Abstract

The AFFIRM Study is a two-arm clinical trial of high risk patients with documented atrial fibrillation and a high risk of recurrence, morbid events, and death. The treatment will be randomized to rhythm control and anticoagulation, or rate control and anticoagulation. Consenting adults with a qualifiying episode of atrial fibrillation within 30 days and considered to be at significant risk for stroke will be categorized as single episode (in which case sinus rhythm will be restored prior to randomization) or recurrent episodes (2 or more episodes in the past 6 months). The primary endpoint of the trial is total morbidity. Secondary endpoints include stroke, intracranial hemorrhage, disabling anoxic encephalopathy, major non-CNS hemorrhage, cardiac arrest, cost of therapy, quality of life, and functional status.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-39
Application #
6441938
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106

  Publications

Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1
Osman, Ahmed Fageer; Thomas, Biju; Singh, Nakul et al. (2017) Impact of Infant-Polysomnography Studies on Discharge Management and Outcomes: A 5 Year Experience from a Tertiary Care Unit. J Neonatal Biol 6:
Tita, Alan T N; Lai, Yinglei; Landon, Mark B et al. (2017) Predictive Characteristics of Elevated 1-Hour Glucose Challenge Test Results for Gestational Diabetes. Am J Perinatol 34:1464-1469
Grams, Morgan E; Yang, Wei; Rebholz, Casey M et al. (2017) Risks of Adverse Events in Advanced CKD: The Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis 70:337-346

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