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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02423265
Other study ID # IN-US-259-0172 Buch ISR
Secondary ID UMCIRB 13-001574
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date June 2015
Est. completion date March 2017

Study information

Verified date March 2023
Source East Carolina University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anti-anginal drugs relieve ischemia and symptoms by reducing myocardial oxygen demand by reducing heart rate and or contractility (beta-blockers, phenylalkylamine and benzothiazepineate classes of calcium antagonists) or vasodilatation of the venous system (fall in pre-load) and coronary vessels. Late sodium channels remain open for longer in the presence of myocardial ischaemia. Ranolazine, a novel anti-anginal agent, acts by inhibiting the inward late inward sodium current (INaL), reducing intracellular sodium accumulation and consequently intracellular calcium overload via the sodium/calcium exchanger. It is currently thought that this reduction in intracellular calcium reduces diastolic myocardial stiffness and therefore compression of the small coronary vessels. There is considerable animal data to support this theory. There are good theoretical reasons to postulate that patients with chronically occluded vessels may derive less benefit from conventional anti-anginal agents, particularly vasodilators. The ischemic myocardium, subtended by the occluded vessel, will already be subject to significant concentrations of paracrine vasodilators such as adenosine. Ranolazine, therefore, may on the basis of its mechanism of action, provide greater relief of ischemia in such patients than conventional anti-anginal agents.


Description:

To test this hypothesis, a randomized study comparing addition of ranolazine to addition of a minimum of 2 conventional anti-anginal agents in patients with chronic total occlusions would be required. To be sufficiently powered, this would require a significant number of patients recruited in a multi-center trial. This study is an initial pilot study with inactive placebo, not addition of a conventional anti-anginal agent, as the control using MRI imaging data as the primary end-point.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Angiographically proven coronary artery disease with chronic stable angina for at least 3 months. - Abnormal stress test (treadmill ECG, nuclear stress test, dobutamine stress echocardiogram or stress perfusion cardiac MRI) - = 1 chronically occluded coronary artery of a dominant coronary vessel or the left anterior descending artery and/or = 1 occluded vein graft to chronically occluded native coronary vessel - Subjects must be taking a minimum of 2 anti-anginal agents: Exclusion Criteria:• Coronary revascularization in the preceding 2 months - LVEF < 40 - Terminal illness such as cancer - Occluded recessive coronary vessel - Hepatic insufficiency, - Liver cirrhosis, - Prolonged QT interval on ECG, - Severe renal failure (see below), Excluding patients with CrCl < 30 - Drugs that are strong inhibitors of CYP3A such as, ketoconazole, macrolide antibiotics and HIV protease inhibitors. - Limit Ranolazine to 500mg BID in patients on concurrent diltiazem/verapamil - Limit concurrent simvastatin to 20 mg/day - Limit concurrent metformin to 1700 mg/day - Inability to have an MRI scan/known claustrophobia

Study Design


Intervention

Drug:
Ranolazine
Ranolazine: 500 mg twice day, up-titrated after 1 week to 1000 mg twice a day
Placebo
Matching placebo: up-titration after 1 week

Locations

Country Name City State
United States East Carolina Heart Institute at Vidant Medical Center Greenville North Carolina

Sponsors (2)

Lead Sponsor Collaborator
East Carolina University Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac MRI (CMR) strain The extent of reversibly ischaemic LV myocardium will be assessed using CMR strain at rest and stress 8 weeks
Secondary Dobutamine wall motion scoring index (WMSI) CMR derived end point 8 weeks
Secondary Quality of Life/burden of angina QoL questionnaire based assessment (Seattle Angina Quesstionnaire, SAQ; Duke Activity Status Index, DASI;Medical Outcomes Study-Short Form12 ) 8 weeks
Secondary Treadmill ECG exercise distance Functional capacity assessment 8 weeks
Secondary Time to ECG changes (ST depression) on exercise ECG If baseline ECG permits, this will allow assessment of impact of treatment on ECG markers of ischemia 8 weeks
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