NCT02052011

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'.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 16, 2017

Completed
Last Updated

May 16, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

January 30, 2014

Results QC Date

November 22, 2016

Last Update Submit

April 10, 2017

Conditions

Microvascular Angina

Keywords

Chest PainMicrovascular AnginaRanolazineEmergency departmentPET

Outcome Measures

Primary Outcomes (1)

  • Coronary Flow Reserve

    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.

    4 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Placebo Control

PLACEBO COMPARATOR

Subjects will take placebo pill twice daily for 4 weeks.

Drug: Placebo

Interventions

RanolazineDRUG

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).

Also known as: Ranexa
Intervention Group
PlaceboDRUG
Placebo Control

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 28081848DERIVED

MeSH Terms

Conditions

Microvascular AnginaChest PainEmergencies

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Small sample size with higher than expected dropout rates.

Results Point of Contact

Title
Dr. Basmah Safdar
Organization
Yale School of Medicine
basmah.safdar@yale.edu
2037853453

Study Officials

  • Basmah Safdar, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

January 31, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

May 16, 2017

Results First Posted

May 16, 2017

Record last verified: 2017-02

Locations

US(1)