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Stroke Prevention and Rhythm Interventions in Atrial Fibrillation (SPRINT-AF)

This study is not yet open for participant recruitment.
Verified December 2012 by Canadian Cardiovascular Research Network
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Canadian Cardiovascular Research Network
ClinicalTrials.gov Identifier:
NCT01733160
First received: November 2, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SPRINT-AF: Stroke Prevention and Rhythm Interventions in Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Canadian Cardiovascular Research Network:

Primary Outcome Measures:
  • To determine how Canadian physicians assess stroke risk in adults with atrial fibrillation and make therapeutic decisions around anticoagulation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the adequacy of anticoagulation in treated patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To understand how new oral anticoagulants are incorporated into clinical practice [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To assess quality of life in patients with AF [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To evaluate how physicians select between rate and rhythm control options for AF [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To evaluate regional differences in care [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To compare management strategies between primary care physicians and cardiovascular specialists [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples (plasma and serum, up to 10ml per patient) may be collected for the evaluation of circulating biomarkers as they relate to atrial fibrillation. The collection of these samples will be subject to the availability of additional funding. Furthermore, the exact biomarker(s) profile is yet to be defined; however, all such sub-studies and/or analyses will be undertaken only after appropriate ethics approval. Notwithstanding this we will not use these samples for genetic analysis of any nature.


Estimated Enrollment: 3000
Study Start Date: January 2013
Estimated Study Completion Date: July 2024
Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care and specialist clinics

Criteria

Inclusion Criteria:

  • Documented atrial fibrillation (ECG, rhythm strip, device interrogation) within the past 12 months; 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733160

Contacts
Contact: Michelle R Tsigoulis, RN 905-453-8885 ext 228 mtsigoulis@ccrnmd.com
Contact: Mahesh P Kajil, MBBS 905-453-8885 ext 214 mkajil@hotmail.com

Locations
Canada, Ontario
CCRN
Brampton, Ontario, Canada, L6Z 4N5
Sponsors and Collaborators
Canadian Cardiovascular Research Network
Bayer
Investigators
Principal Investigator: Milan K Gupta, MD Canadian Cardiovascular Research Network
Principal Investigator: Subodh Verma, MD Canadian Cardiovascular Research Network
  More Information

Publications:
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, Rydén 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. Epub 2011 Feb 14.

Responsible Party: Canadian Cardiovascular Research Network
ClinicalTrials.gov Identifier: NCT01733160     History of Changes
Other Study ID Numbers: SPRINT-AF 18-10-2012
Study First Received: November 2, 2012
Last Updated: December 3, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Canadian Cardiovascular Research Network:
Atrial Fibrillation
Stroke
Anticoagulants

Additional relevant MeSH terms:
Atrial Fibrillation
Cardiovascular Diseases
Stroke
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013