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Trial record 79 of 180 for:    ERYTHROMYCIN

Ranolazine and Microvascular Angina by PET in the Emergency Department (RAMP-ED)

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ClinicalTrials.gov Identifier: NCT02052011
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Microvascular Angina
Interventions Drug: Ranolazine
Drug: Placebo
Enrollment 31
Recruitment Details This study was conducted from June, 2014-November, 2015 at the Yale New Haven Hospital Chest Pain Center, an ED observation unit that treats low-moderate cardiac risk patients.
Pre-assignment Details  
Arm/Group Title Intervention Group Placebo Control
Hide Arm/Group Description Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin). Subjects will take placebo pill twice daily for 4 weeks.
Period Title: Overall Study
Started 21 10
Completed 17 8
Not Completed 4 2
Reason Not Completed
Lost to Follow-up             3             0
Withdrawal by Subject             1             2
Arm/Group Title Intervention Group Placebo Control Total
Hide Arm/Group Description Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin). Subjects will take placebo pill twice daily for 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 21 10 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 10 participants 31 participants
50  (7) 50  (5) 50  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 10 participants 31 participants
Female
13
  61.9%
9
  90.0%
22
  71.0%
Male
8
  38.1%
1
  10.0%
9
  29.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 10 participants 31 participants
Hispanic or Latino
3
  14.3%
5
  50.0%
8
  25.8%
Not Hispanic or Latino
18
  85.7%
5
  50.0%
23
  74.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 10 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  33.3%
2
  20.0%
9
  29.0%
White
14
  66.7%
8
  80.0%
22
  71.0%
More than one race NA [1]  NA [1]  NA [2] 
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
not asked
[2]
Total not calculated because data are not available (NA) in one or more arms.
TIMI Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 10 participants 31 participants
0-1
16
  76.2%
9
  90.0%
25
  80.6%
2-3
5
  23.8%
1
  10.0%
6
  19.4%
4-7
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Thrombolysis in Myocardial Infarction (TIMI) Score measures mortality risk for unstable angina and myocardial infarction. The score ranges 0-7 with lower score indicating lower risk. 0-2 is considered low risk for acute coronary syndrome.
1.Primary Outcome
Title Coronary Flow Reserve
Hide Description Compare changes in coronary flow reserve as measured by cardiac PET(Positron Emission Tomography) in patients receiving Ranolazine versus control. This is the ratio between stress and rest myocardial blood flow in response to stress.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Placebo Control
Hide Arm/Group Description:
Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
Subjects will take placebo pill twice daily for 4 weeks.
Overall Number of Participants Analyzed 17 8
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline CFR 1.6  (0.3) 1.6  (0.3)
Post-Treatment CFR 1.9  (0.4) 1.6  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.08 to 0.62
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Placebo Control
Hide Arm/Group Description Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin). Subjects will take placebo pill twice daily for 4 weeks.
All-Cause Mortality
Intervention Group Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention Group Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   3/21 (14.29%)   0/10 (0.00%) 
General disorders     
Dizziness   3/21 (14.29%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
Small sample size with higher than expected dropout rates.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Basmah Safdar
Organization: Yale School of Medicine
Phone: 2037853453
EMail: basmah.safdar@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02052011     History of Changes
Other Study ID Numbers: 1312013144
First Submitted: January 30, 2014
First Posted: January 31, 2014
Results First Submitted: November 22, 2016
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017