Evaluating of CREATIF an Anti-coagulation Clinic

NCT01349530 | Completed

• 2 other identifiers: K0809052010-A00213-36
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

Main objective: To evaluate the impact of CREATIF (an anticoagulation clinic in Ile de France) on monitoring and management of patients treated with VKAs compared with usual primary care. Study hypothesis: The investigators suppose that patients will have a better quality of anticoagulation when they are managed by CREATIF than by their usual General Physicians (GP)

Conditions

Vitamin K Antagonist

Keywords

Usual medical care; Anticoagulation by VKAs: COUMADINE® & PREVISCAN®; Anticoagulation clinic care, CREATIF

Outcome Measures

Primary Outcomes (1)

• Proportion of time in the therapeutic anticoagulation range ± 0.5 INR unit.

  INR goal according following areas: • 2 to 3 (target 2.5) / 2.5 to 3.5 (Target 3) / 3 to 4.5 (target 3.75). Anticoagulation quality was measured using percentage of time in therapeutic INR range (%TTR). Absolute difference of 10% of TTR, taking into account the published data showing a percentage of time in therapeutic INR range of about 50% with a standard deviation of around 23% in usual medical care.

  at 13 months

Secondary Outcomes (3)

• Reduce accidents and iatrogenic cost, which may be related to VKA (major haemorrhage and thrombosis).

  at 13 months

• Number of INR prescribed by the GP during usual medical care compared with the number of INR prescribed under Monitoring by the CREATIF

  at 13 months

• Score of education one month before and after the formation session

  at 13 months

Study Arms (2)

Anticoagulation clinic care

EXPERIMENTAL

Monitoring by CREATIF

Other: Evaluation of CREATIF

Usual care

ACTIVE COMPARATOR

Monitoring by GP.

Other: Evaluating of usual care

Interventions

Evaluating of usual care OTHER

RESEARCH IN CURRENT CARE

Usual care

Evaluation of CREATIF OTHER

RESEARCH IN CURRENT CARE

Anticoagulation clinic care

Eligibility Criteria

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

You may qualify if:

• General Physicians in the city and have agreed to participate in the study by signing an undertaking.
• Patient has not expressed its opposition to the use of data as part of research
• Patient man or woman whose age is ≥ 18 years
• Patients whose condition requires treatment by VKAs PREVISCAN® or COUMADINE® with an INR target in areas following: 2 to 3 (target 2.5), 2.5 to 3.5 (target 3) or 3 to 4.5 (target 3.75)
• Patient for which the oral anticoagulant treatment had been prescribed and administered for at least 6 months
• Patient insured under Social Security

You may not qualify if:

• Patient treated by SINTROM®

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (2)

Service d'hématologie - Hôpital Lariboisière

Paris, 75010, France

Location

50, rue de la Justice

Paris, 75020, France

Location

Study Officials

• Ludovic DROUET, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 6, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 4, 2017

Record last verified: 2016-12

Locations

FR (2)