Clinical trials: High Cardiovascular Risk
Hypercholesterolemia
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to…
- Trial name
- NCT02476006
- Testing
- ALIROCUMAB SAR236553 (REGN727), ezetimibe, atorvastatin
- Where
- 153 sites in Austria, Belgium and 14 more
- Volunteers
- 998 people
- Sponsor
- Sanofi
Multiple Myeloma
Pembrolizumab + Lenalidomide Post Autologous Stem Cell Transplant (ASCT) in High-risk Multiple Myeloma (MM)
This is an open-label, Phase II, single center trial of pembrolizumab (MK-3475), lenalidomide and dexamethasone in subjects with high risk Multiple Myeloma (hrMM) post high-dose chemotherapy with autologous stem cell…
- Trial name
- NCT02906332
- Testing
- Pembrolizumab, Lenalidomide, Dexamethasone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Hackensack Meridian Health
Sick Sinus Syndrome, Complete Heart Block
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or…
- Conditions
- Sick Sinus Syndrome, Complete Heart Block, Syncope, Chronic Systolic Heart Failure
- Trial name
- ENVELOPE (NCT02809131)
- Testing
- polymixin/bacitracin, cephalexin, or levofloxacin, or clindamycin, Saline
- Where
- United States
- Volunteers
- 1,010 people
- Sponsor
- Vanderbilt University Medical Center
Diabetic Retinopathy
Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy
This 24 month randomized research study will evaluate whether doxycycline can 1) slow the deterioration or improve retinal function and/or 2) induce regression, or slow progression, of diabetic retinopathy in participants over 18…
- Trial name
- POC1 (NCT00511875)
- Testing
- doxycycline monohydrate
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Thomas Gardner
Hypertension, Ischemic Heart Disease
Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)
The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.
- Conditions
- Hypertension, Ischemic Heart Disease, Congestive Heart Failure, Stroke
- Trial name
- NCT00149227
- Testing
- Valsartan, Non-ARB
- Where
- Japan
- Volunteers
- 3,031 people
- Sponsor
- Kyoto Prefectural University of Medicine
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Hypertension
Telmisartan Tab Hypertension
To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk
- Trial name
- NCT00890084
- Testing
- Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
- Volunteers
- 2,913 people
- Sponsor
- Boehringer Ingelheim
Mild Cognitive Impairment, Alzheimer's Disease
Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
The purpose of this pilot study will be to test whether Kundalini yoga (KY) and Kirtan Kriya (KK) yogic meditation is superior to Memory Enhancement Training (MET) for improving cognitive functioning, health (including…
- Trial name
- NCT03503669
- Testing
- Memory Training, Kundalini yoga and meditation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, Los Angeles
Diabetes Mellitus, Non-Insulin-Dependent
The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
The primary objectives of the ORIGIN study were: To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired…
- Trial name
- ORIGIN (NCT00069784)
- Testing
- insulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), reusable pen device for insulin injection
- Where
- 40 sites in United States, Argentina and 38 more
- Volunteers
- 12,537 people
- Sponsor
- Sanofi
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to…
- Trial name
- STRENGTH (NCT02104817)
- Testing
- Epanova® (omega-3 carboxylic acids), corn oil control
- Where
- 684 sites in United States, Australia and 20 more
- Volunteers
- 13,078 people
- Sponsor
- AstraZeneca
Aortic Valve Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiovascular Diseases
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc.
- Trial name
- REDUCE-IT (NCT01492361)
- Testing
- AMR101, Statin therapy
- Where
- 410 sites in United States, Australia and 9 more
- Volunteers
- 8,179 people
- Sponsor
- Amarin Pharma Inc.
Dyslipidemias, Hypercholesterolemia
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk…
- Conditions
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD
- Trial name
- TANDEM (NCT06005597)
- Testing
- Combination Therapy, Monotherapy obicetrapib, Monotherapy ezetimibe
- Where
- 45 sites in United States
- Volunteers
- 407 people
- Sponsor
- NewAmsterdam Pharma
Multiple Myeloma
Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302)
This study is designed to compare progression-free survival (PFS) from randomization among patients randomized on the BMT CTN 1302 protocol, "Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib…
- Trial name
- NCT02440464
- Testing
- Allogeneic HSCT, Fludarabine, Melphalan
- Where
- 15 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Carotid Artery Stenosis
ViVEXX Carotid Revascularization Trial (VIVA)
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid…
- Trial name
- NCT00417963
- Testing
- Carotid Artery Stenting
- Volunteers
- 407 people
- Sponsor
- C. R. Bard
Myocardial Infarction
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack).
- Trial name
- NCT00414609
- Testing
- Aliskiren
- Where
- 23 sites in United States, Argentina and 21 more
- Volunteers
- 820 people
- Sponsor
- Novartis
Refractory Plasma Cell Myeloma
Autologous or Syngeneic Stem Cell Transplant Followed by Donor Stem Cell Transplant and Bortezomib in Treating Patients With Newly Diagnosed High-Risk, Relapsed, or Refractory Multiple Myeloma
This phase II trial studies the side-effects and anti-cancer effects of giving an autologous or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and bortezomib.
- Trial name
- NCT00793572
- Testing
- Autologous Hematopoietic Stem Cell Transplantation, Bortezomib, Cyclosporine
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fred Hutchinson Cancer Center
Cardiovascular Disease
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and…
- Trial name
- SPIRE-2 (NCT01975389)
- Testing
- bococizumab (PF-04950615)
- Where
- 1,595 sites in United States, Argentina and 33 more
- Volunteers
- 10,564 people
- Sponsor
- Pfizer
Non ST Elevation Myocardial Infarction
Clinical Effects of Eptifibatide Administration in High Risk Patients Presenting With Non-ST Segment Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Urgent Coronary Artery Bypass Graft Surgery in Short- and Long-Term Follow-up
1. INTRODUCTION Through last couple of years the number of patients treated for acute coronary event without persistent ST segment elevation in ECG has been growing.
- Trial name
- NCT01863134
- Testing
- Eptifibatide
- Where
- 6 sites in United States, Poland
- Volunteers
- 140 people
- Sponsor
- Medical University of Silesia
Carotid Artery Disease
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and…
- Trial name
- PROTECT (NCT00402740)
- Testing
- Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
- Where
- 38 sites in United States
- Volunteers
- 322 people
- Sponsor
- Abbott Medical Devices