Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI) (RIVER-PCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01442038
First received: September 22, 2011
Last updated: June 6, 2016
Last verified: June 2016
Results First Received: February 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
Angina Pectoris
Interventions: Drug: Ranolazine
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at study sites in the United States, Canada, Europe, Russia, and Israel. The first participant was screened on 03 November 2011. The last study visit occurred on 09 February 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2734 participants were screened.

Reporting Groups
  Description
Ranolazine Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
Placebo Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)

Participant Flow:   Overall Study
    Ranolazine   Placebo
STARTED   1332   1319 
COMPLETED   1029   1040 
NOT COMPLETED   303   279 
Death                35                29 
Investigator-Initiated Early Closure                44                43 
Participant Withdrew Consent                137                102 
Lost to Follow-up                37                51 
Adverse Event                26                15 
Protocol Deviation                9                20 
Investigator's Discretion                13                16 
Study Terminated By Sponsor                2                3 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Safety Analysis Set: participant who were randomized and received at least one dose of study drug

Reporting Groups
  Description
Ranolazine Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
Placebo Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
Total Total of all reporting groups

Baseline Measures
   Ranolazine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1322   1297   2619 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.4  (10.51)   63.4  (10.06)   63.4  (10.29) 
Age, Customized 
[Units: Participants]
     
< 65 Years   714   719   1433 
65-74 Years   402   383   785 
≥ 75 Years   206   195   401 
Gender 
[Units: Participants]
     
Female   276   260   536 
Male   1046   1037   2083 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   0   3   3 
Asian   16   10   26 
Black or African American   49   43   92 
Native Hawaiian or Pacific Islander   2   1   3 
White   1203   1196   2399 
Other   29   28   57 
Not Permitted   23   16   39 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   72   64   136 
Not Hispanic or Latino   1219   1208   2427 
Not Reported   28   24   52 
Unknown   3   1   4 
Region of Enrollment 
[Units: Participants]
     
Russian Federation   154   168   322 
United States   499   466   965 
United Kingdom   16   17   33 
Spain   80   87   167 
Canada   80   85   165 
Austria   12   15   27 
Czech Republic   31   44   75 
Netherlands   13   13   26 
Sweden   19   25   44 
Belgium   20   21   41 
Poland   203   172   375 
Italy   28   33   61 
Israel   111   109   220 
France   22   15   37 
Germany   34   27   61 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization   [ Time Frame: Baseline through end of study (average 90 weeks) ]

2.  Secondary:   Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death   [ Time Frame: Baseline through end of study (average 90 weeks) ]

3.  Secondary:   Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death   [ Time Frame: Baseline through end of study (average 90 weeks) ]

4.  Secondary:   Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction   [ Time Frame: Baseline through end of study (average 90 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
e-mail: ClinicalTrialDisclosures@gilead.com


Publications of Results:
Other Publications:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01442038     History of Changes
Other Study ID Numbers: GS-US-259-0116
2011-002507-15 ( EudraCT Number )
Study First Received: September 22, 2011
Results First Received: February 9, 2016
Last Updated: June 6, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Poland: The Central Register of Clinical Trials
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee