Clinical Research

 

ResearchBasic science and clinical investigation has dramatically contributed to medical knowledge in recent decades. The contemporary practice of medicine remains critically dependent upon the results of ongoing scientific research. One of the best ways to fully understand and to maintain access to cutting-edge medical therapeutics is to participate in research trials as a clinical investigator.

Ventura Cardiology has a long tradition of participation in national and international clinical research trials. We have been a leading contributor to some of the most influential trials conducted in the past decade. The trials in which we have participated have been presented at international conferences and published in the world’s premier medical journals, and the results are now incorporated as clinical practice standards. Our research department includes experienced personnel who attend to the countless details that are required to produce pure scientific data. All of our cardiologists remain fully active as principal investigators or sub-investigators in all ongoing trials.


Completed Research Trials:

ORBIT-AF: Ortho-McNeil Janssen Scientific Affairs.
The ORBIT-AF registry will be a multicenter, prospective outpatient disease registry to identify "real world" treatment patterns of atrial fibrillation. The registry will describe this patient population with regards to demographics, clinical factors, risk stratification, and geographic regions. In particular, attention will be focused on the utilization, effectiveness, and safety of antithrombotic therapies in the prevention of stroke. The registry is designed to identify reasons and risk factors for non-receipt of anticoagulation (AC) therapy, as well as reasons why AF patients who are prescribed AC therapy do not take them.
http://clinicaltrials.gov/ct2/show/NCT01165710

IMPROVE-IT: Schering-Plough.
A multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin (ezetimibe/simvastatin tablet) versus simvastatin monotherapy in high-risk subjects presenting with acute coronary syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT).
http://clinicaltrials.gov/ct2/show/NCT00202878

ROCKET- AF: Bayer.
Evaluation of the efficacy and safety of rivaroxaban (BAY 59-7939) for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation.
http://clinicaltrials.gov/ct2/show/NCT00494871

ASCEND-HF: Scios.
Double-blind, placebo-controlled, multicenter acute study of clinical effectiveness of nesiritide in subjects with decompensated heart failure.
http://clinicaltrials.gov/ct2/show/NCT00475852

CURRENT: Sanofi-Aventis.
Randomized, multinational, double-blind study comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy.

EFC6911: Sanofi-Aventis.
A multicenter, randomized, placebo-controlled, factorial design, 12-month study to evaluate the efficacy and safety of AVE5530 25 mg/day and 50 mg/day co-administered with all registered atorvastatin strengths ranging from 10 mg to 80 mg in patients with primary hypercholesterolemia.

COGENT-1: Cogentus Pharmaceuticals, Inc.
A randomized, double blind, double-dummy, parallel group, phase 3 efficacy and safety study of CGT-2168 compared with clopidogrel to reduce upper gastrointestinal events including bleeding and symptomatic ulcer disease.

ACCELA: Sanofi-Aventis.
A randomized, double-blind, placebo-controlled, parallel group trial of HMR 1766 assessing the efficacy and safety of 3 doses of HMR 1766 (25mg, 100 mg, 200 mg QD) versus placebo with cilostazol 100 mg BID as a calibrator, administered for 26 weeks in patients with peripheral arterial disease (PAD) Fontaine stage II.

ATHENA: Sanofi-Aventis.
A placebo-controlled, double-blind, parallel arm trial to asses the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation / atrial flutter.

STEEPLE: Aventis.
Safety and efficacy of enoxaparin in percutaneous coronary intervention patients: An international randomized evaluation.

EARLY ACS: Millenium.
Early glycoprotein IIb/IIIa inhibition in non-ST segment elevation acute coronary syndrome: A randomized, placebo-controlled trial evaluating the clinical benefits of early front-loaded eptifibatide in the treatment of patients with non-ST segment elevation acute coronary syndrome.

JUPITER: Astra-Zenica.
Randomized, placebo-controlled study of Crestor in primary prevention of cardiovascular events among subjects with low LDL-cholesterol and elevated C-reactive protein.

PROTOCOL 21-98-214-01: Otsuka.
Randomized, placebo-controlled study to assess the long-term effects of Pletal in patients with intermittent claudication secondary to peripheral arterial disease.

SYNERGY: Aventis.
A prospective, randomized, open label multicenter study in patients with acute coronary syndromes: Enoxaparin versus heparin.

Trap 2 P - TIMI 50: Schering-Plough.
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SCH 530348 in addition to standard of care in subjects with a history of atherosclerotic disease: Thrombin receptor antagonist in secondary prevention of atherothrombotic ischemic events.
http://clinicaltrials.gov/ct2/show/study/NCT00526474

ARISTOTLE: Bristol-Myers Squibb.
A phase 3, active (warfarin) controlled, randomized, double-blind, parallel arm study to evaluate efficacy and safety of apixaban in preventing stroke and systemic embolism in subjects with non-valvular atrial fibrillation.
http://clinicaltrials.gov/ct2/show/NCT00412984


Current Research Trials:

ixCELL DCM.
Multicenter, Randomized Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the efficacy, safety and tolerability of Transendocardial injection of Ixmyelocel-T in subjects with heart failure due to ischemic dilated cardiomyopathy (IDCM).
http://clinicaltrials.gov/ct2/show/NCT01670981?term=nct01670981&rank=1

CAMELLIA-TIMI 61: Eisai & Arena Pharmaceuticals.
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
http://clinicaltrials.gov/ct2/show/NCT02019264?term=camellia&rank=5

TIGRIS: AstraZeneca.
Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients
http://clinicaltrials.gov/ct2/show/NCT01866904?term=tigris&rank=1

ORBIT-AF II: Janssen Scientific Affairs, LLC.
The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, prospective outpatient disease registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a broad and contemporary view of AF therapy.
http://clinicaltrials.gov/ct2/show/NCT01701817?term=orbit+af+II&rank=1

PEGASUS: AstraZeneca.
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction
http://clinicaltrials.gov/ct2/show/NCT01225562

REDUCE-IT: InVentive Health Care.
Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial).
http://clinicaltrials.gov/ct2/show/NCT01492361?term=reduce+it&rank=1

GLORIA-AF: Boehringer Ingelheim.
Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III).
http://clinicaltrials.gov/ct2/show/NCT01468701?term=gloria+af&rank=2

DECLARE TIMI 58: AstraZeneca.
Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes.
http://clinicaltrials.gov/ct2/show/NCT01730534?term=declare&rank=2