Rethinking Clinical Trials

JULY 12, 2023

Neha Pagidipati In this Friday’s PCT Grand Rounds, Christopher Granger and Neha Pagidipati of Duke University will present “Lessons From the COORDINATE-Diabetes Trial.” The post July 12, 2023: In This Week’s PCT Grand Rounds, Lessons From the COORDINATE-Diabetes Trial appeared first on Rethinking Clinical Trials.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Pharmaceutical Technology

JUNE 21, 2023

The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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XTalks

FEBRUARY 6, 2024

Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinical trials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of Clinical Trial Management.

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Rethinking Clinical Trials

NOVEMBER 22, 2022

A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). Results of the study were published in JAMA Cardiology. Read the full report in JAMA Cardiology.

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Clinical Trial Podcast

JULY 31, 2024

Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY. Sponsor(s): This podcast is brought to you by Florence Healthcare.

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Rethinking Clinical Trials

JANUARY 23, 2024

Similar to most types of trials, there are pros and cons to both pragmatic and explanatory designs in imaging trials. RCT design will vary depending on which CAD manifestation(s) are reflected in the information provided by the imaging test being studied, which affects the treatment target(s) being evaluated in a therapeutic trial.

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CTTI (Clinical Trials Transformation Initiative)

DECEMBER 21, 2022

It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies. The post It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies appeared first on CTTI.

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Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The trial took place at 64 sites, and randomized 863 patients. Learn more Read about the PROACT Xa study.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Department of Cardiology. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease.

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Velocity Clinical Research

OCTOBER 12, 2023

Velocity is proud to unveil another groundbreaking initiative: the Cardiology Council to Accelerate Research Excellence (CARE). The proliferation of heart issues — paired with patient lifestyle factors that complicate recruitment and study design — reflect an urgent need for expert-led clinical trials.

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XTalks

NOVEMBER 22, 2024

NewAmsterdam Pharma announced promising results from its Phase III TANDEM clinical trial, evaluating a fixed-dose combination of obicetrapib and ezetimibe. The TANDEM trial enrolled 407 participants with baseline LDL-C levels averaging 97 mg/dL despite maximally tolerated statin use in 74 percent of patients.

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Rethinking Clinical Trials

OCTOBER 24, 2023

REMAP-CAP is an adaptive platform trial simultaneously evaluation multiple treatments in domains using a master protocol. In adaptive trials, trial design features are modified during the trial to maximize statistical efficiency or achieve better patient outcomes. The approach definitely generated evidence more quickly.

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pharmaphorum

APRIL 25, 2022

An analysis of 10 clinical trials of digital health interventions targeted at patients recently hospitalised for acute heart failure has found they improve outcomes compared to standard care. Patients in the digital arms also lost fewer days due to hospitalisation for heart failure – 1.77 days compared to 3.06

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Rethinking Clinical Trials

JULY 19, 2023

However, these therapies are highly underused in routine clinical practice. The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies.

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XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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Medical Xpress

APRIL 21, 2023

More than 70 people presenting at Singapore General Hospital's emergency room with chest pain have been recruited to a new randomized controlled trial of a novel AI-based cardiac risk stratification tool that can rapidly and in real-time identify people whose chest pain is a sign of more serious trouble.

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Medical Xpress

FEBRUARY 21, 2023

Minority ethnicities and regions derive at least as much cardiovascular benefit from lipid-lowering therapies as majority groups despite being underrepresented in clinical trials, according to a study published today in the European Journal of Preventive Cardiology.

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STAT News

JANUARY 6, 2023

The company said it would “externalize” most of its early-stage rare disease programs in neurology and cardiology, and gene therapy programs not yet in clinical trials. Among the assets on the chopping block is a gene therapy manufacturing facility in Durham, N.C.,

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STAT News

AUGUST 3, 2022

Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said Wednesday, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales.

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Rethinking Clinical Trials

FEBRUARY 14, 2024

DCP learned that leveraging health systems for large-scale clinical trials is feasible. How long did the start up for the trial take? Other key success factors were the creative thinking across the study team and the excellent study coordination and partnership within the health system. The actual startup was about 18 months.

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Scienmag

AUGUST 16, 2020

Analysis lead by Penn Medicine identified gender disparities in authorship of heart failure guideline citations and clinical trials PHILADELPHIA– While about a quarter of physicians and researchers working in advanced heart failure (HF) and transplant cardiology are women, representation of women leading HF research remains limited, according (..)

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Scienmag

OCTOBER 15, 2020

Randomized trial studies device designed to reduce embolic events in patients undergoing TAVR NEW YORK – October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of a device designed to reduce cerebral embolization and ischemic stroke, complications of transcatheter aortic valve replacement (TAVR), (..)

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Scienmag

DECEMBER 3, 2020

In a randomized, controlled clinical trial, researchers found that patients who received genetic test results about the side effects of cholesterol-lowering medications did not have worse outcomes after one year A person’s genetic make-up can influence whether they might experience side effects from certain medications.

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XTalks

OCTOBER 25, 2024

Abbott has announced the commencement of a new clinical trial for its advanced left ventricular assist device (LVAD), the HeartMate 3, to determine the benefits of early implantation of the device in patients with advanced heart failure. The device tracks PAP changes over time.

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FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

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BioTech 365

OCTOBER 2, 2020

–(BUSINESS WIRE)–The Journal of the American College of Cardiology published results of the Phase III GadaCAD 1 and GadaCAD 2 clinical trials for … Continue reading → Coronary artery disease (CAD) is a critical public health issue, affecting an estimated 16.5 million Americans1 WHIPPANY, N.J.–(BUSINESS

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The Pharma Data

NOVEMBER 12, 2020

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). About the Company: PQ Bypass, Inc.

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Rethinking Clinical Trials

APRIL 13, 2023

The PRESCRIBE trial revealed the value of active choice as well as peer decision-making to prompt decision-making. Discussion Themes – In the last few years, there has been great reception to the value of behavioral science and implementation science in the field of cardiology.

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pharmaphorum

OCTOBER 2, 2020

The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. How the centres will provide quicker and easier clinical studies.

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Scienmag

OCTOBER 19, 2020

Randomized clinical trial finds no mortality risk or benefit associated with drug-coated devices in the treatment of peripheral artery disease NEW YORK – October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) (..)

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XTalks

JULY 7, 2023

a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinical trial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone Pharmaceuticals Inc.,

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XTalks

SEPTEMBER 4, 2024

Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinical trial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). While HELIOS-A focused on nerve damage, HELIOS-B expands vutrisiran’s use to cardiomyopathy.

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Trialfacts

DECEMBER 5, 2022

It is involved in and leading in many clinical trials for Type 1 and Type 2 Trials both investigator initiated and sponsor lead trials. Consisting of Nephrology and Cardiology, we are dedicated and hardworking teams. Specialising in all phases of clinical trials regarding heart and kidney disease.

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Medical Xpress

MAY 2, 2023

In patients with chronic limb threatening ischemia (CLTI) due to atherosclerosis affecting the arteries below the knee, data from the first clinical trial of its kind shows that a best endovascular treatment first revascularization strategy was more likely to prevent major amputation and death than a vein bypass first strategy.

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Scienmag

AUGUST 31, 2020

EXPLORER-HCM trial presented in a Hot Line Session today at ESC Congress 2020 Sophia Antipolis, France – 29 Aug 2020: Mavacamten improves heart function and symptoms in patients with obstructive hypertrophic cardiomyopathy, according to results of the EXPLORER-HCM trial presented in a Hot Line session today at ESC Congress 2020.1 “The results (..)

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