Chronic Stable AnginaPhase 4SARANCT01558830
Safety of Amiodarone and Ranolazine Together in Patients With Angina
A Phase 4 study testing ranolazine in people with Chronic Stable Angina and Coronary Artery Disease, run by Cardiovascular Consultants of Nevada at 3 sites in United States.
Trial summary
Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Stable Angina, Coronary Artery Disease, Atrial Fibrillation
- What is being tested?
- ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic cardiac disease
- chronic anginal symptoms
- on amiodarone therapy for other cardiac conditions
Who cannot join
- pregnant
- non-English speaking
- unstable angina
- baseline electrocardiogram (EKG) corrected QT (QTc)>490ms
- severe thyroid dysfunction
- heart block without a pacer system
- liver disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Cardiovascular Consultants of Nevada
Henderson, Nevada, 89052
- Recruiting
Cardiovascular Consultants of Nevada
Las Vegas, Nevada, 89144
- Recruiting
Cardiovascular Consultants of Nevada
Las Vegas, Nevada, 89196
About this study
Official title: Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina
Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. The investigators have proposed a study to determine the safety of ranolazine in patients with chronic stable angina who also take amiodarone. And are conducting a prospective single-center randomized single-blinded placebo controlled trial to run out of our large cardiology practice setting at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia episodes on serial holter monitor and other serially acquired recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data) over a three month trial period.
- Conditions
- Chronic Stable Angina, Coronary Artery Disease, Atrial Fibrillation, Ventricular Tachycardia
- Being tested
- ranolazine, placebo
- Keywords
- amiodarone, ranolazine, safety, arrhythmia
- Medical subject headings
- Angina, Stable, Coronary Artery Disease, Atrial Fibrillation, Tachycardia, Ventricular, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranolazineDrug
Also called Ranexa
ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina
placeboDrug
one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | one pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy Receives: Drug: placebo |
| Ranolazine | Active comparator | 500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms Receives: Drug: ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventricular arrhythmia
primary outcome is the burden of ventricular arrhythmias measured on serial holter monitor recordings, stress test recordings, pacemaker or implantable defibrillator (ICD) recordings if available, at baseline and serially to trial completion.
Measured: 3 months
Secondary outcomes (5)
atrial arrhythmia burden
burden of atrial arrhythmias will be measured on serial holter monitor recordings
Measured: 3 months
Electrocardiogram (EKG) corrected QT (QTc) interval measurement
The electrocardiogram (EKG) corrected QT (QTc) interval be quantitated at baseline and serially to trial completion
Measured: over the 3 month trial
hospitalization
Hospitalization rates, if any, will be serially quantitated to trial completion
Measured: 3 months
syncope hospitalization
syncope hospitalization rate quantitation to trial completion
Measured: 3 months
liver function assay
serum liver function testing will be conducted at baseline and serially to trial completion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Consultants of Nevada
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Erik J SIrulnick, MD, Principal investigator, Cardiovascular Consultants of Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558830
- Sponsor's protocol ID
- IN-US-259-0121
- Acronym
- SARA
- Status last verified
- Mar 2012
- First submitted
- 18 Mar 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Amiodarone and Ranolazine Together in Patients With Stable Angina
- ClinicalTrials.gov ID
- NCT01558830
- Acronym / sponsor ID
- SARA / IN-US-259-0121
- Conditions
- Chronic Stable Angina, Coronary Artery Disease, Atrial Fibrillation, Ventricular Tachycardia
- Keywords
- amiodarone, ranolazine, safety, arrhythmia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cardiovascular Consultants of NevadaUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. The investigators have proposed a study to determine the safety of ranolazine in patients with chronic stable angina who also take amiodarone. And are conducting a prospective single-center randomized single-blinded placebo controlled trial to run out of our large cardiology practice setting at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia episodes on serial holter monitor and other serially acquired recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data) over a three month trial period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Drug: placeboone pill twice daily, uptitrated to two pills twice daily to mirror ranolazine prescription strategy |
| Ranolazine | Active comparator | Drug: ranolazine500 mg twice daily, titrated to 1000 mg twice daily if needed for relief of anginal symptoms |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ischemic cardiac disease
- chronic anginal symptoms
- on amiodarone therapy for other cardiac conditions
Key exclusion criteria (7 listed)
- pregnant
- non-English speaking
- unstable angina
- baseline electrocardiogram (EKG) corrected QT (QTc)>490ms
- severe thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranolazineAlso: Ranexaranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina | Drug | Ranolazine |
| placeboone pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy | Drug | sugar pill |
Primary outcome
ventricular arrhythmia
Time frame: 3 months
primary outcome is the burden of ventricular arrhythmias measured on serial holter monitor recordings, stress test recordings, pacemaker or implantable defibrillator (ICD) recordings if available, at baseline and serially to trial completion.
5 secondary outcomes
atrial arrhythmia burden
Time frame: 3 months
Electrocardiogram (EKG) corrected QT (QTc) interval measurement
Time frame: over the 3 month trial
hospitalization
Time frame: 3 months
syncope hospitalization
Time frame: 3 months
liver function assay
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik J SIrulnick, MD principal investigator
Cardiovascular Consultants of Nevada
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ranolazine in people with Chronic Stable Angina and Coronary Artery Disease, run by Cardiovascular Consultants of Nevada at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik J Sirulnick, MD (702-731-8224, erikmd@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventricular arrhythmia (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.