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Research Studies
July 2008 (revised 7.14.08) | Study Type | Acute Coronary Syndrome | | Title | Appraise-Apixaban for Prevention of Acute Ischemic Safety Events | | Study Aim | Evaluate safety (bleeding) of 4 doses of apixaban as compared to placebo over a 26 week treatment period in selected subjects with recent (< 7 days) ACS. Determine optimal dose and regimen of apixaban for use in Phase 3 ACS trial. | | Study Type | Acute Coronary Syndrome | | Title | Avant Garde-To Evaluate the Efficacy of Aliskiren and Valsartan Versus Placeboon Lowering Levels of NT-proBNP in Stabilized Patients Post-ACS. | | Study Aim | Determine whether aliskiren reduces the levels of NT-proBNP from baseline to week 8 as compared to placebo. Second objective is to determine whether the combination of aliskiren and valsartan reduces the levels of NT-proBNP from baseline to week 8 as compared to each individual monotherapy and placebo. | | Study Type | Acute Coronary Syndrome | | Title | Improve It-Improved Reduction of Outcomes: Vytorin Efficacy International Trial | | Study Aim | Establish the clinical benefit of Vytorin (Ezetimibe/Simvastatin tablet) versus Simvastatin monotherapy in high-risk subjects presenting with Acute Coronary Syndrome. | | Study Type | Acute Coronary Syndrome-Unstable Angina and non-ST Elevation MI | | Title | Current-Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent Events/Optimal Antiplatelet Strategy for Interventions | | Study Aim | Determine whether a high dose regimen of clopidogrel (600 mg loading dose followed by 150 mg once daily from day 2 to 7, then 75 mg daily) in preventing the composite of cardiovascular death, MI or stoke and/or the composite of cardiovascular death, MI, recurrent ischemia or stroke in patients with non-ST segment ACS who are treated with an early invasive strategy with the intent to perform PCI as early as possible within 24 hours of randomization. | | Study Type | Arthritis and Coronary Vascular Disease | | Title | Precision-Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naprosyn | | Study Aim | Compare the effects of the Cox-2-selective inhibitor Celebrex with those of the traditional NSAIDs (ibuprofen and naproxyn) on CV events in patients with osteoarthritis or rheumatoid arthritis who have or are at high risk for CVD. | | Study Type | Atrial Fibrillation | | Title | Omacor-Assess the Efficacy and Safety of Omacor® for the Prevention of Recurrent, Symptomatic Atrial Fibrillation | | Study Aim | Assess the effect of Omacor® (Omega-3-acid ethyl esters) on time to first symptomatic recurrence of atrial fibrillation in subjects with paroxysmal atrial fibrillation. Time will be measured as event-free days from the first dose of study drug to the first symptomatic recurrence of atrial fibrillation. | | Study Type | Atrial Fibrillation | | Title | Rocket-Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) with Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Embolism in Subjects with Non-Valvular Atrial Fibrillation | | Study Aim | Demonstrate that the efficacy or rivaroxaban, a direct Fxa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial fibrillation as measured by the composite of stroke and non-central nervous system systemic embolism. | | Study Type | Coronary Artery Bypass | | Title | Glutamine- Effect of glutamine on heat shock protein expression and metabolic state in human myocardial tissue | | Study Aim | Pre-operative glutamine therapy will attenuate myocardial injury during CABG as measured by coronary effluent and plasma troponin and creatinine phosphokinase release. | | Study Type | Device Registry | | Title | Optimum-Optim™ Lead Insulation Material Registry | | Study Aim | Produce a prospective, outcome-oriented registry of patients implanted with SJM Optim™ leads. This registry will evaluate the chronic clinical performance of the market-released SJM Cardiac Rhythm Management (CRM) leads with Optim™ insulation material. | | Study Type | Device study (ICD) | | Title | Right-Rhythm ID Going Head-to-head Trial | | Study Aim | Assess VT/VF arrhythmia discrimination in Guidant (Rhythm ID™) versus Medtronic (Enhanced PR Logic™ and Wavelet™) ICDs by comparing the time to first inappropriate VT/VF therapy after the pre-discharge visit. Inappropriate VT/VF therapy is defined as a VT/VF therapy delivered for a SVT event. | | Study Type | PACEMAKER | | Title | PACEmakers and Beta-blocker Therapy after Myocardial Infarction (PACE-MI) | | Study Aim | Investigate whether pacemaker facilitated beta-blocker therapy after MI reduces the combined endpoint of total mortality & non-fatal reinfarction in a subgroup of post MI patients who currently do not routinely receive beta-blocker therapy. | | Study Type | Patent Foramen Ovale and Crytogenic Stroke | | Title | RESPECT-Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment | | Study Aim | Investigate whether percutaneous PFO closure is superior to current standard of care (medical treatment) in the prevention of recurrent embolic stroke or transient ischemic attacks as evaluated by: non-fatal stroke, periprocedural death and fatal stroke. | | Study Type | Patent Foramen Ovale Closure and Recurrent Stroke Registry | | Title | PFO Access Registry–Patent Foramen Ovale Closure with the Amplatzer PFO Occluder Device in Patients with Recurrent Cryptogenic Stroke Due to Presumed Paradoxical Embolism through a Patent Foramen Ovale Who Have Failed Conventional Drug Therapy | | Study Aim | Allow access to the Amplatzer PFO Occluder device in subjects with a PFO who have already experienced at least 2 cryptogenic strokes due to presumed paradoxical embolism through patent foramen ovale and who have failed conventional drug therapy. Information from this registry may be considered as supportive in conjunction with data from ongoing RESPECT randomized clinical trial. |
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