulation Disorder, Pulmonary Embolism
- Trial name
- NCT04508439
- Testing
- Enoxaparin
- Where
- Mexico
- Volunteers
- 130 people
- Sponsor
- Hospital Regional de Alta especialidad de Ixtapaluca
Atrial Fibrillation
A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)
The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.
- Trial name
- EQUAL-AF (NCT05044533)
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation, Atrial Flutter
Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation
The overall goal of this study is to evaluate the effectiveness of a previously developed storytelling intervention on anticoagulation (AC) initiation/persistence in African American and Black patients with atrial…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Adherence, Medication, Anticoagulants and Bleeding Disorders
- Trial name
- NCT05997914
- Testing
- Storytelling Intervention
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of Massachusetts, Worcester
Arterial Occlusion, Cardiovascular Diseases
Comparing TR Band to Statseal in Conjunction With TR Band II
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma
- Trial name
- Statseal II (NCT04046952)
- Testing
- Statseal with TR Band, TR band only
- Where
- United States
- Volunteers
- 443 people
- Sponsor
- VA Long Beach Healthcare System
Mitral Regurgitation
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant
Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups).
- Trial name
- STAR-TEER Ⅱ (NCT07007143)
- Testing
- Experimental: Aspirin monotherapy, Active Comparator: Aspirin+Clopidogrel
- Where
- China
- Volunteers
- 1,032 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Ischemic Stroke
Intracerebral Hemorrhage Due to Oral Anticoagulants: Prediction of the Risk by Magnetic Resonance
The purpose of this study is to determine whether Magnetic Resonance Imaging may predict the risk of Intracerebral Hemorrhage for patients with ischemic stroke who receive indefinite oral anticoagulation
- Trial name
- HERO (NCT02238470)
- Testing
- oral anticoagulants
- Where
- 30 sites in Italy, Spain
- Volunteers
- 1,000 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lung Transplantation, Extracorporeal Membrane Oxygenation (ECMO)
Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation
The aim of this observational pilot study is to evaluate the effectiveness and safety of low-molecular-weight heparin (LMWH) compared to unfractionated heparin (UFH) as anticoagulation in perioperative ECMO during bilateral lung…
- Conditions
- Lung Transplantation, Extracorporeal Membrane Oxygenation (ECMO), Anticoagulants and Bleeding Disorders
- Trial name
- LUX-ET-LT (NCT06868823)
- Where
- Czechia
- Volunteers
- 40 people
- Sponsor
- University Hospital, Motol
Stable Angina, Unstable Angina
COMBO-Stent in Patients on Chronic Anticoagulant Therapy (COSTA) COSTA-Bleed and COSTA-Outcome Trials
Prospective, multi-centre, randomized, open-label, parallel comparisons to evaluate the incidence of bleedings (COSTA-Bleed) and the incidence of ischemic and bleeding events (COSTA-Outcome) following a therapy with the abluminal…
- Conditions
- Stable Angina, Unstable Angina, STEMI, NSTEMI
- Trial name
- COSTA (NCT02723981)
- Testing
- COMBO-Stent, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran, Any drug eluting stent oder bare metal sent
- Where
- 10 sites in Germany
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
Cerebrovascular Stroke, Intracranial Hemorrhages
Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban
This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore…
- Conditions
- Cerebrovascular Stroke, Intracranial Hemorrhages, Anticoagulant, Matrix Metalloproteinases
- Trial name
- NCT03772457
- Testing
- Rivaroxaban
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Significant Bleeding Risk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex®…
- Trial name
- NCT02740335
- Testing
- Octaplex, Beriplex P/N (Kcentra)
- Where
- 86 sites in United States, Belarus and 9 more
- Volunteers
- 208 people
- Sponsor
- Octapharma
Foot Ankle Injuries, Anticoagulants and Bleeding Disorders
A Prospective Study in Chinese Patients With Lower Extremity Ankle Fracture of Oral Anticoagulants to Prevent Venous Thromboembolism (VTE)
Deep vein Thrombosis (Deep Venous Thrombosis, DVT) and Pulmonary Embolism, Pulmonary Embolism, PE) both collectively known as Venous thromboembolism (VTE) (Venous Thrombus Embolism, VTE), is a common clinical disease, and…
- Conditions
- Foot Ankle Injuries, Anticoagulants and Bleeding Disorders, Venous Thromboembolism
- Trial name
- NCT04128254
- Testing
- Apixaban Oral Tablet
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Venous Thromboembolism, Atrial Fibrillation
Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants
The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel questions among clinicians confronted with the…
- Trial name
- GIHP-NACO (NCT02185027)
- Testing
- complications and compliance with GIHP recommendations
- Where
- 41 sites in Belgium, France
- Volunteers
- 1,166 people
- Sponsor
- University Hospital, Grenoble
Ischaemic Stroke
Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN (ELAN): an International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial
When to start anticoagulation in patients with an acute ischaemic stroke and atrial fibrillation (AF) is a relevant unanswered question in clinical practice.
- Trial name
- ELAN (NCT03148457)
- Testing
- Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®), Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)
- Where
- 98 sites in Austria, Belgium and 13 more
- Volunteers
- 2,013 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Anticoagulants and Bleeding Disorders
MAC Project, Monitoring of AntiCoagulant Therapies (MAC)
MAC Project is a prospective cohort, multicenter, observational, no-profit study aimed to prospectively collect reliable real-life clinical information in unselected VTE or NVAF patients treated with any DOAC, during a…
- Trial name
- MAC (NCT04329390)
- Testing
- Anticoagulant drugs
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- Quovadis Associazione
Adenovirus, Anesthesia
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved.
- Conditions
- Adenovirus, Anesthesia, Anxiety, Anxiolysis
- Trial name
- PTN_POPS (NCT01431326)
- Testing
- The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 3,520 people
- Sponsor
- Daniel Benjamin
Thrombosis, Bleeding
Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)
Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy.
- Trial name
- NCT02872649
- Testing
- Dabigatran, Phenprocoumon
- Where
- Austria
- Volunteers
- 16 people
- Sponsor
- Daniel Zimpfer, MD