Silent Myocardial IschemiaNCT02611596
Does Ranolazine Decrease Biomarkers of Myocardial Damage in Diabetics
A study testing Ranolazine in people with Silent Myocardial Ischemia and Type 2 Diabetes, run by Walter Reed National Military Medical Center.
Trial summary
The purpose of this investigation is to compare subjects at high risk for silent myocardial ischemia in the placebo group to subjects at high risk for silent myocardial ischemia in the ranolazine group to determine if ranolazine can be used as a treatment to decrease silent myocardial ischemia (SMI). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Silent Myocardial Ischemia, Type 2 Diabetes
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2019
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects at risk for silent myocardial ischemia as defined by:
- Stable ischemic heart disease as defined by:
- Obstruction of at least one epicardial vessel of > 50 percent by invasive or non-invasive coronary angiography, or
- Evidence of ischemia or infarct on SPECT imaging, or
- History of myocardial infarction > 3 months ago, or
- Stent placement (PCI) > 3 months ago, or
Show all 20Show fewer
- Coronary artery bypass grafting (CABG) > 3 months ago AND
- Type 2 diabetics as defined by:
- HgbA1C ≥ 6.5 percent, or
- Fasting Blood Glucose > 125 mg/dL on two or more blood draws, or
- Random Blood Glucose of ≥ 200 mg/dL on a single blood draw, or
- Previous diagnosis of type 2 diabetes listed in the subject's medical record AND
- On Optimal Medical Therapy as defined as being on ALL of the following at time of enrollment:
- Beta Blocker
- Aspirin
- Statin AND
- Females < 60 who have not been free of menstruation for 2 years (menopause diagnosed) or who do not have documented history of hysterectomy must be willing to use at least one form of birth control (including abstinence as an option) for the duration of the study. If condoms are the method chosen, they are strongly urged to use a second form of birth control in addition to condoms.
- AND
- Screening Criteria met:
- hs cTnT > 0.014 ng/mL
Who cannot join
- Percutaneous intervention/stent placement in the past 3 months
- Coronary artery bypass grafting in the past 3 months
- Treatment with ranolazine in the past 12 months
- Significant lung disease, COPD or use of supplemental oxygen
- Cirrhosis
- Estimated Glomerular Filtration Rate (GFR) < 30
Show all 21Show fewer
- Subject taking strong CYP3A inhibitors (ketoconazole, itraconazole, clarithryomycin, nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
- Subject taking strong CYP3A inducers (rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, St. John's wort)
- Subjects taking P-gp Inhibitors (cyclosporine)
- Subject is taking concurrent simvastatin in > 20 mg/day
- Subject is taking metformin > 1700 mg/day
- NYHA Class 3 or 4 Heart Failure (severe)
- Canadian Cardiovascular Society Grade 4 Angina
- Unstable angina defined as a new angina occurring after minimal exercise or at rest OR a significant increase in angina severity (≥ 2 CCS grades) occurring with minimal exertion, with high clinical suspicion of acute coronary syndrome.
- Planned PCI or Cardiac Surgery
- Pregnant females or females trying to become pregnant
- Breast-feeding females
- Subjects younger than age 30 or older than age 85
- Lactose Intolerance (placebo has lactose monohydrate)
- Lactose/Milk allergy (placebo has lactose monohydrate)
- QTc > 500 msec
About this study
Official title: Does Ranolazine Decrease Biomarkers That Indicate Evidence of Myocardial Damage in Diabetics With Stable Ischemic Heart Disease? A Double-blinded, Randomized, Placebo Controlled Trial
The purpose of this investigation is to compare subjects at high risk for silent myocardial ischemia in the placebo group to subjects at high risk for silent myocardial ischemia in the ranolazine group to determine if ranolazine can be used as a treatment to decrease silent myocardial ischemia (SMI). Subjects at high risk for silent myocardial ischemia are defined in this protocol as diabetics with stable ischemic heart disease. This study will look at the impact ranolazine treatment has on biomarkers that have been shown to be highly associated with increased risk of morbidity and mortality in relation to SMI. If the hypothesis is correct, further studies can be conducted to determine if treatment with ranolazine has impact on long-term outcomes such as hospitalizations, myocardial infarction, congestive heart failure or sudden cardiac death.
- Conditions
- Silent Myocardial Ischemia, Type 2 Diabetes
- Being tested
- Ranolazine, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
24 weeks of the assigned medication
PlaceboDrug
Placebo for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Experimental | Subjects will take one 500mg tablet twice daily (500mg BID) for seven days and then increase to two 500mg tablets twice daily (1000mg BID) for the remainder of the study, for a total of 24 weeks. Subjects taking moderate CYP3A4 inhibitors will not participate in upward titration and will remain on 500mg tablet twice daily (500mg BID) for the duration of the trial. Receives: Drug: Ranolazine |
| Placebo | Placebo comparator | Subjects will take one placebo tablet (identical to the 500mg Ranolazine tablet) twice daily (500mg BID) for seven days and then increase to two 500mg tablets twice daily (1000mg BID) for the remainder of the study, for a total of 24 weeks. Subjects taking moderate CYP3A4 inhibitors will not participate in upward titration and will remain on 500mg tablet twice daily (500mg BID) for the duration of the trial. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs cTnT
Does ranolazine decrease hs cTnT in subjects at high risk for silent myocardial ischemia?
Measured: 24 weeks
NT-pro-BNP
Does ranolazine decrease NT-pro-BNP in subjects at high risk for silent myocardial ischemia?
Measured: 24 weeks
hsCRP
Determine the degree of decrease of hs CRP in subjects in the ranolazine group.
Measured: 24 weeks
Secondary outcomes (1)
prevalence of hs cTnT > 99th percentile
Determine the prevalence of hs cTnT greater than the 99th percentile (0.014 ng/mL) in asymptomatic diabetic subjects with stable ischemic heart disease.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Silent Myocardial IschemiaStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Todd C. Villines, Walter Reed National Military Medical Center
- Investigators
- Todd C Villines, MD, Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611596
- Sponsor's protocol ID
- 409189
- Status last verified
- May 2017
- First submitted
- 18 Nov 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Marzilli M, Merz CN, Boden WE, Bonow RO, Capozza PG, Chilian WM, DeMaria AN, Guarini G, Huqi A, Morrone D, Patel MR, Weintraub WS. Obstructive coronary atherosclerosis and ischemic heart disease: an elusive link! J Am Coll Cardiol. 2012 Sep 11;60(11):951-6. doi: 10.1016/j.jacc.2012.02.082.
PubMed 22954239Cannon RO 3rd. Microvascular angina and the continuing dilemma of chest pain with normal coronary angiograms. J Am Coll Cardiol. 2009 Sep 1;54(10):877-85. doi: 10.1016/j.jacc.2009.03.080.
PubMed 19712795Deedwania PC, Carbajal EV. Silent ischemia during daily life is an independent predictor of mortality in stable angina. Circulation. 1990 Mar;81(3):748-56. doi: 10.1161/01.cir.81.3.748.
PubMed 2306826Gibbons RJ, Abrams J, Chatterjee K, Daley J, Deedwania PC, Douglas JS, Ferguson TB Jr, Fihn SD, Fraker TD Jr, Gardin JM, O'Rourke RA, Pasternak RC, Williams SV; American College of Cardiology; American Heart Association Task Force on practice guidelines (Committee on the Management of Patients With Chronic Stable Angina). ACC/AHA 2002 guideline update for the management of patients with chronic stable angina--summary article: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (Committee on the Management of Patients With Chronic Stable Angina). J Am Coll Cardiol. 2003 Jan 1;41(1):159-68. doi: 10.1016/s0735-1097(02)02848-6. No abstract available.
PubMed 12570960Saunders JT, Nambi V, de Lemos JA, Chambless LE, Virani SS, Boerwinkle E, Hoogeveen RC, Liu X, Astor BC, Mosley TH, Folsom AR, Heiss G, Coresh J, Ballantyne CM. Cardiac troponin T measured by a highly sensitive assay predicts coronary heart disease, heart failure, and mortality in the Atherosclerosis Risk in Communities Study. Circulation. 2011 Apr 5;123(13):1367-76. doi: 10.1161/CIRCULATIONAHA.110.005264. Epub 2011 Mar 21.
PubMed 21422391Hallen J, Johansen OE, Birkeland KI, Gullestad L, Aakhus S, Endresen K, Tjora S, Jaffe AS, Atar D. Determinants and prognostic implications of cardiac troponin T measured by a sensitive assay in type 2 diabetes mellitus. Cardiovasc Diabetol. 2010 Sep 15;9:52. doi: 10.1186/1475-2840-9-52.
PubMed 20843304Fornengo P, Bosio A, Epifani G, Pallisco O, Mancuso A, Pascale C. Prevalence of silent myocardial ischaemia in new-onset middle-aged Type 2 diabetic patients without other cardiovascular risk factors. Diabet Med. 2006 Jul;23(7):775-9. doi: 10.1111/j.1464-5491.2006.01910.x.
PubMed 16842483Sprague RS, Ellsworth ML. Vascular disease in pre-diabetes: new insights derived from systems biology. Mo Med. 2010 Jul-Aug;107(4):265-9.
PubMed 20806839Singleton JR, Smith AG, Russell JW, Feldman EL. Microvascular complications of impaired glucose tolerance. Diabetes. 2003 Dec;52(12):2867-73. doi: 10.2337/diabetes.52.12.2867.
PubMed 14633845Ziegler D, Rathmann W, Dickhaus T, Meisinger C, Mielck A; KORA Study Group. Prevalence of polyneuropathy in pre-diabetes and diabetes is associated with abdominal obesity and macroangiopathy: the MONICA/KORA Augsburg Surveys S2 and S3. Diabetes Care. 2008 Mar;31(3):464-9. doi: 10.2337/dc07-1796. Epub 2007 Nov 26.
PubMed 18039804Aranda JM Jr, Hill J. Cardiac transplant vasculopathy. Chest. 2000 Dec;118(6):1792-800. doi: 10.1378/chest.118.6.1792.
PubMed 11115475Omland T, de Lemos JA, Sabatine MS, Christophi CA, Rice MM, Jablonski KA, Tjora S, Domanski MJ, Gersh BJ, Rouleau JL, Pfeffer MA, Braunwald E; Prevention of Events with Angiotensin Converting Enzyme Inhibition (PEACE) Trial Investigators. A sensitive cardiac troponin T assay in stable coronary artery disease. N Engl J Med. 2009 Dec 24;361(26):2538-47. doi: 10.1056/NEJMoa0805299. Epub 2009 Nov 25.
PubMed 19940289Latini R, Masson S, Anand IS, Missov E, Carlson M, Vago T, Angelici L, Barlera S, Parrinello G, Maggioni AP, Tognoni G, Cohn JN; Val-HeFT Investigators. Prognostic value of very low plasma concentrations of troponin T in patients with stable chronic heart failure. Circulation. 2007 Sep 11;116(11):1242-9. doi: 10.1161/CIRCULATIONAHA.106.655076. Epub 2007 Aug 13.
PubMed 17698733Rubin J, Matsushita K, Ballantyne CM, Hoogeveen R, Coresh J, Selvin E. Chronic hyperglycemia and subclinical myocardial injury. J Am Coll Cardiol. 2012 Jan 31;59(5):484-9. doi: 10.1016/j.jacc.2011.10.875.
PubMed 22281251de Lemos JA, Drazner MH, Omland T, Ayers CR, Khera A, Rohatgi A, Hashim I, Berry JD, Das SR, Morrow DA, McGuire DK. Association of troponin T detected with a highly sensitive assay and cardiac structure and mortality risk in the general population. JAMA. 2010 Dec 8;304(22):2503-12. doi: 10.1001/jama.2010.1768.
PubMed 21139111
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ranolazine Decrease Biomarkers That Indicate Evidence of Myocardial Damage in Diabetics With Stable Ischemic Heart Disease? A Double-blinded, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02611596
- Acronym / sponsor ID
- 409189
- Conditions
- Silent Myocardial Ischemia, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 23 Nov 2015 (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 investigation is to compare subjects at high risk for silent myocardial ischemia in the placebo group to subjects at high risk for silent myocardial ischemia in the ranolazine group to determine if ranolazine can be used as a treatment to decrease silent myocardial ischemia (SMI). Subjects at high risk for silent myocardial ischemia are defined in this protocol as diabetics with stable ischemic heart disease. This study will look at the impact ranolazine treatment has on biomarkers that have been shown to be highly associated with increased risk of morbidity and mortality in relation to SMI. If the hypothesis is correct, further studies can be conducted to determine if treatment with ranolazine has impact on long-term outcomes such as hospitalizations, myocardial infarction, congestive heart failure or sudden cardiac death.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Experimental | Drug: RanolazineSubjects will take one 500mg tablet twice daily (500mg BID) for seven days and then increase to two 500mg tablets twice daily (1000mg BID) for the remainder of the study, for a total of 24 weeks. Subjects taking moderate CYP3A4 inhibitors will not participate in upward titration and will remain on 500mg tablet twice daily (500mg BID) for the duration of the trial. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will take one placebo tablet (identical to the 500mg Ranolazine tablet) twice daily (500mg BID) for seven days and then increase to two 500mg tablets twice daily (1000mg BID) for the remainder of the study, for a total of 24 weeks. Subjects taking moderate CYP3A4 inhibitors will not participate in upward titration and will remain on 500mg tablet twice daily (500mg BID) for the duration of the trial. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects at risk for silent myocardial ischemia as defined by:
- Stable ischemic heart disease as defined by:
- Type 2 diabetics as defined by:
- Females < 60 who have not been free of menstruation for 2 years (menopause diagnosed) or who do not have documented history of hysterectomy must be willing to use at least one form of birth control (including abstinence as an option) for the duration of the study. If condoms are the method chosen, they are strongly urged to use a second form of birth control in addition to condoms.
- AND
Key exclusion criteria (21 listed)
- Percutaneous intervention/stent placement in the past 3 months
- Coronary artery bypass grafting in the past 3 months
- Treatment with ranolazine in the past 12 months
- Significant lung disease, COPD or use of supplemental oxygen
- Cirrhosis
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 |
|---|---|---|
| Ranolazine24 weeks of the assigned medication | Drug | Ranolazine |
| PlaceboPlacebo for 24 weeks | Drug | Placebo |
Primary outcome
hs cTnT
Time frame: 24 weeks
Does ranolazine decrease hs cTnT in subjects at high risk for silent myocardial ischemia?
NT-pro-BNP
Time frame: 24 weeks
Does ranolazine decrease NT-pro-BNP in subjects at high risk for silent myocardial ischemia?
hsCRP
Time frame: 24 weeks
Determine the degree of decrease of hs CRP in subjects in the ranolazine group.
1 secondary outcome
prevalence of hs cTnT > 99th percentile
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Background: PubMed 22954239Marzilli M, Merz CN, Boden WE, Bonow RO, Capozza PG, Chilian WM, DeMaria AN, Guarini G, Huqi A, Morrone D, Patel MR, Weintraub WS. Obstructive coronary atherosclerosis and ischemic heart disease: an elusive link! J Am Coll Cardiol. 2012 Sep 11;60(11):951-6. doi: 10.1016/j.jacc.2012.02.082.
- Background: PubMed 19712795Cannon RO 3rd. Microvascular angina and the continuing dilemma of chest pain with normal coronary angiograms. J Am Coll Cardiol. 2009 Sep 1;54(10):877-85. doi: 10.1016/j.jacc.2009.03.080.
- Background: PubMed 2306826Deedwania PC, Carbajal EV. Silent ischemia during daily life is an independent predictor of mortality in stable angina. Circulation. 1990 Mar;81(3):748-56. doi: 10.1161/01.cir.81.3.748.
- Background: PubMed 12570960Gibbons RJ, Abrams J, Chatterjee K, Daley J, Deedwania PC, Douglas JS, Ferguson TB Jr, Fihn SD, Fraker TD Jr, Gardin JM, O'Rourke RA, Pasternak RC, Williams SV; American College of Cardiology; American Heart Association Task Force on practice guidelines (Committee on the Management of Patients With Chronic Stable Angina). ACC/AHA 2002 guideline update for the management of patients with chronic stable angina--summary article: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (Committee on the Management of Patients With Chronic Stable Angina). J Am Coll Cardiol. 2003 Jan 1;41(1):159-68. doi: 10.1016/s0735-1097(02)02848-6. No abstract available.
- Background: PubMed 21422391Saunders JT, Nambi V, de Lemos JA, Chambless LE, Virani SS, Boerwinkle E, Hoogeveen RC, Liu X, Astor BC, Mosley TH, Folsom AR, Heiss G, Coresh J, Ballantyne CM. Cardiac troponin T measured by a highly sensitive assay predicts coronary heart disease, heart failure, and mortality in the Atherosclerosis Risk in Communities Study. Circulation. 2011 Apr 5;123(13):1367-76. doi: 10.1161/CIRCULATIONAHA.110.005264. Epub 2011 Mar 21.
- Background: PubMed 20843304Hallen J, Johansen OE, Birkeland KI, Gullestad L, Aakhus S, Endresen K, Tjora S, Jaffe AS, Atar D. Determinants and prognostic implications of cardiac troponin T measured by a sensitive assay in type 2 diabetes mellitus. Cardiovasc Diabetol. 2010 Sep 15;9:52. doi: 10.1186/1475-2840-9-52.
- Background: PubMed 16842483Fornengo P, Bosio A, Epifani G, Pallisco O, Mancuso A, Pascale C. Prevalence of silent myocardial ischaemia in new-onset middle-aged Type 2 diabetic patients without other cardiovascular risk factors. Diabet Med. 2006 Jul;23(7):775-9. doi: 10.1111/j.1464-5491.2006.01910.x.
- Background: PubMed 20806839Sprague RS, Ellsworth ML. Vascular disease in pre-diabetes: new insights derived from systems biology. Mo Med. 2010 Jul-Aug;107(4):265-9.
- Background: PubMed 14633845Singleton JR, Smith AG, Russell JW, Feldman EL. Microvascular complications of impaired glucose tolerance. Diabetes. 2003 Dec;52(12):2867-73. doi: 10.2337/diabetes.52.12.2867.
- Background: PubMed 18039804Ziegler D, Rathmann W, Dickhaus T, Meisinger C, Mielck A; KORA Study Group. Prevalence of polyneuropathy in pre-diabetes and diabetes is associated with abdominal obesity and macroangiopathy: the MONICA/KORA Augsburg Surveys S2 and S3. Diabetes Care. 2008 Mar;31(3):464-9. doi: 10.2337/dc07-1796. Epub 2007 Nov 26.
- Background: PubMed 11115475Aranda JM Jr, Hill J. Cardiac transplant vasculopathy. Chest. 2000 Dec;118(6):1792-800. doi: 10.1378/chest.118.6.1792.
- Background: PubMed 19940289Omland T, de Lemos JA, Sabatine MS, Christophi CA, Rice MM, Jablonski KA, Tjora S, Domanski MJ, Gersh BJ, Rouleau JL, Pfeffer MA, Braunwald E; Prevention of Events with Angiotensin Converting Enzyme Inhibition (PEACE) Trial Investigators. A sensitive cardiac troponin T assay in stable coronary artery disease. N Engl J Med. 2009 Dec 24;361(26):2538-47. doi: 10.1056/NEJMoa0805299. Epub 2009 Nov 25.
Related trials for Silent Myocardial Ischemia
RecruitingObservational study
Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease
Coronary Arterial Disease (CAD), NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
Enrolling by invitationObservational study
Multicenter Study on Cardiovascular and Metabolic Complications in Patients With Biochemically Silent Pheochromocytomas and Paragangliomas
Cardiovascular Abnormalities, Arterial Blood Pressure
Recruiting
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
Coronary Artery Disease, Chronic Stable Angina
Active, not recruitingObservational study
INsTantenous wavE-Free Ratio-guided PCI Versus Fractional Flow REserve-Guided PCI in rouTine Clinical Practice, Prospective, Multicenter Registry
Stable Angina, Non ST Segment Elevation Myocardial Infarction
Enrolling by invitationObservational study
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
Cardiopulmonary Failure, Myocardial Infarction (MI)
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.
Todd C Villines, MD principal investigator
WRNMMC
Questions about this trial
What is this clinical trial studying?
A study testing Ranolazine in people with Silent Myocardial Ischemia and Type 2 Diabetes, run by Walter Reed National Military Medical Center.
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 20 inclusion and 21 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: withdrawn, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
hs cTnT (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611596, which also lists 22 linked publications.
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 17 May 2017.