Stable AnginaPhase 4IRMANCT02252406
Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome
A Phase 4 study testing Ranolazine in people with Stable Angina and Metabolic Syndrome, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of ranolazine on different markers of cardiometabolic disease in women with stable angina. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Stable Angina, Metabolic Syndrome
- 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
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 17 May 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic stable angina (> 3 months) on evidence based adequate therapy
- Evidence of stable coronary artery disease by any of these:
- MI, PCI or CABG > 30 days prior to enrollment or
- Angiography showing > 50% stenosis in major vessel, branch or bypass graft > 30 days of enrollment or
- Abnormal stress MPI nuclear study, or DBA stress echo where the decision has been to treat medically and where angina has remained stable for >= 3 months
- Evidence of the Metabolic Syndrome: As defined by ATP III criteria i.e 3/5 of following Abdominal circumference F > 88 cm (35 in), M > 102 cm (40 in) Hypertriglyceridemia ≥ 150 mg/dl HDL F < 50 mg/dl M < 40 mg/dl Blood Pressure ≥130/85 Fasting Glucose ≥100 mg/dl For reproductive age women, a negative urine pregnancy test is required if all other inclusion criteria are met.
Who cannot join
- Exclusion of patients with contraindications to use of RANEXA, including patients on CYP3A4 inducers/potent inhibitors, and patients with liver cirrhosis.
- Limit dose of RANEXA to 500mg BID in patients on concurrent diltiazem/ verapamil
- Limit concurrent simvastatin to 20 mg/day
- Limit concurrent metformin to 1700 mg/day Additional Exclusion
- Patients with variable -inconsistent symptoms
- Patients with unstable coronary artery disease or revascularization within 30 days of enrollment.
Show all 16Show fewer
- Patients who have known severe liver disease.
- Patients already receiving maximal ranolazine therapy for more than 4 weeks
- Presence of diabetes (AIC≥ 6.5 and /or on insulin therapy or anti-diabetic medication other than metformin) unstable hypothyroidism, active infection, active cancer (or ongoing chemotherapy and/or radiation within a year who are not on remission) and/or recent major surgery or illness.
- Patients with any contraindication to ranolazine see above
- Women of reproductive age are excluded if they are planning to become pregnant in the next 6 -12 months after randomization.
- Patients who are pregnant or lactating
- Documented allergic reaction to ranolazine in the past.
- Unexplained prolongation of the QTc > 500 milliseconds.
- Current or planned co-administration of moderate CYP3A inhibitors (eg, diltiazem, verapamil, aprepitant, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products) is not a full contraindication, if meet inclusion criteria otherwise, these patients could be accepted in trial but dose will be limited to 500 mg BID as stated previously.
- Current or planned co-administration of strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) OR strong CYP3A inducers (eg, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin,carbamazepine, and St. John's Wort) is a contraindication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Ranolazine on Inflammatory, Thrombogenic, Lipogenic, Biomarkers in Women With Angina and Metabolic Syndrome.
The purpose of this study is to determine the effects of ranolazine on different markers of cardiometabolic disease in women with stable angina.
Read the detailed description
Evaluate the ability of ranolazine to favorably modify thrombogenic, inflammatory, lipogenic, oxidative stress and hormonal biomarkers in a relatively short period of time in a group of ethnically diverse women with chronic stable angina and metabolic syndrome.
- Conditions
- Stable Angina, Metabolic Syndrome
- Being tested
- Ranolazine, Placebo
- Keywords
- Stable Angina, Metabolic Syndrome, Women, Biomarkers
- Medical subject headings
- Angina, Stable, 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
Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24
PlaceboOther
Matching placebo tablets daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Experimental | Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy. Receives: Drug: Ranolazine |
| Placebo | Placebo comparator | Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Ranolazine on Hemoglobin A1C
Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)
Measured: Change from baseline to 24 weeks
Impact of Ranolazine on HDL-C Levels in Subjects
Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome
Measured: Change from Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startSep 2015
- Primary completion17 Dec 2018
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gladys P Velarde, MD, FACC, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252406
- Sponsor's protocol ID
- WIRB20141202
- Acronym
- IRMA
- Status last verified
- Mar 2020
- First submitted
- 11 Aug 2014
- Last updated
- 10 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ranolazine on Inflammatory, Thrombogenic, Lipogenic, Biomarkers in Women With Angina and Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT02252406
- Acronym / sponsor ID
- IRMA / WIRB20141202
- Conditions
- Stable Angina, Metabolic Syndrome
- Keywords
- Stable Angina, Metabolic Syndrome, Women, Biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Posted 10 Apr 2020
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 determine the effects of ranolazine on different markers of cardiometabolic disease in women with stable angina.
Detailed description
Evaluate the ability of ranolazine to favorably modify thrombogenic, inflammatory, lipogenic, oxidative stress and hormonal biomarkers in a relatively short period of time in a group of ethnically diverse women with chronic stable angina and metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Experimental | Drug: RanolazineRanolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with chronic stable angina (> 3 months) on evidence based adequate therapy
- Evidence of stable coronary artery disease by any of these:
- MI, PCI or CABG > 30 days prior to enrollment or
- Angiography showing > 50% stenosis in major vessel, branch or bypass graft > 30 days of enrollment or
- Abnormal stress MPI nuclear study, or DBA stress echo where the decision has been to treat medically and where angina has remained stable for >= 3 months
Key exclusion criteria (16 listed)
- Exclusion of patients with contraindications to use of RANEXA, including patients on CYP3A4 inducers/potent inhibitors, and patients with liver cirrhosis.
- Limit dose of RANEXA to 500mg BID in patients on concurrent diltiazem/ verapamil
- Limit concurrent simvastatin to 20 mg/day
- Limit concurrent metformin to 1700 mg/day Additional Exclusion
- Patients with variable -inconsistent symptoms
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 500 mg from baseline to week 3 and 1000 mg thereafter until week 24 | Drug | Ranolazine |
| PlaceboMatching placebo tablets daily for 24 weeks. | Other | Placebo |
Primary outcome
Impact of Ranolazine on Hemoglobin A1C
Time frame: Change from baseline to 24 weeks
Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)
Impact of Ranolazine on HDL-C Levels in Subjects
Time frame: Change from Baseline to 24 weeks
Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gladys P Velarde, MD, FACC principal investigator
University of Florida
1 site 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 Stable Angina and Metabolic Syndrome, run by University of Florida 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 6 inclusion and 16 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 10 Apr 2020. 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.
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?
Yes. Results are posted in the registry (first posted 10 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Impact of Ranolazine on Hemoglobin A1C (time frame: Change from baseline to 24 weeks). The study lists 2 primary outcomes in all. 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 10 Apr 2020.