Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronary Artery Disease, Angina Pectoris

In brief

This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

Key facts

Study ID

NCT01442038

Run by

Gilead Sciences

People needed

2651

Starts

2011-10-01

Expected to finish

2015-02-01

Last updated by the study team

2016-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Males and females aged 18 years and older
• History of chronic angina defined as at least 2 episodes of anginal pain or discomfort in the chest, jaw, shoulder, back, neck, or arm that is precipitated by exertion or emotional stress, and relieved by rest or sublingual nitroglycerin, which occurred on at least 2 separate days and at least 14 days prior to PCI (in the case of staged PCI procedures, at least 14 days prior to the first PCI in the series). Participants may or may not have additional angina episodes within the 14 days prior to their first PCI in the series, as well as any time prior to Randomization.
• PCI for any indication (ACS or non-ACS). For the purposes of stratification at randomization, ACS will be defined as hospitalization for anginal pain or discomfort within the previous 24 hours to their hospitalization with any one (or more) of the following criteria:
• i. Elevated troponin or creatinine kinase-MB (CK-MB) consistent with myocardial infarction (MI), as reported by local laboratory and measured prior to index PCI ii. Electrocardiographic changes (including transient changes) comprising new or presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle Branch Block
• Randomization within 14 days post-PCI. In the case of staged PCI procedures, randomization has to occur within 14 days of the last PCI in the series. Participants may be randomized starting on the day of PCI and anytime during the following 14 days. PCI is defined as an attempt to cross the lesion with a wire with the intention of performing revascularization.
• Post-PCI (post the last PCI for staged procedures) evidence of incomplete revascularization defined as the presence of one or more visually estimated ≥ 50% stenoses in one or more coronary arteries with reference vessel diameter of at least 2.0 mm, whether in the target vessel or in a non-target vessel regardless of the presence or absence of coronary collaterals. In the case of a participant post-coronary artery bypass grafting (CABG), incomplete revascularization is defined as the presence of one or more visually estimated ≥ 50% stenoses in an unbypassed epicardial vessel with a reference diameter of ≥ 2.0 mm, or one or more visually estimated ≥ 50% stenoses in a bypass graft supplying an otherwise unrevascularized myocardial territory.
• Clinically stable post-PCI. Participants randomized in-hospital on day of planned discharge or in clinic are considered stable. Participants randomized in-hospital prior to day of planned discharge must meet all of the following criteria:
• i. CK-MB < 3 times the upper limit of normal (ULN) at least 3 hours post-PCI, or if ≥ 3 times the ULN with evidence of decreasing CK-MB (decreased by at least 20% from the prior measurement) as reported by local laboratory. If CK-MB is not available, a participant must have evidence of normal or decreasing troponin levels (by at least 20% from the prior measurement) at least 3 hours post-PCI, as reported by local laboratory.
• ii. Systolic blood pressure ≥ 90 mm Hg and not receiving pressors or inotropes iii. No current requirement for an intra-aortic balloon pump (IABP) or any left ventricular assist device iv. No current requirement for intravenous (IV) nitroglycerin
• Ability and willingness to comply with all study procedures during the course of the study
• Females of childbearing potential must have a negative pregnancy test at Screening (unless surgically sterile or post-menopausal) and must agree to use highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.

You may not qualify if…

• Any future planned revascularization (including staged procedures) or possible planned revascularization (ie, planned stress test to assess the imminent need for additional revascularization). Future planned stress tests for purposes of monitoring are permitted but strongly discouraged. Participants may be enrolled after the last PCI in the staged series or once a decision is made not to perform a follow up PCI, as long as Randomization occurs within 14 days from the last PCI. If a participant has had a stress test post-PCI and prior to Randomization and no further intervention is planned, the participant may be enrolled within 14 days from the last PCI.
• Unrevascularized left main coronary artery stenosis ≥ 50%. Participants with a history of CABG to the left coronary system will be considered to have a revascularized left main if at least one graft is patent.
• Major complication during or after the index PCI (in the case of staged PCI, the last in the series) including:
• i. Major bleeding (TIMI Bleeding classification or any bleeding requiring blood transfusion of ≥ 2 units of red blood cells) ii. Coronary perforation requiring treatment iii. Procedural complication requiring surgery (including CABG or peripheral vascular surgery)
• Stroke within 90 days prior to Randomization, or any history of stroke with permanent major neurologic disability (eg, aphasia or significant motor dysfunction)
• Cardiogenic shock within 90 days prior to Randomization (transient decreases in blood pressure without clinical sequelae are not considered to be cardiogenic shock)
• New York Heart Association (NYHA) Class III or IV heart failure
• Severe renal insufficiency as assessed by an estimated glomerular filtration rate < 30 mL/min/1.73m2 using the 4 variable modification of diet in renal disease (MDRD) equation per local laboratory (based on the last available measurement prior to Randomization, collected within 1 month prior to the index PCI [in the case of staged PCI, the last in the series])
• Liver cirrhosis
• Use of Class Ia, Ic, or Class III antiarrhythmics, except for amiodarone
• Current treatment with strong inhibitors of CYP3A
• Current treatment with CYP3A4 inducers or P-gp inducers
• Participants taking > 20 mg simvastatin daily or > 40 mg lovastatin daily who cannot reduce the dose to 20 mg once daily for simvastatin or 40 mg once daily for lovastatin, or who cannot switch to another statin
• Participants taking greater than a total of 1000 mg daily of metformin who cannot reduce the dose to a maximum total of 1000 mg daily (additional anti-diabetic medications may be added as clinically indicated to allow participants to decrease their metformin dose and maintain glycemic control)
• Previous treatment with ranolazine for > 7 consecutive days within 30 days prior to Randomization, or known hypersensitivity or intolerance to ranolazine or to any of the excipients
• Participation in another investigational drug or investigational device study within 30 days prior to Randomization (participation in registries is allowed)
• Women who are pregnant or breast feeding
• Non-coronary artery disease comorbid conditions (eg, advanced malignancy, severe aortic stenosis) which are likely to result in death within 2 years of Randomization
• Any condition that in the opinion of the investigator would preclude compliance with the study protocol

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Heart Center Research, LLC — Huntsville, Alabama, United States
• Scottsdale Healthcare — Scottsdale, Arizona, United States
• Scottsdale Healthcare — Scottsdale, Arizona, United States
• University of California San Diego — La Jolla, California, United States
• Spectrum Clinical Research Institute, Inc — Moreno Valley, California, United States
• Veterans Affairs San Diego Healthcare System — San Diego, California, United States
• John Muir Medical Center Concord Campus — Walnut Creek, California, United States
• South Denver Cardiology Associates, PC — Littleton, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Cardiology Associates of Fairfield County, PC — Stamford, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Zasa Clinical Research — Atlantis, Florida, United States
• Cardiology Research Associates — Daytona Beach, Florida, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Michigan Heart, PC — Hialeah, Florida, United States
• Jacksonville Heart Center — Jacksonville, Florida, United States
• University of Florida Health Sciences Center-Jacksonville — Jacksonville, Florida, United States
• East Coast Institute for Research — Jacksonville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Florida Heart Institute — Orlando, Florida, United States
• Cardiovascular Institute of Northwest Florida — Panama City, Florida, United States
• Cardiology, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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