Trial record 1 of 1 for:    River-PCI
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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
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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
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
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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.
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  
Number of Participants  
[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
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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
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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
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  More Information
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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