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Registry of Patient With Antithrombotic Agents Admitted to an Emergency Department (RATED Registry)

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ClinicalTrials.gov Identifier: NCT02706080
Recruitment Status : Recruiting
First Posted : March 11, 2016
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Antithrombotics with antiplatelet agents, vitamin K antagonist (VKA), heparin and related substances, and new oral anticoagulants are prescribed for arterial diseases, especially in secondary prevention of embolic disease in carrier patients of heart valves and in patients with fibrillation atrial, and venous diseases, in prevention and treatment.

The prescription of these treatments is increasing especially in older patients associated with many comorbidities. Today, an estimated number of 900 000 patients under anti-vitamin K in France, and more than 1.5 million for patients on antiplatelet agents.

Venous thromboembolism (VTE) is common in the general population with an annual incidence of 10-18 cases per 10 000. The most severe form of VTE is represented by pulmonary embolism with a third of cases. Even if a large literature allows for high grade recommendations on many areas, there is still some gray areas regarding the long-term outcomes, the early evolution and tolerance of treatment, including long-term recurrence, the incidence of embolic sequelae with post-embolic pulmonary hypertension and association with other cardiovascular arterial accident (acute Coronary Syndrome, Stroke, arterial disease of the Lower Extremities ...).

The major risk of these antithrombotic is bleeding both in terms of morbidity mortality. Despite this risk, little study focuses on the exact epidemiology of bleeding associated with the use of antithrombotic. If the frequency of hemorrhagic stroke is low, some populations particularly at risk of bleeding represent the majority of serious bleeding events under VKA or anti-platelet. However, the VKA and antiplatelet agents are the first providers of hemorrhagic serious side effects drugs when looking at all national and international studies on the iatrogenic with in topped gastrointestinal bleeding and intracerebral hemorrhage (mortality of about 10 to 15%).

Moreover the recent arrival of new oral anticoagulants (Apixaban rivaroxaban, dabigatran ...) should profoundly change the management of venous thromboembolism and cardioembolic event. Because of their risk-benefit, simplicity and convenience of their prescription, the number of patients treated with these new anticoagulants were to rise rapidly. In addition, many patients deemed too "fragile" to be treated with VKA, should be treated with these treatments. These new anti-Xa and anti-IIa anticoagulants already marketed or about to be. They have the advantage over VKA: an oral way, their pharmacokinetic characteristics, absence of biological monitoring, chemical synthesis .... If it is not possible today to give the advantage to one or the other of these molecules, the choice will be directed by their pharmacokinetic characteristics, their half life, their method of disposal but also by patients co-morbidities. Although biological tests are currently available for the monitoring of these products, therapeutic solutions for severe bleeding does not exist: there is indeed no antidote for now, though the issue is finding a balance between increased therapeutic benefit and bleeding risk optimization. But hemorrhagic stroke is the most serious complications of oral anticoagulant therapy, with substantial documentation for these events occurring under VKA but little data on those occurring with the new oral anticoagulants (Apixaban rivaroxaban, dabigatran ...).


Condition or disease Intervention/treatment
Antithrombotic Agents Other: emergency

Detailed Description:
We propose to realize a single-center prospective registry of patient under Antithrombotic agent who came to the emergency unit for any reason.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Registry of Patient With Antithrombotic Agents Admitted to an Emergency
Study Start Date : January 2014
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
Antithrombotic agents
We propose to realize a single-center prospective registry of patient under Antithrombotic agent who came to the emergency unit for any reason.
Other: emergency



Primary Outcome Measures :
  1. look for risk factors of bleeding events [ Time Frame: at day 1 ]
    The bleeding events was noted when the patient arrive in the emergency unit. For the major bleeding event, it was bleeding that was fatal or overt bleeding with a drop in haemoglobin level of at least 20 g/L or requiring transfusion of at least 2 units packed blood cells, or haemorrhage into a critical anatomical site (intracranial, gastrointestinal)

  2. look for risk factors of major bleeding events [ Time Frame: at day 1 ]
    The bleeding events was noted when the patient arrive in the emergency unit. For the major bleeding event, it was bleeding that was fatal or overt bleeding with a drop in haemoglobin level of at least 20 g/L or requiring transfusion of at least 2 units packed blood cells, or haemorrhage into a critical anatomical site (intracranial, gastrointestinal)


Secondary Outcome Measures :
  1. Number of death [ Time Frame: at day 1 ]
    - The number of death (with all cause of mortality) during the hospitalisation of the patient regarding the discharge letter of the patient

  2. Adjudicated symptomatic recurrence of thromboembolic events [ Time Frame: at day 1 ]
  3. number of symptomatic thromboembolic events [ Time Frame: at day 1 ]
    - the number of symptomatic thromboembolic events during the hospitalisation of the patient regarding the discharge letter of the patient

  4. number of cardiovascular events [ Time Frame: at day 1 ]
    - the number of cardiovascular events during the hospitalisation of the patient regarding the discharge letter of the patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Antithrombotic agents
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Patient under antithrombotic agent who came in the emergency unit for any reason

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706080


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 vpaquet@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Farès MOUSTAFA         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02706080     History of Changes
Other Study ID Numbers: CHU-0257
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Keywords provided by University Hospital, Clermont-Ferrand:
Antithrombotic agents
VKA
Direct Oral Anticoagulant
Antiplatelet
Bleeding
Emergency
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action