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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

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'.

Condition or disease Intervention/treatment Phase
Microvascular Angina Drug: Ranolazine Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ranolazine and Microvascular Angina by PET in the Emergency Department (RAMP-ED)
Study Start Date : April 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Ranolazine

Arm Intervention/treatment
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).
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

Placebo Comparator: Placebo Control
Subjects will take placebo pill twice daily for 4 weeks.
Drug: Placebo



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052011


Locations
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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Gilead Sciences
Investigators
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Principal Investigator: Basmah Safdar, MD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02052011     History of Changes
Other Study ID Numbers: 1312013144
First Posted: January 31, 2014    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017
Last Verified: February 2017
Keywords provided by Yale University:
Chest Pain
Microvascular Angina
Ranolazine
Emergency department
PET
Additional relevant MeSH terms:
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Angina Pectoris
Emergencies
Disease Attributes
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action