Clinical trials: High Cardiovascular Risk Patients
Hypercholesterolemia
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24…
- Trial name
- ODYSSEY EAST (NCT02715726)
- Testing
- Alirocumab, ezetimibe, atorvastatin
- Where
- 62 sites in China, India and 1 more
- Volunteers
- 615 people
- Sponsor
- Sanofi
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
- Trial name
- NCT01644175
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 76 sites in United States
- Volunteers
- 316 people
- Sponsor
- Sanofi
Heart Failure, Congestive
FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR (Nesiritide) Administered to Patients With Worsening Congestive (Decompensated) Heart Failure Who Are Concurrently Receiving Their Usual Cardiac Medications and Are at High Risk for Hospitalization.
The purpose of this study is to assess the safety and tolerability of two doses of nesiritide (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) when administered…
- Trial name
- NCT00270361
- Testing
- nesiritide, usual long term cardiac medications
- Volunteers
- 214 people
- Sponsor
- Scios, Inc.
Hypercholesterolemia, Coronary Heart Disease
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular…
- Conditions
- Hypercholesterolemia, Coronary Heart Disease, Peripheral Vascular Disease, CVA
- Trial name
- CHALLENGE (NCT00574782)
- Volunteers
- 2,660 people
- Sponsor
- AstraZeneca
Hypertension
Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension
A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.
- Trial name
- ACCOMPLISH (NCT00170950)
- Testing
- Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1, Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2, Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter
- Where
- 5 sites in United States, Denmark and 3 more
- Volunteers
- 11,506 people
- Sponsor
- Novartis
Coronary Artery Disease
On Versus Off Pump Myocardial Revascularization Study
Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery.
- Trial name
- On-Off (NCT01290952)
- Testing
- Off-pump bypass surgery, On-pump bypass surgery
- Where
- 8 sites in Italy, Switzerland
- Volunteers
- 411 people
- Sponsor
- Medtronic Italia
Carotid Artery Diseases
A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach
The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures…
- Trial name
- NCT06653387
- Testing
- CGuard Prime 80cm stent system
- Where
- 8 sites in United States
- Volunteers
- 50 people
- Sponsor
- InspireMD
Cardiovascular Diseases
A Study of Evacetrapib in High-Risk Vascular Disease
The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).
- Trial name
- ACCELERATE (NCT01687998)
- Testing
- Evacetrapib
- Where
- 444 sites in United States, Argentina and 35 more
- Volunteers
- 12,092 people
- Sponsor
- Eli Lilly and Company
Hypercholesterolemia
A Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia
This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .
- Trial name
- NCT04358432
- Testing
- AK102, Statins and/or Ezetimibe
- Where
- 2 sites in China
- Volunteers
- 262 people
- Sponsor
- Akeso
Hypercholesterolemia, Mixed Dyslipidemia
SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI®
In this study, a survey of office-based cardiologists and lipid management specialists will be conducted on treatment decisions for NUSTENDI® (bempedoic acid 180 mg fixed dose combination [FDC] with ezetimibe 10 mg) followed by a…
- Trial name
- NCT05546398
- Testing
- Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab, No study drug
- Where
- 63 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Elevated Cardiac Risk, Coronary Arteries Disease Risk
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with…
- Trial name
- CARVASAXe (NCT01120405)
- Testing
- Xenon, Sevoflurane
- Where
- 13 sites in France
- Volunteers
- 600 people
- Sponsor
- Air Liquide Santé International
Multiple Myeloma
Descartes-11 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-11 in patients with high-risk myeloma who have residual disease following induction therapy.
- Trial name
- NCT04436029
- Testing
- Descartes 11
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Cartesian Therapeutics
Cardiac Death, Myocardial Infarction
Leaders Free III: BioFreedom™ Clinical Trial
A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding
- Conditions
- Cardiac Death, Myocardial Infarction, Stent Thrombosis, Bleeding
- Trial name
- NCT03118895
- Testing
- BioFreedom™ BA9™ drug-coated stent
- Where
- 2 sites in France, Switzerland
- Volunteers
- 404 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease, High Bleeding Risk Patients
PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon
The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.
- Trial name
- PaneLux PTCA (NCT01930903)
- Testing
- Pantera Lux Drug Eluting Balloon
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Biotronik France
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 people
- Sponsor
- Biosense Webster, Inc.
Heart Failure
Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing
The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.
- Trial name
- LMI1195-201 (NCT01085175)
- Testing
- LMI 1195
- Where
- United States
- Sponsor
- Lantheus Medical Imaging
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
Angina, Unstable, Myocardial Infarction
Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery)
- Trial name
- NCT00435487
- Testing
- Dalteparin ( Fragmin), Unfractionated heparin
- Where
- 8 sites in India
- Volunteers
- 173 people
- Sponsor
- Pfizer
Coronary Artery Disease
An Open-label, Non-comparative Study to Document the Tolerability to Ramipril in Patients With at Least One High Risk for Developing a Major Cardiovascular Event
Primary Objective: To document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator.
- Trial name
- HOPETips (NCT03099213)
- Testing
- RAMIPRIL HOE498
- Where
- Indonesia
- Volunteers
- 179 people
- Sponsor
- Sanofi