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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590979
Recruitment Status : Terminated (The study was terminated due to slow rate of accrual resulting in a sample size.)
First Posted : May 3, 2012
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Soad Bekheit, Northwell Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (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
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 27 27
Completed 27 27
Not Completed 0 0
Arm/Group Title Ranolazine Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
65.7  (11.7) 62.9  (11.1) 64.3  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
5
  18.5%
6
  22.2%
11
  20.4%
Male
22
  81.5%
21
  77.8%
43
  79.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 54 participants
27 27 54
1.Primary Outcome
Title Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients
Hide Description [Not Specified]
Time Frame 3 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Fifty-four patients were randomized with a mean follow-up of 25 months and none were lost to follow-up. The study was terminated due to slow rate of accrual resulting in a sample size of 27 ranolazine and 27 placebo.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 27 27
Measure Type: Count of Participants
Unit of Measure: Participants
5
  18.5%
8
  29.6%
Time Frame Post op (days 1-6); hospital discharge; Post -op follow up (2-3 weeks); Follow up call (day 28).
Adverse Event Reporting Description Patients were given a medication log post discharge to note when medication was taken and to note any other comments related to how they were feeling.
 
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Ranolazine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ranolazine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/27 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ranolazine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/27 (14.81%)      3/27 (11.11%)    
Gastrointestinal disorders     
Constipation   0/27 (0.00%)  0 2/27 (7.41%)  2
Nausea   3/27 (11.11%)  3 1/27 (3.70%)  1
General disorders     
Dizziness   1/27 (3.70%)  1 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
Due to insufficient accrual rate the study was stopped before the recruitment total was met. Thus, a major limitation is small sample size.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Soad Bekheit, MD
Organization: Staten Island University Hospital, Northwell Health
Phone: 718-226-6629
EMail: msills@northwell.edu
Layout table for additonal information
Responsible Party: Soad Bekheit, Northwell Health
ClinicalTrials.gov Identifier: NCT01590979    
Other Study ID Numbers: Bekheit-Ranolazine
First Submitted: April 27, 2012
First Posted: May 3, 2012
Results First Submitted: September 8, 2016
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017