Stroke Prevention and Rhythm Interventions in Atrial Fibrillation

NCT01733160 | Completed

• 1 other identifier: SPRINT-AF 18-10-2012
• Study Type: observational
• Target: 2,499
• Locations: 1 country
• Sites: 1

Brief Summary

This observational registry will characterize contemporary stroke prevention in Canadian adults with atrial fibrillation, and provide clarity in understanding physician preferences for the various oral anticoagulants available in the Canadian marketplace. This study will determine the patient profiles of those selected for the various therapies available in Canada and provide an understanding of the factors involved in drug selection and management.

Conditions

Cardiovascular Diseases

Keywords

Atrial Fibrillation; Stroke; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• To determine how Canadian physicians assess stroke risk in adults with atrial fibrillation and make therapeutic decisions around anticoagulation

  1 year

Secondary Outcomes (6)

• To assess the adequacy of anticoagulation in treated patients

  1 year

• To understand how new oral anticoagulants are incorporated into clinical practice

  1 year

• To assess quality of life in patients with AF

  1 year

• To evaluate how physicians select between rate and rhythm control options for AF

  1 year

• To evaluate regional differences in care

  1 year

Eligibility Criteria

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

Study Population

Primary care and specialist clinics

You may qualify if:

• Documented atrial fibrillation (ECG, rhythm strip, device interrogation, discussion of an AF diagnosis in the participant's clinical report) within the past 10 years; paroxysmal, persistent or permanent
• Age \> 18 years
• Most recent visit for a patient having had a clinical visit with Investigator occurring within the past one year

You may not qualify if:

• Valvular AF (hemodynamically significant valvular heart disease including rheumatic mitral valve disease or at least moderate aortic valve stenosis)
• Life expectancy \< 12 months
• Active malignancy (treated or untreated)
• Indication for systemic anticoagulation independent of atrial fibrillation (venous thromboembolism, mechanical heart valve)
• Prior participation in any OAC randomized clinical trial

Sponsors & Collaborators

• Canadian Collaborative Research Network: lead
• Bayer: collaborator

Study Sites (1)

CCRN

Brampton, Ontario, L6Z 4N5, Canada

Location

Related Publications (4)

• Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30.

  PMID: 19717844 BACKGROUND

• Wann LS, Curtis AB, Ellenbogen KA, Estes NA 3rd, Ezekowitz MD, Jackman WM, January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG, Tracy CM, Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Kay GN, Le Heuzey JY, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann LS, Jacobs AK, Anderson JL, Albert N, Creager MA, Ettinger SM, Guyton RA, Halperin JL, Hochman JS, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on Dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2011 Mar 15;123(10):1144-50. doi: 10.1161/CIR.0b013e31820f14c0. Epub 2011 Feb 14. No abstract available.

  PMID: 21321155 BACKGROUND

• Dorian P, Guerra PG, Kerr CR, O'Donnell SS, Crystal E, Gillis AM, Mitchell LB, Roy D, Skanes AC, Rose MS, Wyse DG. Validation of a new simple scale to measure symptoms in atrial fibrillation: the Canadian Cardiovascular Society Severity in Atrial Fibrillation scale. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):218-24. doi: 10.1161/CIRCEP.108.812347. Epub 2009 Mar 31.

  PMID: 19808471 BACKGROUND

• Cairns JA, Connolly S, McMurtry S, Stephenson M, Talajic M; CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society atrial fibrillation guidelines 2010: prevention of stroke and systemic thromboembolism in atrial fibrillation and flutter. Can J Cardiol. 2011 Jan-Feb;27(1):74-90. doi: 10.1016/j.cjca.2010.11.007.

  PMID: 21329865 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Milan K Gupta, MD

  Canadian Collaborative Research Network

  PRINCIPAL INVESTIGATOR

• Andrew Ha, MD

  Canadian Collaborative Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 26, 2012
• Study Start: November 1, 2013
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CA (1)