eCardioVascular Beat

This study will assess the efficacy of prasugrel versus clopidogrel in subjects with coronary artery disease who have undergone successful elective PCI with placement of at least one drug-eluting stent and whose on-clopidogrel P2Y12 reaction units (PRU) value, as measured by the VerifyNow™ P2Y12 assay, is >208. The intent of this study is to demonstrate that prasugrel is superior to clopidogrel in preventing the composite endpoint of Clinical Events Committee (CEC) adjudicated cardiovascular death or MI in this subject population with high on-clopidogrel platelet reactivity.

Key inclusion criteria

Subjects with CAD who underwent PCI with implantation of at least one DES

• VerifyNow™ P2Y12 PRU >208, measured two to seven hours after a clopidogrel maintenance dose
• PCI performed with unfractionated or low molecular weight heparin, or bivalirudin as the procedural antithrombin

Key exclusion criteria

• Subjects who exhibit NSTEMI; or STEMI within 14 days prior to randomization
• New York Heart Association (NYHA) Class IV congestive heart failure
• Active internal bleeding or history of major bleeding diathesis, clinical findings associated with an increased risk of bleeding, history of hemorrhagic or ischemic stroke, a transient ischemic attack, or sub-arachnoid hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm, or non-cardiac surgery within four weeks prior to PCI

Principal investigator

Ty Gluckman, M.D.

Sponsor

Eli Lilly and Company

Contact

Heather Aiona, C.C.R.C., clinical research coordinator, at
heather.aiona@providence.org or 503-216-2099

Antiplatelet medications, such as clopidogrel (Plavix) or prasugrel (Effient), are approved treatments that block the function of platelets in the blood, and prevent the formation of clots that could block blood flow to the heart. These medications are often used in patients who have had heart disease and who have undergone a procedure called angioplasty or stenting to open up a blocked artery feeding the heart.

The purpose of this study is to evaluate the effectiveness of these medicines and to examine how doctors prescribe these medications for short- and long-term use. This is an observational study, which means no investigational treatments or procedures will be performed as a result of this study. Subjects’ treatment and medical care will not change by taking part in this study. Physicians will continue to make all decisions regarding proper treatment and care.

Up to 17,350 people will take part in this study at 350 medical centers located around the United States. Up to 200 people may take part in this study at Providence St. Vincent Medical Center.

Principal investigator

Ty Gluckman, M.D.

Sponsor

Ely Lilly and Company

Contact

Angela Redd, C.C.R.C., clinical research coordinator, at
angela.redd@providence.org or 503-216-2170

Enrollment criteria

Subjects with PFO who have had a "cryptogenic stroke" within the last 270 days. Call for more specific inclusion/exclusion criteria.

Principal investigator

Todd Caulfield, M.D.

Sponsor

AGA Medical Corp.

Contact

Eric Johnson, C.C.R.C., clinical research supervisor, at
eric.johnson@providence.org or 503-216-2075.

Principal investigator

Todd Caulfield, M.D.

Occluder sponsor

AGA Medical Corp.

Contact

Eric Johnson, C.C.R.C., clinical research supervisor, at
eric.johnson@providence.org or 503-216-2075.

Enrollment criteria

Patients undergoing PCI with either DES or BMS without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation

Principal investigator

Todd Caulfield, M.D.

Sponsor

Harvard Clinical Research Institute (HCRI)

Contact

Heather Aiona, C.C.R.C., clinical research coordinator, at
heather.aiona@providence.org or 503-216-2099.

Principal investigator

Jeffrey Swanson, M.D.

Sponsor

St. Jude Medical Cardiovascular Division

Contact

Heather Aiona, C.C.R.C., clinical research coordinator, at
heather.aiona@providence.org or 503-216-2099.

Principal investigator

Anthony Furnary, M.D.

Sponsor

Providence Heart and Vascular Institute with funding from Sanofi-Aventis and LifeScan Inc.

Contact

Eric Johnson, C.C.R.C., clinical research supervisor, at
eric.johnson@providence.org or 503-216-2075.

Inclusion criteria

• Patient is between ages of 18 to 80 years old
• Documented longstanding persistent Afib OR non self-terminating Afib
• Patient scheduled for concomitant cardiac procedure

Exclusion criteria

• EF <30%
• History of Afib >10 years
• Left atrial size >6.0

Principal investigator

E. Charles Douville, M.D.

Sponsor

nContact Surgical Inc.

Contact

Michelle Dixon, C.C.R.C., clinical research coordinator, at
michelle.dixon@providence.org or 503-215-6746.

Inclusion criteria

• Patient is scheduled to receive ON-X mechanical valve (aortic or mitral)
• Concomitant cardiac surgery IS allowed

Exclusion criteria

• Double (aortic and mitral) valve REPLACEMENT
• Patients with ACTIVE endocarditis
• Previous thromboembolic event within last year

Principal investigator

E. Charles Douville, M.D.

Sponsor

On-X/MCRI

Contact

Michelle Dixon, C.C.R.C., clinical research coordinator, at
michelle.dixon@providence.org or 503-215-6746.

Inclusion criteria

• Have documented AF episodes >2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week
• Warrant active therapy beyond simple ongoing observation
• Be eligible for catheter ablation and >2 sequential rhythm control and/or >3 rate control drugs
• Be >65 years of age, or <65 years with one or more of the following risk factors for stroke: hypertension, diabetes, congestive heart failure (including systolic or diastolic heart failure), prior stroke or TIA, LA size >5.0cm (or volume index >44cc/m2) or EF<35. Subjects <65 years of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify

Exclusion criteria

• Lone AF in absence of risk factors for stroke in patients <65 years of age
• Patients who in the opinion of managing clinician should not yet receive any therapy for AF
• Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects
• More than 1 week of amiodarone treatment in the past 3 months
• An efficacy failure of full-dose amiodarone treatment >12 weeks duration at any time

Principal investigator

Blair Halperin, M.D.

Sponsor

National Heart Lung and Blood Institute (NHLBI)

Contact

Heather Aiona, C.C.R.C., clinical research coordinator, at
heather.aiona@providence.org or 503-216-2099.

Inclusion criteria

• Presence of typical atrial flutter (cavotricuspid isthmus dependent)
• If subjects receiving antiarrhythmic drug therapy (Class I or Class III AAD) for arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and subsequently had another arrhythmia (i.e. Atrial Fibrillation), then the 3-month AAD criteria will not apply.
• One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months.

Exclusion criteria

• Prior typical atrial flutter ablation treatment
• Atypical flutter or scar flutter (non-isthmus dependent)
• Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NHYA Class III or IV) at the time of enrollment
• A recent MI within 3 months of the intended procedure date
• Permanent coronary sinus pacing lead

Principal investigator

D. Randolph Jones, M.D.

Sponsor

St. Jude Medical Inc.

Contact

Heather Aiona, C.C.R.C., clinical research coordinator, at
heather.aiona@providence.org or 503-216-2099.

Inclusion criteria

• Patients with CHF for >3 months, and NYHA class II, III, or IV
• EF <40%
• Hemoglobin must be between: 9.0 g/dL-12.0 g/dL

Exclusion criteria

• B12 or Folate below lower limit of normal
• Tsat is <15%
• CHF is primarily due to valvular disease

Principal investigator

Ranae Ratkovec, M.D.

Sponsor

Amgen Pharmaceuticals

Contact

Michelle Dixon, C.C.R.C., clinical research coordinator, at
michelle.dixon@providence.org or 503-215-6746.

Inclusion criteria

• Patients with CHF (new or previous)
• EF >45%
• BNP >100 pg/ml OR hospitalized in last 12 months with CHF

Exclusion criteria

• Serum Potassium >5.0 mmol/L
• MI in past 90 days
• Significant chronic pulmonary disease

Principal investigator

Ranae Ratkovec, M.D.

Sponsor

National Heart, Lung and Blood Institute, which is part of the NIH

Contact

Michelle Dixon, C.C.R.C., clinical research coordinator, at
michelle.dixon@providence.org or 503-215-6746.

Enrollment criteria

• Symptomatic patients with >50% carotid artery stenosis OR
• Asymptomatic patients with >80% carotid artery stenosis AND
• One or more of the following risk factors:
• • Congestive heart failure and/or known severe left ventricular dysfunction LVEF <35%
  • Open-heart surgery within six weeks
  • Recent MI (>24 hours and <6 weeks)
  • Unstable angina
  • Synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization
  • Requirement for simultaneous or staged cardiac valve surgery, peripheral vascular surgery, or AAA repair within 60 days
  • Severe pulmonary disease
  • Contralateral carotid occlusion
  • Contralateral laryngeal palsy
  • Post-radiation treatment to the neck
  • Previous CEA recurrent stenosis
  • High cervical ICA lesions or CCA lesions below the clavicle
  • Severe tandem lesions
  • Abnormal stress test

Principal investigator

Brad Evans, M.D.

Contact

Cindy Payne L.P.N., cardiovascular research coordinator,
The Oregon Clinic; at cpayne@orclinic.com or 503-963-2946.

The CAPTURE-2 Post Market Study is an observational study to collect safety data on patients receiving carotid stents. Patients will be administered a brief neurologic exam (NIH Stroke Scale) before their carotid procedure, 24-hour post-procedure, and at a 30-day office visit.

Enrollment criteria

• Symptomatic patients with >50% carotid artery stenosis OR
• Asymptomatic patients with >80% carotid artery stenosis

Principal investigator

Brad Evans, M.D.

Contact

Cindy Payne L.P.N., cardiovascular research coordinator,
The Oregon Clinic; at cpayne@orclinic.com or 503-963-2946.

This is a prospective, multi-center, non-randomized study of the SilverHawk device in the treatment of atherosclerotic femoropopliteal and tibial-peroneal arteries. The objective of this study is to evaluate the intermediate and long-term effectiveness of stand-alone SIlverHawk device for endovascular treatment of peripheral arterial disease in these arteries.

The SilverHawk device is cleared for commercial use by the FDA. Follow-up assessments occur at pre-discharge, 30 days, three months (subjects who are classified at baseline as Rutherford 5 or 6 only), six months, and one year post-study procedure.

Principal investigator

Naveen Sachdev, M.D.

Sponsor

ev3 Endovascular Inc.

Contact

Ellen Muir, C.C.R.C., clinical research coordinator, at
ellen.muir@providence.org or 503-216-2110

Inclusion criteria

1. Subjects for treatment must have patent superficial femoral and popliteal arteries on the treatment side(s) with at least one patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) that provides in-line circulation to the lower leg and foot as confirmed by arteriography. Patent is defined as <50% stenosis.
2. This trial allows the treatment of a maximum of two bilateral de novo or restenotic (prior PTA) atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side). If a target lesion is within an iliac artery that has been previously stented, that subject may not be enrolled in the clinical trial.
3. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).

Exclusion criteria

1. Subject is unable to walk.
2. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5 or 6.
3. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).
4. Subject has uncontrolled diabetes mellitus (DM) (serum glucose >400 mg/dl).

Principal investigator

Ethan Korngold, M.D.

Sponsor

Abbott Vascular

Contact

Ellen Muir, C.C.R.C., clinical research coordinator, at
ellen.muir@providence.org or 503-216-2110

Investigator

John Roll, M.D.

Device sponsor/manufacturer

CODMAN Neurovascular Inc.

Contact

Eric Johnson, C.C.R.C., clinical research supervisor, at
eric.johnson@providence.org or 503-216-2075.

Principal investigator

Kenton Gregory, M.D.

Sponsor

Oregon Medical Laser Center

Contact

Eric Johnson, C.C.R.C., clinical research supervisor, at
eric.johnson@providence.org or 503-216-2075.

Inclusion criteria

• Patients with one or two de novo lesions each in a different epicardial vessel
• Must have TIMI flow of 1 and diameter stenosis =50% and <100%

Exclusion criteria

• MI with enzymes still elevated
• LVEF <30%
• TIA/CVA in past 6 months
• On chronic anticoagulation therapy (Coumadin or heparin)

Principal investigator

Todd Caulfield, M.D.

Sponsor

Abbott Vascular

Contact

Ellen Muir, C.C.R.C., clinical research coordinator, at
ellen.muir@providence.org or 503-216-2110.

Principal investigator

Todd Caulfield, M.D.

Sponsor

Boston Scientific Corp.

Principal investigator

Todd Caulfield, M.D.

Sponsor

Boston Scientific Corp.

Principal investigator

Todd Caulfield, M.D.

Sponsor

Guidant Corp./Abbott Vascular Inc.

Principal investigator

Todd Caulfield, M.D.

Sponsor

Abbott Vascular Inc.

Principal investigators

Jeffrey Swanson, M.D., E. Charles Douville, M.D.

Sponsor

St. Jude Medical S.C., Inc.

Principal investigator

Jeffrey Swanson, M.D.