Cardiovascular Disease

 

AstraZeneca

A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease. The study will compare the effects of these two FDA-approved statin drugs on the ability to decrease progression or induce regression of atherosclerosis in high risk patients following two years of treatment. Atherosclerosis is the process in which plaque deposits build up in the inner lining of arteries, and is the main cause of cardiovascular disease. This study is currently in follow-up.

Contact: Ronnier Aviles MD, Principle Investigator at 425-456-8712.

 

Acute Coronary Syndrome Study
A study to compare the clinical benefit of two lipid-lowering drugs in patients with acute coronary syndrome (a heart attack or heart/chest pain). Patients can enter the study at a cardiology clinic visit, but must be recently hospitalized for ACS and meet certain specific requirements.

Contact: James Leggett MD, Principal Investigator at 425-456-8712.

 

Antiplatelet Therapy Study
This is a study of a new antiplatelet medication for patients who have documented atherosclerotic disease, including coronary artery disease (CAD) and cerebrovascular disease (CVD). The benefit of anitplatelet agents in secondary prevention of atherothrombotic events is well established. The purpose of the study is to evaluate whether adding the study drug to standard of care antiplatelet therapy will reduce the incidence of atherothrombotic ischemic events, such as myocardial infraction (heart attack), stroke, and urgent coronary revascularization (balloon angioplasty or stenting) as compared to standard of care alone. This study is currently in follow-up. 

Contact: Neal Perlmutter, MD or Edward Kim, MD at 425-456-8712. 

 

CHAMPION PCI – The Medicines Company
A study of a new IV anti-platelet medication for patients who are to undergo PCI (Percutaneous Coronary Intervention). There is currently no short acting platelet inhibitor approved for acute patient care. The investigational drug, not yet approved by the FDA, acts quickly with up to 95% platelet inhibition and full recovery of platelet function in less than 60 minutes with little or no kidney concerns. The use of inhibitors is essential to better patient outcomes and recovery. This study is currently in follow-up.

Contact: Thomas Amidon MD, Principal Investigator at 425-456-8712.

 

CORAL – National Institutes of Health
A study designed to establish optimal care for patients with high blood pressure caused by renal artery stenosis (RAS - narrowed arteries to the kidneys). The study will compare medical therapy augmented by stenting of the renal arteries (insertion of a scaffold-like tube made of wire mesh), with medical therapy alone in patients with high blood pressure caused by RAS.   For more information about this important clinical trial, please visit here. This study is currently in follow-up. 

Contact: James Leggett MD at 425-456-8712.

 

CYPRESS - Cordis Corporation

This research study will be using drug-coated coronary artery stents. These stents are small, flexible metal devices coated with a drug called sirolumus. Sirolimus is a drug approved by the United States Food and Drug Administration (FDA) which slows down or prevents the coronary arteries from closing again. These stents are placed inside the narrowed coronary artery to help keep it open. CYPHER® is the name of the drug-coated coronary artery stent used in this study. The CYPHER® stent is approved by the FDA. The experimental part of this study, which is not approved by the FDA, is the continuation of the anti-platelet drugs after 12 months for a further 18 months. Patients will also take aspirin, plus clopidogrel (Plavix®) or prasugrel (Effient™) or a placebo (an inactive substance).

Contact: James Leggett MD at 425-456-8712.

 

RATE - St. Jude Medical
Registry to follow patients with certain risk factors to see how many patients in this risk group develop Atrial Fibrillation to know the prevalence of this disease that affects patients' quality of life and length of life. This study is currently in follow-up.

Contact: Derek Rodrigues, MD at 425-456-8712.

 

 

SAVOR
The purpose of this Phase IV study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications in patients with Type 2 Diabetes.

Contact: Ronnier Aviles, MD, Principal Investigator at 425-456-8712.

 

SCORE - St. Jude Medical
Registry following patient Pacemaker or ICD/CRT-D measured data to follow battery longevity and any adverse events in order to improve future devices for that sponsor.

Contact: Derek Rodrigues, MD at 425-456-8712.

 

SOLID TIMI 52 - GlaxoSmithKline

This study will test whether darapladib (an oral tablet) can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) when treatment is started within 30 days after an acute coronary syndrome (also called ACS). Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard thereapy. Following the baseline (first) visit, subjects will be expected to return for clinic visits at one month, three months, six months and every six months until the end of the study.

Contact: Nathan Zilz, MD or Edward Kim, MD at 425-456-8712.

 

TRACER
Phase III study in OIMA Cardiology patients with non-ST elevation acute coronary syndrome (NSTEACS) who present within 24 hrs of symptom onset can be randomized to a double-blind, placebo-controlled study comparing placebo plus usual care (including plavix and aspirin) to SCH 530348 (also called TRA or Thrombin Receptor Antagonist) plus usual care.  A loading dose of 40 mg will be administered in the hospital at least 1 hr prior to intervention.  The patients will be maintained on a 2.5 mg  dose for at least one year and up to two years and a half years.  Warfarin/Coumadin is an exclusion to participation.  This study is sponsored by Schering Plough. 

Contact: Ronnier Aviles, MD, Principal Investigator at 425-456-8712.

 

XIENCE V
A prospective, open-label, multi-center, observational, single-arm registry designed to evaluate XIENCE V Everolimus Eluting Coronary Stent System (EECSS) continued safety and efficacy during commercial use in real world settings. This registry is a long term surveillance study of an FDA-approved drug eluting stent (DES) when used by a broad group of physicians at a variety of health care facilities. Patients who agree to participate and receive one or more XIENCE stents will be followed primarily by telephone contact for 5 years. Adjunctive anti-platelet drug therapy is a critical factor in optimizing long term DES safety, but many patients who receive drug eluting stents stop taking these medications early. XIENCE V registry follow-up will also document ongoing adherence to recommended dual anti-platelet regimen.

Contact: James Leggett, MD, Principal Investigator at 425-456-8712.

 

Heart Failure & Arrhythmia

 

Atrial Fibrillation Study
A study to compare a new blood thinning drug to Warfarin in patients with atrial fibrillation (rapidly fired signals to the heart causing it to beat irregularly or very fast). Blood thinning drugs help prevent strokes in people with A-Fib.

Contact: Derek Rodrigues, MD at 425-456-8712.

 

Atrial Fibrillation Study
A study to evaluate the potential benefit of ICD (implantable cardioverter-defibrillator) device programs designed to prevent the first episode of atrial fibrillation (A-Fib) in high-risk ICD patients with no prior history of A-Fib. This study is currently in follow-up.

Contact: J. Alan Heywood, MD at 425-456-8712.

 

Heart Failure & Anemia
A study to investigate the safety and effectiveness of an investigational drug to treat anemia in patients with worsening heart failure.

Contact: Mark Vossler, MD at 425-456-8712.

 

Noise Detection Algorithm Study - St. Jude
The sponsor is developing software (called the Noise Detection Algorithm). The purpose is to allow devices in patients to recognize the difference between when an implanted wire is no longer working properly and when the device is sensing extra signals, sometimes known as noise. The purpose of this study is to create and collect signals that the implanted device detects and records from the wire that is implanted in the right side of the heart. This data will then be used by the sponsor to test and help develop this new software.

Contact: Derek Rodrigues, MD, Principal Investigator at 425-456-8712.

 

SMART AV
The primary objective of SMART-AV is to assess the effect of Smart Delay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period. This study is currently in follow-up.

Principal Investigator: Jeffrey Fowler, MD; Co-Investigator: J. Alan Heywood, MD;  Contact: Dr. Fowler  425-899-1354.

 

TOPCAT - National Institutes of Health  
Half of the heart failure population has diastolic heart failure, but there is very little research for them.   With this study which focuses on diastolic heart failure , the drug spironolactone, an inhibitor of the hormone aldosterone, has improved the survival of people with significant, symptomatic systolic heart failure.  The purpose of TOPCAT is to determine if treatment with spironolactone can produce a significant reduction in cardiovascular mortality, aborted cardiac arrest, or hospitalization for the treatment of heart failure in adults with a left ventricular ejection fraction of at least 45%. 

Contact:  Mark R. Vossler, M.D. at 425-456-8712.