Anticoagulant Clinics and Vitamin K Antagonists

NCT00966290 | Completed Phase 4 DMC

• 2 other identifiers: 0200301PHRC 2002
• Study Type: interventional
• Target: 1,006
• Locations: 1 country
• Sites: 7

Brief Summary

Background: Whether the management of vitamin K antagonists (VKA) therapy by general practitioners with the collaboration of anticoagulation clinics (ACC) provides better clinical outcomes than that accomplished by general practitioners alone (usual care \[UC\] management) is not clear. Objectives: To compare ACC-based shared-care management with UC management of VKA therapy with respect to clinical events. Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at least three months. The primary study outcome is a composite of confirmed symptomatic thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All outcomes are reviewed by a central, independent adjudication committee.

Conditions

Blood Coagulation Disorders

Keywords

anticoagulants; management; anticoagulation clinics; randomized comparison

Outcome Measures

Primary Outcomes (1)

• Each patient is contacted by standardized telephone calls every three months to determine whether he/she has experienced any thromboembolic or major bleeding complication, and to identify any interruptions in VKA treatment

  Patients are followed up for the duration of VKA treatment until 12 months or plus three days after treatment discontinuation

Secondary Outcomes (1)

• Quality of anticoagulation control evaluated in all patients with at least two INR measurements and assessed by determining (1) the percentage of INR within the target range, (2) the percentage of time during which the INR is within the target range

  Patients are followed up for the duration of VKA treatment until 12 months or plus three days after treatment discontinuation.

Study Arms (2)

ACC group

EXPERIMENTAL

Anticoagulant clinic-based shared-care group

Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)

UC group

ACTIVE COMPARATOR

Usual care group

Drug: Anticoagulant (warfarin, acenocoumarol, fluindione)

Interventions

Anticoagulant (warfarin, acenocoumarol, fluindione) DRUG

Anticoagulant clinic based shared-care group

Also known as: Patients whose anticoagulation is managed by the general practitioner in collaboration with anticoagulant clinic

ACC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• inpatients and outpatients who are starting a course of VKA therapy scheduled to last for at least three months

You may not qualify if:

• life expectancy of less than three months
• contraindication to anticoagulant therapy because of bleeding risk
• refusal of his/her general practitioner to participate in the study
• no general practitioner likelihood of poor follow-up or poor compliance (e.g., patients unable to care for themselves, lacking adequate home support or unwilling to comply with the treatment care plan)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (7)

University Hospital

Brest, 29609, France

Location

Louis Pasteur Hospital

Dole, 39100, France

Location

University Hospital

Lille, 59037, France

Location

Dupuytren University Hospital

Limoges, 87042, France

Location

Bellevue University Hospital

Saint-Etienne, 42055, France

Location

University Hospital

Strasbourg, 67091, France

Location

Rangueil University Hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Interventions

Anticoagulants; Warfarin; Acenocoumarol; fluindione

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Henri Boccalon, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• Alessandra BURA-RIVIERE, MD

  University Hospital, Toulouse

  STUDY DIRECTOR

• Patrick Mismetti, MD

  University Hospital Saint-Etienne

  STUDY DIRECTOR

• Bernard Boneu, MD

  University Hospital, Toulouse

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 26, 2009
• Study Start: February 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 26, 2009

Record last verified: 2009-08

Locations

FR (7)