Global Anticoagulant Registry in the Field (GARFIELD-AF)
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|ClinicalTrials.gov Identifier: NCT01090362|
Recruitment Status : Unknown
Verified December 2014 by Thrombosis Research Institute.
Recruitment status was: Recruiting
First Posted : March 19, 2010
Last Update Posted : December 5, 2014
|Condition or disease|
Using data from more than 1000 randomly selected centres across 35 countries, representing all possible care settings, the registry will help to characterize real-life anticoagulant treatment patterns and outcomes, including rates of stroke and bleeding complications, as well as provide data on other important issues, such as physicians' compliance with guidelines and patients' adherence to therapy. This is particularly timely as standard practice moves away from vitamin K antagonist (VKA)-dominated therapy and towards a new era of novel oral anticoagulants (OACs), i.e. direct Factor Xa inhibitors and direct thrombin inhibitors.
To ensure a dataset that truly reflects current practice, the investigators are requested to prospectively enrol all newly diagnosed patients with non-valvular AF who have at least one additional investigator-determined risk factor for stroke. Patients are consecutively recruited into one of five cohorts and followed up for at least 2 years.
With 3 cohorts complete and 36,000 enrolled GARFIELD-AF continues to recruit patients and, in conjunction with other registries and non-interventional studies, will be the source of further informative and useful data in the coming years. The findings will serve to increase our understanding of the management of patients with AF and improve our practice for their benefit.
|Study Type :||Observational|
|Estimated Enrollment :||55000 participants|
|Official Title:||Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Cohort complete with 5,088 retrospective patients and 5,499 prospective patients recruited from 19 countries.
Cohort completed with 11,351 patients enrolled from 30 countries
Cohort 3 completed with 11,139 patients enrolled globally from 32 countries
Cohort 4 ongoing (commenced Aug 2014) with 2600 patients recruited to date and a target of 11,000 patients enrolled from 35 countries.
Final cohort to commence August 2015 with a target of 11,000 patients enrolled. Last patient enrolled to complete 2 years of follow-up.
- Death [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
- Systemic embolism [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
- Heart failure [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
- Acute coronary syndromes [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
- Therapy persistence [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
- Patient satisfaction with oral anticoagulant treatment [ Time Frame: 4, 8, 12 and 24 months ]
- Bleeding Events [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
- Strokes (Haemorrhagic and thrombotic) [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090362
|Contact: Gloria Kayanifirstname.lastname@example.org|
|Contact: Oscar Howieemail@example.com|
|Study Director:||Ajay K Kakkar, MD||Thrombosis Research Institute, London, UK|