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Completed Clinical Trials Conducted by VHIF

Trial Name

Description of Trial

GUSTO-IV

Placebo-controlled trial evaluating the efficacy and safety of ReoPro™, given as a bolus followed by a 24- or 48- hour infusion, for the treatment of acute coronary syndrome without ST-segment elevation.

GUSTO-IV AMI

A phase III, randomized, open-label trial evaluating the efficacy and safety of ReoPro (ABCIXMAB) in combination with reduced dose retavase/rapilysin (recombinant plasminogen activator, retaplase, r-PA) for the treatment of acute myocardial infarction.

HARMONY OUTCOMES

A long term, randomized, double-blind, placebo-controlled study to determine the effect of albiglutide, when added to standard glood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes mellitus.

HEART FID

A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of (ferric carboxymaltose) as treatment for HF with iron deficiency.

HERITAGE (CTQJ230A12301)

Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein (a) among subjects with establisedh cardiovascular disease.

ILUMIEN IV

OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI.

IMAGINE

Ischemia management with accupril post bypass graft via inhibition of converting enzyme: An evaluation of the effect of 12 to approximately 24 months treatment with quinapril 40 mg QD post CABG surgery on ischemic events.

IMPROVE-IT A mult-centered, double-blind, randomized study to establish the clinical benefit and safety of vytorin/esetimimbe/simvastatin vs. simvastatin monotherapy in high risk patients presenting with acute coronary sydrome.

INTIME-II

Single-bolus lanoteplase versus accelerated alteplase for the treatment of subjects with acute myocardial infarction.

INTIME-IIB

Trial of single-bolus lanoteplase for the treatment of subjects with acute myocardial infarction.

INVESTED Influenza vaccine to effectively stop cardio thoracic events decompensated heart failure.

JUMBO-TIMI 26

A double-blind, randomized, multicenter, dose-ranging, trial of CS-747 (LY640315), compared with clopidogrel in patients undergoing percutaneous coronary intervention.

LAAOS III

Left atrial appendage occlusion study III.

LATITUDE-TIMI 60

A clinical outcomes study to compare the incidence of major adverse cardiovascular events in subjects presenting with acute coronary syndrome treated with losmapimod compared to placebo.

LEADERS FREE II

A prospective study of the BioFreedom Biolimus A9 drug coated stend in patients at high risk for bleeding.

LEVO-CTS

A double-blind, randomized, placebo-controlled study of levosimendan in patients with left ventricular dysfunction undergoing cardiac surgery requiring cardiopulmonary bypass.

MACH 1- RO 40

The effect of RO-40/5967 on all cause mortality in comparison with placebo in patients with chronic heart failure.

MEND-CABG II Cardioprotective effects of MC-I in patients undergoing high-risk coronary artery bypass graft (CABG) surgery.
MERLIN Ranolazine versus placebo in patients with non-ST segment elevation acute coronary syndromes.
MINT National Institutes of Health (NIH) Myocardial Ischemia and Transfusion: The Mint Trial.
OCEANIC-AF

.
A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke.
ODYSSEY OUTCOMES A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of SAR236553/REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an acute coronary syndrome.

OPUS-TIMI 16 .

To evaluate the efficacy and safety of orbofiban in patients with unstable coronary syndromes.

OVERTURE

Omapatrilat versus enalapril randomized trial of utility in reducing events phase III study.

PARADIGM-HF A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction.
PARADISE-MI A multi-center, randomized, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction.
PARAGLIDE-HF

A multi-center, randomized, double-blind, double-dummy, parallel group, active controlled study to evaluate the effect of sacubitril/valsartan (LCZ696) versus valsartan on changes in NT-proBNP and outcomes, safety and tolerability in HFpEF patients with acute decompensated heart failure (ADHF) who have been stabilized during hospitalization and initated in-hopsital or within 30 days post-discharge.

PARAGON-HF A multicenter, randomized, double-blind, parallel-group, acative controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction.
PEGASUS TIMI 54
Randomized, double-blind trial to assess the prevention of thrombotic events with tigagrelor compared to placebo on a background of ASA in patients with a history of MI.
PERISCOPE A double-blind, randomized, comparator-controlled study in subjects with Type II diabetes mellitus comparing the effects of pioglitazone HCL versus glimepiride on the rate of progression of coronary atherosclerotic disease as measured by intravascular ultrasound.
PIONEER AF-PCI An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral Vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo PCI.
PLATO
AZD6140 compared with clopidogrel for prevention of vascular events in patients with Non-ST or ST elevation ACS.

PRAISE-2

Prospective Randomized Amlodipine Survival Evaluation-2.

PREMIER

A multi-centre, randomized, double-blind, parallel-group, placebo-controlled study of a 200 mg oral dose of PG-116800 given as the sodium salt (PG-530742) twice daily for 90 days to patients following acute myocardial infarction, with post-treatment follow-up.

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