Clinical trials: Cardiovascular Outcomes
Heart Diseases, Heart Transplantation
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
- Trial name
- NCT00157014
- Testing
- Tacrolimus, Cyclosporine, Mycophenolate mofetil
- Where
- 13 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Astellas Pharma Inc
Adenocarcinoma, Adenocystic Carcinoma
The Registry of Oncology Outcomes Associated With Testing and Treatment
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer
- Trial name
- ROOT (NCT04028479)
- Testing
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Taproot Health
Diabetes Mellitus, Type 2, Acute Myocardial Infarction
Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes
The primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on time until the first combined…
- Trial name
- IONM (NCT00191282)
- Testing
- Insulin lispro, Human insulin isophane suspension (NPH), Insulin glargine
- Where
- 17 sites in Canada, Croatia and 15 more
- Volunteers
- 1,116 people
- Sponsor
- Eli Lilly and Company
AAA, AAA - Abdominal Aortic Aneurysm
JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population.
- Trial name
- NCT05409118
- Testing
- Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems
- Sponsor
- Endologix
Cardiovascular Disease
Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.
- Trial name
- CRESCENDO (NCT00263042)
- Testing
- Rimonabant
- Where
- 43 sites in United States, Argentina and 41 more
- Volunteers
- 18,695 people
- Sponsor
- Sanofi
Heart Failure
A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack.
- Trial name
- EMPHASIS-HF (NCT00232180)
- Testing
- Eplerenone
- Where
- 307 sites in United States, Argentina and 27 more
- Volunteers
- 2,743 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
Registry on WATCHMAN Outcomes in Real-Life Utilization
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism.
- Trial name
- EWOLUTION (NCT01972282)
- Testing
- WATCHMAN Left Atrial Appendage Closure
- Where
- 47 sites in Belgium, France and 11 more
- Volunteers
- 1,025 people
- Sponsor
- Boston Scientific Corporation
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
- Conditions
- Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
- Trial name
- BRAVO 2/3 (NCT01651780)
- Testing
- Bivalirudin, Unfractionated Heparin
- Where
- 33 sites in Canada, France and 5 more
- Volunteers
- 803 people
- Sponsor
- The Medicines Company
Chagas Disease, Heart Failure
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC
The purpose of this study was to evaluate the effect of sacubitril/valsartan 200 mg BID compared with enalapril 10 mg BID, in addition to conventional heart failure (HF) treatment, in improving a hierarchical composite of…
- Trial name
- PARACHUTE-HF (NCT04023227)
- Testing
- Sacubitril/valsartan, Enalapril
- Where
- 79 sites in Argentina, Brazil and 2 more
- Volunteers
- 922 people
- Sponsor
- Novartis Pharmaceuticals
Dyslipidemia, Coronary Heart Disease
Observational Study to Estimate the Rates of Outcomes in Patients Undergoing Percutaneous Coronary Intervention (PCI) With Drug Eluting Stent (DES) Implantation Who Take Statins
To estimate the rates of percutaneous coronary intervention (PCI) outcomes in patients after drug-eluting stents implantation who take statins.
- Trial name
- OPTIMA (NCT01047176)
- Where
- Russia
- Volunteers
- 602 people
- Sponsor
- AstraZeneca
Hypertension, Pulmonary
Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and…
- Trial name
- NCT02191137
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 59 sites in United States, Puerto Rico
- Volunteers
- 75 people
- Sponsor
- Bayer
Nonfatal Myocardial Infarction, Coronary Death
Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Death
The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and…
- Trial name
- NCT01360047
- Where
- Spain
- Volunteers
- 39,513 people
- Sponsor
- AstraZeneca
Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection…
- Trial name
- Elevate-HF (NCT07761117)
- Testing
- Elecoglipron
- Where
- 679 sites in United States, Argentina and 30 more
- Volunteers
- 6,950 people
- Sponsor
- AstraZeneca
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
Atrial Fibrillation, Paroxysmal Arrhythmia
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
- Trial name
- SFAF (NCT01585961)
- Testing
- Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
- Where
- 45 sites in United States
- Volunteers
- 511 people
- Sponsor
- Biosense Webster, Inc.
Diabetes Mellitus, Type 2
A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
- Trial name
- THEMIS (NCT01991795)
- Testing
- Ticagrelor 60 mg
- Where
- 1,237 sites in United States, Argentina and 41 more
- Volunteers
- 19,271 people
- Sponsor
- AstraZeneca
Abdominal Aortic Aneurysm
Nellix Registry Study: EVAS-Global
Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System.
- Trial name
- EVAS FORWARD 2 (NCT02996396)
- Testing
- Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
- Where
- 10 sites in Germany, Netherlands and 2 more
- Volunteers
- 48 people
- Sponsor
- Endologix
Venous Leg Ulcer (VLU)
Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes
The investigators are conducting a study to find out if a new system can help improve the care of people with venous leg ulcers (VLU).
- Trial name
- NCT07268482
- Testing
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- Feeltect Limited
Ventricular Tachycardia, Premature Ventricular Contraction
RMN Versus Manual Epicardial Retrospective PMCF
Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or…
- Trial name
- EPINAV (NCT04171479)
- Testing
- Epicardial mapping and/or ablation
- Where
- 3 sites in Czechia, Netherlands
- Volunteers
- 40 people
- Sponsor
- Stereotaxis
Rheumatoid Arthritis
A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA).
- Trial name
- NCT01331837
- Testing
- Etanercept, Tocilizumab
- Where
- 428 sites in United States, Argentina and 29 more
- Volunteers
- 3,080 people
- Sponsor
- Hoffmann-La Roche