What Treatment for Patients With Phlebitis or Pulmonary Embolism ? (AntiCoagChoice)

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

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.

Study Overview

• Status: Unknown
• Conditions: Venous Thrombosis or Pulmonary Embolism
• Intervention / Treatment: Other: anticoagulation choice

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: cecile ferragu; Phone Number: 02 99 28 25 55; Email: cecile.ferragu@chu-rennes.fr
• Study Contact Backup: Name: direction de la recherche clinique; Phone Number: 02 99 28 25 55; Email: drc@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35000
    • Recruiting
    • Rennes University Hospital
    • Contact: Guillaume Mahe; Email: guillaume.mahe@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age in France (via the vascular doctors of the French Society of Vascular Médicine).

Description

Inclusion Criteria:

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

No Exclusion Criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with venous thromboembolic disease; Patients with deep vein thrombosis, superficial or muscular vein thrombosis, pulmonary embolism, over 18 years of age.	Other: anticoagulation choice; Type of anticoagulant chosen by the patient (oral or injectable).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: SFMV (French Society of Vascular Medicine)
• Investigators: Principal Investigator: Guillaume Mahe, Rennes University Hospital

Publications and helpful links

General Publications

• Laneelle D, Le Brun C, Mauger C, Guillaumat J, Le Pabic E, Omarjee L, Mahe G; SFMV VTE Study Group. Patient Characteristics and Preferences Regarding Anticoagulant Treatment in Venous Thromboembolic Disease. Front Cardiovasc Med. 2021 Jun 21;8:675969. doi: 10.3389/fcvm.2021.675969. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Anticipated): February 12, 2021
• Study Completion (Anticipated): February 12, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Deep Vein Thrombosis; pulmonary embolism; Anticoagulant; Patient Compliance; Preference; Venous Thrombosis; Superficial Vein Thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: 35RC18_3002_AntiCoagChoice

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No