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Status unknownNCT02706080RATED RegistryUpdated Sep 5, 2017

Registry of Patient With Antithrombotic Agents Admitted to an Emergency Department

An observational study in Antithrombotic Agents, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by University Hospital, Clermont-Ferrand · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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 ...).

Read the 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.

02

Conditions studied

  • Antithrombotic Agents

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Keywords

  • Antithrombotic agents
  • VKA
  • Direct Oral Anticoagulant
  • Antiplatelet
  • Bleeding
  • Emergency
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In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's planned enrollment of 10 is below the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Antithrombotic agents

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Otheremergency
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: at day 1

  2. 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)

    Time frame: at day 1

Secondary outcomes

  1. 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

    Time frame: at day 1

  2. Adjudicated symptomatic recurrence of thromboembolic events

    Time frame: at day 1

  3. number of symptomatic thromboembolic events

    - the number of symptomatic thromboembolic events during the hospitalisation of the patient regarding the discharge letter of the patient

    Time frame: at day 1

  4. number of cardiovascular events

    - the number of cardiovascular events during the hospitalisation of the patient regarding the discharge letter of the patient

    Time frame: at day 1

07

Study locations

1 of 1 sites recruiting
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
    Recruiting
08

References and documents

Publications

  • Moustafa F, Malhomme R, Pereira B, Barres A, Saint-Denis J, Dutheil F, Batisse M, Schmidt J. Assessment of the Impact of L-Thyroxine Therapy on Bleeding Risk in Patients Receiving Vitamin K Antagonists. Clin Drug Investig. 2017 Oct;37(10):929-936. doi: 10.1007/s40261-017-0545-9. PubMed 28612237 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02706080
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Mar 11, 2016
Start date
Jan 2014
Primary completion
Jan 2024 (estimated)
Completion
Feb 2024 (estimated)
Last update
Sep 5, 2017

Study contacts

Patrick LACARIN
Contact
vpaquet@chu-clermontferrand.fr
04 73 75 11 95
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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