ArrhythmiaNCT01480336
The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot
A study testing Amiodarone Plus Ranolazine in people with Arrhythmia, run by Hartford Hospital at 1 site in United States.
Trial summary
The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Amiodarone Plus Ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jan 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with an ICD who were on a stable dose of amiodarone for the past 60 days
Who cannot join
- Patients with a life expectancy of less than 6 months
- Patients with moderate or severe hepatic impairment (Child-Pugh Classes B or C) or requiring hemodialysis.
- Pregnancy or lactation.
- Treatment with potent CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir
- Treatment with CYP3A inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pharmacokinetics and Electrocardiographic Implications of Adjunctive Amiodarone and Ranolazine Therapy in Patients on Implantable Cardioverter Defibrillators: The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot
The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.
- Conditions
- Arrhythmia
- Being tested
- Amiodarone Plus Ranolazine, Amiodarone with Placebo
- Keywords
- Arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone Plus RanolazineDrug
Ranolazine 500mg by mouth twice daily
Amiodarone with PlaceboDrug
stabel dose of amiodarone as prescribed by cardiologist
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone with Placebo | Placebo comparator | Not described Receives: Drug: Amiodarone with Placebo |
| Amiodarone with Ranolazine | Active comparator | Not described Receives: Drug: Amiodarone Plus Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter Estimates
Absorption, Peak concentration, time to peak concentration, clearance, area under the curve
Measured: 12 hours
Secondary outcomes (1)
Electrocardiogram (ECG)
The QT/QTc interval and other ECG parameters
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- William Baker, Pharm.D., Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480336
- Sponsor's protocol ID
- KLUG003330HE
- Status last verified
- Mar 2013
- First submitted
- 23 Nov 2011
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Electrocardiographic Implications of Adjunctive Amiodarone and Ranolazine Therapy in Patients on Implantable Cardioverter Defibrillators: The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot
- ClinicalTrials.gov ID
- NCT01480336
- Acronym / sponsor ID
- KLUG003330HE
- Conditions
- Arrhythmia
- Keywords
- Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Nov 2011 (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.
The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone with Placebo | Placebo comparator | Drug: Amiodarone with Placebo |
| Amiodarone with Ranolazine | Active comparator | Drug: Amiodarone Plus Ranolazine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an ICD who were on a stable dose of amiodarone for the past 60 days
Key exclusion criteria (5 listed)
- Patients with a life expectancy of less than 6 months
- Patients with moderate or severe hepatic impairment (Child-Pugh Classes B or C) or requiring hemodialysis.
- Pregnancy or lactation.
- Treatment with potent CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir
- Treatment with CYP3A inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort.
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 |
|---|---|---|
| Amiodarone Plus RanolazineRanolazine 500mg by mouth twice daily | Drug | Amiodarone with Ranolazine |
| Amiodarone with Placebostabel dose of amiodarone as prescribed by cardiologist | Drug | Amiodarone with Placebo |
Primary outcome
Pharmacokinetic Parameter Estimates
Time frame: 12 hours
Absorption, Peak concentration, time to peak concentration, clearance, area under the curve
1 secondary outcome
Electrocardiogram (ECG)
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
Related trials for Arrhythmia
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
William Baker, Pharm.D. principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amiodarone Plus Ranolazine in people with Arrhythmia, run by Hartford Hospital at 1 site 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameter Estimates (time frame: 12 hours). 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 19 Mar 2013.