A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:1/7/2017
Start Date:July 2014
End Date:June 2016

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Placebo-Controlled Parallel Arm Study to Evaluate the Safety, Tolerability, and Effect on Atrial Fibrillation Burden of BMS-919373 in Patients With Paroxysmal Atrial Fibrillation

The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation
(AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with
paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg
QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD,
respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will
reduce AF burden as compared to baseline relative to placebo.

Primary Purpose: Protocol designed to assess, by the use of long term non-invasive
beat-to-beat monitoring with the SEEQ Mobile Cardiac Telemetry (MCT) system, the effect of
BMS-919373 on the percent change from baseline relative to placebo of atrial fibrillation
burden in subjects with paroxysmal atrial fibrillation.

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Signed informed consent

- Paroxysmal Atrial Fibrillation (pAF) with available documentation of AF and reporting
symptoms within 6 months prior to screening

- Able to tolerate withdrawal of antiarrhythmic therapy (rhythm control)

- Echocardiographically measured left ventricular ejection fraction (LVEF)
≥40%,measured within 12 months of enrollment

- Echocardiographically measured left atrial (LA) diameter ≤ 5.0 cm, measured within 12
months of enrollment

Exclusion Criteria:

- Women of childbearing potential

- AFB < 3% or > 70%, during both screening periods independently

- Permanent or persistent Atrial Fibrillation

- Cardioversion within 3 months of study drug administration

- Stroke within 12 months of study drug administration

- TIA within 12 months of study drug administration

- Heart failure of NYHA class III or greater (symptoms of heart failure at rest or with
minimal exertion)

- Heart failure of NYHA class II (symptoms of heart failure with routine levels of
exertion)with ejection fraction <40% as measured by echocardiography at any time
within 12 months of study enrollment (i.e. additional ejection fraction measurements
≥ 40% over this period will not counter this exclusion)

- Valvular heart disease (including any valvular insufficiency or stenosis greater
than"mild")

- Ablation within 3 months of study enrollment
We found this trial at
20
sites
6804 South Canton
Tulsa, Oklahoma 74136
918-524-5205
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Phone: 203-419-4407
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Alexandria, Louisiana 71301
Phone: 318-473-4613
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Anaheim, California 92801
Phone: 714-239-1112
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anaheim, California 92801
Phone: 909-635-4799
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anderson, Indiana 46011
?
mi
from
Anderson, IN
Click here to add this to my saved trials
Austin, Texas 78758
Phone: 512-458-9410
?
mi
from
Austin, TX
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
Phone: 717-441-1724
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
Columbus, Georgia 31904
Phone: 706-321-0495
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Cooper City, Florida 33024
?
mi
from
Cooper City, FL
Click here to add this to my saved trials
Costa Mesa, California 92626
Phone: 714-668-1500
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Edmonton, Alberta
?
mi
from
Edmonton,
Click here to add this to my saved trials
Gainesville, Florida 32605
Phone: 352-244-0208
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Lake Worth, Florida 33462
Phone: 561-966-8815
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
Largo, Florida 33770
Phone: 727-489-5415
?
mi
from
Largo, FL
Click here to add this to my saved trials
Layton, Utah 84041
Phone: 801-791-2206
?
mi
from
Layton, UT
Click here to add this to my saved trials
Long Beach, California 90822
Phone: 562-826-5933
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Moreno Valley, California 92553
Phone: 951-247-3080
?
mi
from
Moreno Valley, CA
Click here to add this to my saved trials
Overland Park, Kansas 66209
Phone: 913-253-3053
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Tullahoma, Tennessee 37388
Phone: 931-461-2663
?
mi
from
Tullahoma, TN
Click here to add this to my saved trials