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Anticoagulant-induced Bleeding clinical trials

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NCT ID: NCT06194617 Recruiting - Pulmonary Embolism Clinical Trials

Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients

Start date: April 1, 2021
Phase:
Study type: Observational

There's no unified recommendation in clinical practice regarding adjusting dosages for different patient types, especially when adverse events occur. While rivaroxaban typically doesn't require coagulation monitoring, in elderly patients, particularly those with multiple medications, finding appropriate lab indicators becomes crucial to gauge its anticoagulant effect. This aids in evaluating precise rivaroxaban dosing for the elderly, balancing bleeding risks and recurrence. Clinical pharmacological studies suggest that drug pharmacokinetics and pharmacodynamics in different populations can guide dosage optimization. Hence, this study aims to provide a basis for optimizing dosing regimens in high-risk elderly patients in China by exploring pharmacokinetic and pharmacodynamic indicators in clinical practice.

NCT ID: NCT06168838 Recruiting - Clinical trials for Intracranial Hemorrhages

Anticoagulant-associated Intracranial Hemorrhage

AAIHINNN
Start date: August 9, 2023
Phase:
Study type: Observational

Oral anticoagulant therapy, including factors Xa and 2a inhibitors has become more popular in recent years due to its efficacy and convenience in preventing thrombotic events and reducing the risk for stroke in patients with rosk factors (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism). These drugs have replaced traditional therapies such as warfarin, which requires frequent dose adjustments and control blood samples. Warfarin also has a higher risk of bleeding events. Many patients with atrial fibrillation, particularly old patients and those with comorbidities may have trouble achieving the dose and control requirements for warfarin therapy. On the other hand, Direct Oral Anticoagulant therapies do not require a close monitorization and have a lower risk of bleeding events, which makes them a more attractive option for many patients. There is solid evidence behind the efficacy and safety of Direct Oral Anticoagulant therapies. Multiple clinical trials have demonstrated that Factor Xa inhibitors like rivaroxaban and apixaban are as effective as warfarin in preventing blood clots and reducing stroke risk in patients living with atrial fibrillation. These challenges remark the need for new research that can improve our comprehension about the risk of bleeding associated to anticoagulant therapies and develop novel and more effective strategies for minimizing this risk. Hence, an observational analysis about anticoagulant-associated intracranial hemorrhage may help identifying its incidence and prevalence, as well as treatment patterns and identifying any patient with risk factors linked to these events. This information can be used to improve patient outcomes and guide future research. Work Hypothesis: The majority of intracranial hemorrhage events are associated with heparin, low molecular weight heparin and warfarin instead of Factor Xa inhibitors or direct thrombin inhibitors. Nevertheless, the growing use in recent years of factor Xa inhibitors can increase the number of this therapy related bleeding events.

NCT ID: NCT05801068 Recruiting - Atrial Fibrillation Clinical Trials

Perioperative Management of Factor Xa Inhibitors

PERIXA
Start date: August 4, 2020
Phase: N/A
Study type: Interventional

This study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at risk of minor bleeding in actual clinical settings

NCT ID: NCT05290857 Recruiting - Clinical trials for GastroIntestinal Bleeding

Anticoagulation After GI Bleeding Pilot Study and Registry

PANTHER-GI
Start date: March 31, 2022
Phase: N/A
Study type: Interventional

PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.

NCT ID: NCT05079295 Recruiting - Clinical trials for Chronic Subdural Hematoma

Management of Anticoagulants and Antithrombotics in Patients With CSDH

THERCA
Start date: February 20, 2021
Phase:
Study type: Observational

Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.

NCT ID: NCT04997265 Recruiting - Thromboembolism Clinical Trials

Strategies for Anticoagulation During Venovenous ECMO

SAFE-ECMO
Start date: May 12, 2022
Phase: N/A
Study type: Interventional

Moderate intensity titrated dose anticoagulation has been used in patients receiving extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic mechanical complications. As technology has improved, however, the incidence of thromboembolic events has decreased, leading to re-evaluation of the risks of anticoagulation, particularly during venovenous (V-V) ECMO. Recent data suggest that bleeding complications during V-V ECMO may be more strongly associated with mortality than thromboembolic complications, and case series have suggested that V-V ECMO can be safely performed without moderate or high intensity anticoagulation. At present, there is significant variability between institutions in the approach to anticoagulation during V-V ECMO. A definitive randomized controlled trial is needed to compare the effects of a low intensity fixed dose anticoagulation (low intensity) versus moderate intensity titrated dose anticoagulation (moderate intensity) on clinical outcomes during V-V ECMO. Before such a trial can be conducted, however, additional data are needed to inform the feasibility of the future trial.

NCT ID: NCT04291287 Recruiting - Atrial Fibrillation Clinical Trials

Triple or Dual Antithrombotic Therapy After PCI (TRIDUAL-PCI) Coronary Intervention in Patients With Non-valvular Atrial Fibrillation. Real-world Italian Multicenter Registry (TRIDUAL-PCI)

TRIDUAL-PCI
Start date: January 25, 2020
Phase:
Study type: Observational

Aim of this study is to describe clinical and procedural characteristics of real-world population initiated on triple antithrombotic therapy (double antiplatelet therapy+anticoagulant) or double antithrombotic therapy (single antiplatelet therapy+anticoagulant) after percutaneous coronary intervention (PCI). Investigator's driven trial, retrospective (2015-2019), multicenter Italian registry. Baseline clinical characteristics as well as procedural details will be collected retrospectively. Follow-up data (minimum 6 months and maximum 5 years follow-up) will focus on combined rates of stent thrombosis and myocardial infarction (primary endpoint).

NCT ID: NCT04263038 Recruiting - Clinical trials for Cardiovascular Diseases

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

SAFE-SSPE
Start date: May 15, 2020
Phase: Phase 4
Study type: Interventional

The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.

NCT ID: NCT03186729 Recruiting - Atrial Fibrillation Clinical Trials

Study of Antithrombotic Treatment After IntraCerebral Haemorrhage

STATICH
Start date: July 1, 2018
Phase: Phase 4
Study type: Interventional

The study evaluates the effects of antithrombotic drugs (anticoagulant drugs or antiplatelet drugs) for prevention of ischaemic events in patients With recent intracerebral haemorrhage.

NCT ID: NCT03124030 Recruiting - Dental Diseases Clinical Trials

Intra- and Post- Operative Bleeding After Simple Dental Extraction in Direct Oral Anticoagulant Therapy

NOADB
Start date: August 2, 2016
Phase: N/A
Study type: Observational

Direct Oral Anticoagulants were recently approved for medical treatment of several condition such as, non valvular atrial fibrillation, deep venous thrombosis, and others, substituting sometimes the conventional oral anticoagulants. The aim of the present study is to observe the possible difference in intra-operative and post-operative bleeding events for single dental extraction.