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Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation

This study has been terminated.
(The study was terminated due to slow rate of accrual resulting in a sample size.)
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Soad Bekheit, Northwell Health
ClinicalTrials.gov Identifier:
NCT01590979
First received: April 27, 2012
Last updated: February 1, 2017
Last verified: February 2017
Results First Received: September 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Prevention
Conditions: Atrial Fibrillation New Onset
Hemorrhage
Prolonged QTc Interval
Ventricular Tachycardia
Medical Care; Complications, Late Effect of Complications
Interventions: Drug: Ranolazine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ranolazine

The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.

Ranolazine: 1000mg, two times a day, 12 hour intervals

Placebo

Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)

Placebo: two times a day, 12 hour intervals


Participant Flow:   Overall Study
    Ranolazine   Placebo
STARTED   27   27 
COMPLETED   27   27 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ranolazine

The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.

Ranolazine: 1000mg, two times a day, 12 hour intervals

Placebo

Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)

Placebo: two times a day, 12 hour intervals

Total Total of all reporting groups

Baseline Measures
   Ranolazine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   27   54 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12  44.4%      12  44.4%      24  44.4% 
>=65 years      15  55.6%      15  55.6%      30  55.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.7  (11.7)   62.9  (11.1)   64.3  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  18.5%      6  22.2%      11  20.4% 
Male      22  81.5%      21  77.8%      43  79.6% 
Region of Enrollment 
[Units: Participants]
     
United States   27   27   54 


  Outcome Measures

1.  Primary:   Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients   [ Time Frame: 3 weeks after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to insufficient accrual rate the study was stopped before the recruitment total was met. Thus, a major limitation is small sample size.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Soad Bekheit, MD
Organization: Staten Island University Hospital, Northwell Health
phone: 718-226-6629
e-mail: msills@northwell.edu



Responsible Party: Soad Bekheit, Northwell Health
ClinicalTrials.gov Identifier: NCT01590979     History of Changes
Other Study ID Numbers: Bekheit-Ranolazine
Study First Received: April 27, 2012
Results First Received: September 8, 2016
Last Updated: February 1, 2017