What Treatment for Patients With Phlebitis or Pulmonary Embolism ?

Venous Thrombosis or Pulmonary Embolism Clinical Trial

— AntiCoagChoice  

Official title:

Patients' Choice in Terms of Anticoagulant Therapy in Venous Thrombo- Embolism Disease. AntiCoagChoice Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03889457
• Other study ID #: 35RC18_3002_AntiCoagChoice
• Status: Recruiting
• Start date: February 12, 2019
• Est. completion date: February 12, 2021

Study information

• Verified date: February 2019
• Source: Rennes University Hospital
• Contact: Cecile Ferragu
• Phone: 02 99 28 25 55
• Email: cecile.ferragu[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the "anticoagchoice" study is to analyze the preferences of people suffering from phlebitis, in terms of anticoagulant, to improve adherence to these treatments, to adapt the medical prescriptions.

Description:

Venous thromboembolism (VTE) is the third leading cause of cardiovascular death, with an increase in annual incidence with age. With the advent of direct oral anticoagulants, the management of deep vein thrombosis and pulmonary embolism has evolved in recent years and these treatments are widely prescribed. There are studies comparing the different anticoagulant treatments used in venous thrombosis, which show no inferiority of treatment (injectable or oral) compared to others. Drug delivery modalities have been shown to affect adherence, and thus treatment efficacy. It seems fundamental to focus on patients' drug preferences in VTE to ensure the best possible compliance. These preferences seem to depend on the personal history of each patient. In addition, no studies have been conducted on patient preferences for anticoagulant therapy for VTE: this is the goal of the "anticoagchoice" study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age.

No Exclusion Criteria

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis
• Venous Thrombosis or Pulmonary Embolism

Intervention

Other:
• anticoagulation choice
Type of anticoagulant chosen by the patient (oral or injectable).

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	SFMV (French Society of Vascular Medicine)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to analyze patient treatment preferences in venous thromboembolic disease.	The primary outcome: To compare the proportion of patients choosing oral anticoagulation vs patients choosing injectable route.	the time required for a consultation: 30 minutes
Secondary	compare patients choosing oral anticoagulation vs patients choosing an injectable route	proportions of patients choosing an oral anticoagulation vs. patients choosing an injectable pathway depending on the duration of treatment (3 months, 6 months or more),	the time required for a consultation: 30 minutes
Secondary	compare patients choosing oral anticoagulation vs patients choosing an injectable route	Identify factors influencing these choices, depending on the characteristics of the patient (history, age, gender, social environment, personal experience).	the time required for a consultation: 30 minutes