Antithrombotic Agents Clinical Trial
— RATED RegistryOfficial title:
Registry of Patient With Antithrombotic Agents Admitted to an Emergency
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 ...).
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | February 2024 |
| Est. primary completion date | January 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age over 18 years - Patient under antithrombotic agent who came in the emergency unit for any reason Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | look for risk factors of bleeding events | 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) | at day 1 | |
| Primary | look for risk factors of major bleeding events | 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) | at day 1 | |
| Secondary | Number of death | - The number of death (with all cause of mortality) during the hospitalisation of the patient regarding the discharge letter of the patient | at day 1 | |
| Secondary | Adjudicated symptomatic recurrence of thromboembolic events | at day 1 | ||
| Secondary | number of symptomatic thromboembolic events | - the number of symptomatic thromboembolic events during the hospitalisation of the patient regarding the discharge letter of the patient | at day 1 | |
| Secondary | number of cardiovascular events | - the number of cardiovascular events during the hospitalisation of the patient regarding the discharge letter of the patient | at day 1 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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