Coronary Artery DiseasePhase 4REMSNCT01304095
Ranolazine, Ethnicity and the Metabolic Syndrome
A Phase 4 study testing Ranolazine in people with Coronary Artery Disease and Angina, run by Atlanta Heart Specialists, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina, Metabolic Syndrome
- What is being tested?
- Ranolazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of stable Coronary Artery Disease
- MI > 30 days prior to enrollment
- PCI > 30 days prior to enrollment
- CABG > 30 days prior to enrollment
- Angiography showing > 50% stenosis in a major vessel, branch or bypass graft > 30 days prior to enrollment
- Metabolic Syndrome as evidenced by at least one of the following risk factors:
Show all 18Show fewer
- Abdominal Obesity (elevated waist circumference)
- Men - waist circumference ≥ 40 inches (102 cm) Asians/Asian Americans ≥ 35.5 inches (90 cm)
- Women - waist circumference ≥ 35 inches (88 cm) Asians/Asian Americans ≥ 31.5 inches (80 cm)
- Atherogenic dyslipidemia (either one or both)
- Triglycerides ≥ 150 mg/dL
- Reduced HDL Men - HDL ≤ 40 mg/dL Women - HDL ≤ 50 mg/dL
- Elevated Blood Pressure (equal to or greater than 130/85)
- Elevated fasting glucose (equal to or greater than 100 mg/dL)
- Symptoms of angina or a suspected angina equivalent (upper body chest pain, shortness of breath, fatigue)
- Patient able to perform an exercise treadmill test (ETT)
- Written informed consent
- Age > 18 years old
Who cannot join
- Unstable coronary artery disease or revascularization within 30 days of enrollment.
- Patients who have a prolonged QTc interval (>500ms)
- Patients who have known severe liver disease
- Current or planned co-administration of strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) OR CYP3A inducers (eg, rifampin, rifabutin, rifapentine, Phenobarbital, phenytoin, carbamazepine, and St. John's Wort) OR moderate CYP3A inhibitors (eg, diltiazem, verapamil, aprepitant, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products)
- Patients who are pregnant or lactating
- Patients who are likely to be noncompliant with study procedures
- Patients currently in a study, or within 30 days of participating in a study, of an investigational drug or device
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Heart Specialist, LLC
Cumming, Georgia, 30041
Atlanta Heart Specialists, LLC
Tucker, Georgia, 30084
About this study
Official title: Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study
The purpose of this study is to measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian.
Read the detailed description
Studies have shown that various ethnic subgroups are at differential risk for both the development and progression of coronary artery disease. The East Indian population is one of the highest risk populations for coronary artery disease. Much of this increased risk is driven by the development and progression of diabetes.
Recent studies have shown that ranolazine has a favorable effect on glycemic control. In addition, it is an effective antianginal and antiarrhythmic agent.
The investigators propose a pilot study look at the safety, tolerability and efficacy of this agent in patients with established coronary artery disease (CAD) and risk factors for the metabolic syndrome from various ethnic backgrounds. In particular the investigators will focus on the Caucasian, African American, Southeast Asian and East Indian population.
- Conditions
- Coronary Artery Disease, Angina, Metabolic Syndrome
- Being tested
- Ranolazine
- Keywords
- Coronary Artery Disease, Angina, Metabolic Syndrome
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
Patients in the ranolazine arm would start with 500 mg po BID of ranolazine and be force titrated to 1gm po BID after 2 weeks. Down-titration would only be allowed for side effects. This would be on top of all standard medical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Active comparator | Ranolazine in addition to standard of care medical therapy Receives: Drug: Ranolazine |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Duration
To measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian.
Measured: change from baseline to 6 months
Secondary outcomes (5)
fasting glucose
To measure the effect ranolazine has on fasting blood glucose.
Measured: change from baseline to 6 months
Angina
To look at the effect of ranolazine on anginal episodes using the Seattle Angina Questionnaire (SAQ).
Measured: change from baseline to 6 months
Concomitant medications
To measure the impact of ranolazine on reducing concomitant medication therapy such as anti-arrhythmic agents, hypoglycemic agents, and nitrates.
Measured: change from baseline to 6 months
lipid profile
To measure the effect ranolazine has on lipid profile.
Measured: change from baseline to 6 months
HgbA1c
To measure the effect ranolazine has on hemoglobin A1c.
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlanta Heart Specialists, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Narendra Singh, MD, Atlanta Heart Specialists, LLC
- Investigators
- Narendra Singh, MD, Principal investigator, Atlanta Heart Specialists, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304095
- Sponsor's protocol ID
- AHS-REMS-001
- Acronym
- REMS
- Status last verified
- Jul 2013
- First submitted
- 16 Feb 2011
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study
- ClinicalTrials.gov ID
- NCT01304095
- Acronym / sponsor ID
- REMS / AHS-REMS-001
- Conditions
- Coronary Artery Disease, Angina, Metabolic Syndrome
- Keywords
- Coronary Artery Disease, Angina, Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Atlanta Heart Specialists, LLCUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (estimated)
- First posted
- 25 Feb 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 measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian.
Detailed description
Studies have shown that various ethnic subgroups are at differential risk for both the development and progression of coronary artery disease. The East Indian population is one of the highest risk populations for coronary artery disease. Much of this increased risk is driven by the development and progression of diabetes.
Recent studies have shown that ranolazine has a favorable effect on glycemic control. In addition, it is an effective antianginal and antiarrhythmic agent.
The investigators propose a pilot study look at the safety, tolerability and efficacy of this agent in patients with established coronary artery disease (CAD) and risk factors for the metabolic syndrome from various ethnic backgrounds. In particular the investigators will focus on the Caucasian, African American, Southeast Asian and East Indian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Active comparator | Drug: RanolazineRanolazine in addition to standard of care medical therapy |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Evidence of stable Coronary Artery Disease
- Metabolic Syndrome as evidenced by at least one of the following risk factors:
- Symptoms of angina or a suspected angina equivalent (upper body chest pain, shortness of breath, fatigue)
- Patient able to perform an exercise treadmill test (ETT)
- Written informed consent
Key exclusion criteria (7 listed)
- Unstable coronary artery disease or revascularization within 30 days of enrollment.
- Patients who have a prolonged QTc interval (>500ms)
- Patients who have known severe liver disease
- Current or planned co-administration of strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) OR CYP3A inducers (eg, rifampin, rifabutin, rifapentine, Phenobarbital, phenytoin, carbamazepine, and St. John's Wort) OR moderate CYP3A inhibitors (eg, diltiazem, verapamil, aprepitant, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products)
- Patients who are pregnant or lactating
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: RanexaPatients in the ranolazine arm would start with 500 mg po BID of ranolazine and be force titrated to 1gm po BID after 2 weeks. Down-titration would only be allowed for side effects. This would be on top of all standard medical therapy. | Drug | Ranolazine |
Primary outcome
Exercise Duration
Time frame: change from baseline to 6 months
To measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian.
5 secondary outcomes
fasting glucose
Time frame: change from baseline to 6 months
Angina
Time frame: change from baseline to 6 months
Concomitant medications
Time frame: change from baseline to 6 months
lipid profile
Time frame: change from baseline to 6 months
HgbA1c
Time frame: change from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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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.
Narendra Singh, MD principal investigator
Atlanta Heart Specialists, LLC
2 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 Coronary Artery Disease and Angina, run by Atlanta Heart Specialists, LLC at 2 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 18 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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
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?
Exercise Duration (time frame: change from baseline to 6 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 11 Jul 2013.