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Trial record 79 of 182 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

Tracking Information
First Submitted Date  ICMJE January 30, 2014
First Posted Date  ICMJE January 31, 2014
Results First Submitted Date  ICMJE November 22, 2016
Results First Posted Date  ICMJE May 16, 2017
Last Update Posted Date May 16, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
Coronary Flow Reserve [ Time Frame: 4 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
Coronary Flow Reserve [ Time Frame: 4 weeks ]
Compare changes in coronary flow reserve as measured by cardiac PET in patients receiving Ranolazine versus control
Change History Complete list of historical versions of study NCT02052011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
SAQ Scores [ Time Frame: 4 weeks ]
Determine if Ranolazine changes SAQ scores in association with changes in CFR versus controls.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 30, 2014)
Return Visits [ Time Frame: 4 weeks ]
Compare the composite rates of return visits (office, emergency department and hospitalization) for ches pain within 4 weeks of enrollment between patients with and without Ranolazine.
 
Descriptive Information
Brief Title  ICMJE Ranolazine and Microvascular Angina by PET in the Emergency Department
Official Title  ICMJE Ranolazine and Microvascular Angina by PET in the Emergency Department (RAMP-ED)
Brief Summary The purpose of this study is to determine the effectiveness of Ranolazine for the treatment chest pain from disease of small vessels of the heart also known as 'microvascular angina'.
Detailed Description

The Yale Chest Pain Center (CPC) is a unique clinical lab that provides an integrated interdisciplinary research team, access to high volume of chest pain patients largely free of coronary disease (93%) as well state of the art diagnostics including cardiac PET and a sophisticated system for serum processing and banking facilities. The CPC cohort represents a unique population with unrecognized microvascular disease and is often only accessible through the ED. We propose a one-year pilot study to understand the mechanisms of angina relief by Ranolazine (n=20) in patients with microvessel disease in the ED population as compared to controls (n=10) at baseline and at 1-month. In addition, changes in pain scores and function as measured by Seattle Angina Questionnaire (SAQ), recidivism and costs will be measured and correlated with changes in coronary flow reserve (CFR). Serum samples will be obtained and banked for future marker analysis as intermediate surrogates of outcomes.

Primary aim: To compare changes in coronary flow reserve as measured by cardiac PET in patients receiving Ranolazine versus controls.

Secondary aim: To determine if Ranolazine changes Seattle Angina Questionnaire (SAQ) scores in association with changes in Coronary Flow Reserve (CFR) versus controls.

Exploratory aim: To compare composite rate of return visits (office, emergency department and hospitalization) for chest pain within 4-weeks of enrollment between patients with and without Ranolazine.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Microvascular Angina
Intervention  ICMJE
  • Drug: Ranolazine
    Subjects will take the extended-release Ranolazine for a total of 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).
    Other Name: Ranexa
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Intervention Group
    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).
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo Control
    Subjects will take placebo pill twice daily for 4 weeks.
    Intervention: Drug: Placebo
Publications * Safdar B, D'Onofrio G, Dziura J, Russell RR, Johnson C, Sinusas AJ. Ranolazine and Microvascular Angina by PET in the Emergency Department: Results From a Pilot Randomized Controlled Trial. Clin Ther. 2017 Jan;39(1):55-63. doi: 10.1016/j.clinthera.2016.12.002. Epub 2017 Jan 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2016)
31
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2014)
30
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients admitted to the Yale ED CPC
  • ≥ 30 years age
  • chest pain or angina equivalent as their chief complaint within 24 hours of enrollment
  • Coronary Flow Reserve(CFR) <2.5 on PET scan in the ED.

Exclusion Criteria:

  • Acute coronary syndrome
  • Prior evidence of obstructive heart disease (history of Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery Bypass Grafting (CABG) or calcium score > 10 on PET scan)
  • Resting blood pressure of systolic >180/110 mm Hg or <100/40
  • known cardiomyopathy or heart failure
  • currently on dialysis
  • creatinine clearance <30 ml/min
  • liver cirrhosis
  • significant aortic stenosis (murmur on exam)
  • active use of cocaine or amphetamine
  • current use of potent CYP3A4 inducers or inhibitors (such as ketoconazole, clarithromycin, HIV protease inhibitors)
  • baseline QTc > 580 msec
  • use of drugs that prolong QTc (Haldol, erythromycin)
  • pregnancy
  • inability to read or understand English
  • suffering from a condition that precludes interview (i.e. cognitive or communication impairment).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02052011
Other Study ID Numbers  ICMJE 1312013144
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Principal Investigator: Basmah Safdar, MD Yale University
PRS Account Yale University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP