Ranolazine Cardioprotection in PCI

This study has been terminated.
(Sponsor terminated study due to lack of enrollment)
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Harvey Hahn, Kettering Health Network
ClinicalTrials.gov Identifier:
NCT01767987
First received: November 28, 2012
Last updated: October 20, 2015
Last verified: October 2015
Results First Received: September 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Acute Coronary Syndrome
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ranolazine

Oral treatment Intervention: Drug: Ranolazine 1000 mg

Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI

Placebo

Oral treatment Intervention: Drug: Placebo

Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI


Participant Flow:   Overall Study
    Ranolazine     Placebo  
STARTED     4     2  
COMPLETED     0     1  
NOT COMPLETED     4     1  
Physician Decision                 4                 1  



  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.
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Reporting Groups
  Description
Ranolazine

Oral treatment Intervention: Drug: Ranolazine 1000 mg

Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI

Placebo

Oral treatment Intervention: Drug: Placebo

Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI

Total Total of all reporting groups

Baseline Measures
    Ranolazine     Placebo     Total  
Number of Participants  
[units: participants]
  4     2     6  
Age  
[units: years]
Mean (Full Range)
  61.5   (51 to 66)     67.5   (65 to 70)     63.5   (51 to 70)  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     0     2  
>=65 years     2     2     4  
Gender  
[units: participants]
     
Female     3     1     4  
Male     1     1     2  
Region of Enrollment  
[units: participants]
     
United States     4     2     6  



  Outcome Measures
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1.  Primary:   Troponin   [ Time Frame: 8-10 hrs post PCI ]

2.  Primary:   CK-MB   [ Time Frame: 8-10 hrs post PCI ]

3.  Secondary:   TIMI Flow Rate (Grade)   [ Time Frame: TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure. ]

4.  Secondary:   Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab   [ Time Frame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire ]

5.  Secondary:   Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI   [ Time Frame: Following completion of PCI through hospital discharge ]

6.  Secondary:   Left Ventricular End Diastolic Pressure (LVEDP)   [ Time Frame: During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire ]

7.  Secondary:   Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest   [ Time Frame: At discharge or within 1 days, whichever comes first ]

8.  Secondary:   Death, MI, Revascularization, CHF   [ Time Frame: 1-4 weeks post PCI ]

9.  Secondary:   Successful PCI   [ Time Frame: At discharge or within 1 days, whichever comes first ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Suzanne Coleman, PhD
Organization: Kettering Health Network
phone: 937-395-8390
e-mail: suzanne.coleman@khnetwork.org



Responsible Party: Harvey Hahn, Kettering Health Network
ClinicalTrials.gov Identifier: NCT01767987     History of Changes
Other Study ID Numbers: ISR IN-US-259-0139
Study First Received: November 28, 2012
Results First Received: September 9, 2014
Last Updated: October 20, 2015
Health Authority: United States: Institutional Review Board