Alecardio

The extensive global reach of Julius Clinical is demonstrated well by the ALECARDIO trial. The aim of the trial was to determine the effect of treatment with aleglitazar on cardiovascular mortality and morbidity (defined as non-fatal myocardial infarction or stroke) in patients with type 2 diabetes who experienced a recent acute coronary syndrome (ACS) event.

Therapeutic areas

Total patients

7000

Total sites

586

Status

Finished

Overall, about 7,000 patients were recruited at 705 sites in 26 countries in Europe, Northern America, Latin America, Asia Pacific, and Australia/New Zealand. Julius Clinical and its network of local partners were responsible for recruiting most of the patients required for the study. 

Services

Project Management

In this study, Julius Clinical’s Project Director was overall responsible for the project execution (timelines, budget, scope and quality) with a specific focus on planning and management based on metrics. Our training department was responsible for the overview, execution and revision of the training plan and provided the training for the assigned Lead CRAs and PMs.

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Data Management

Data Management for the Alecardio project was being carried out by teams from the Data Management departments of Julius Clinical (Zeist, The Netherlands), The George Institute for Global Health (Sydney, Australia) and Julius Center for Health Sciences and Primary Care (Utrecht, The Netherlands). This allowed for global coverage for all activities, as well as flexibility.

The Alecardio Data Management team was involved in the following activities:

  • Data management plan development (Outlines the study data flow, as well as applicable sops, work instructions and essential documents.) 
  • Clinical database design and edit check programming (The inform 4.6 Edc system is used to capture and manage the study data. This system allows site staff to enter their study results into an electronic crf (ecrf) via a secured website.) 
  • Design of integrations with external databases (Coding, central lab, pharmacovigilance, ivrs and adjudication databases) (implementation of database integrations circumvented the need to enter the same data in multiple databases, allow for secure and automated data transfer between those databases.) 
  • Data review plan development (A cross-functional data review plan was developed to verify data consistency, patient safety and protocol compliance.) 
  • Training of site and study staff (Julius Clinical developed and facilitated training for site staff and other study staff who are required to work with the ecrf or ecrf data.) 
  • Project management/study team participation (We provided a definition of roles and responsibilities, management of the team, coordination of the activities). 
  • Edc user management (We activated, updated or deactivated accounts based on status in the study, assigned user rights, based on study role and status with regard to ecrf training completion.) 
  • Data consistency review and query management (By means of predefined manual review on the ecrf data and ad hoc review.)
  • Database reconciliations (Ensure that the data matches between all databases that capture those data, regular reconciliations are performed.) 
  • Report, metrics and data listing development and management (Multiple reports, trackers and data, trends.) 
  • Data freezing and locking. Data freezing is the process of making data non-editable, which ensures the clean data retains its cleaned state. At the end of the study, after all data were concluded to be accurate, the ecrf was locked, meaning no further additions, changes or deletions can be made to the ecrf. This assures data integrity for  statistical analysis.
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Site Management & Monitoring

For this study Julius Clinical and its network of local partners managed sites in the European Union, Brazil, Argentina, Mexico, Korea and Thailand. Our GACCT partners manage the sites in the other countries, such as the United States. 80% of the patients recruited for this study were included under the direction Julius Clinical.

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Endpoint Adjudication

Julius Clinical reports occurrence of study endpoints within one working day. This  triggers the adjudication process. All appropriate source documents and CRF information will be assembled and forwarded to the CEC for adjudication. Any possible endpoint forwarded to the CEC will be adjudicated based on pre-specified definitions. Julius Clinical provides the definitions of the endpoints as well as further detail on adjudication procedures.

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Pharmacovigilance

Our Safety Team processes Serious Adverse Events (SAEs) and pregnancies within the timelines as required by the regulatory requirements for safety reporting. They also raise (urgent) safety queries in the electronic Clinical Study Database and follow-up until they have been answered by the Investigator. This team also is responsible for Expedited Safety Reporting, SSR- and DSUR reporting to the participating investigators. For Alecardio, Julius Clinical developed and implemented an Unblinded Distribution process for unblinded expedited safety reporting to Ethics Committees and/or Health Authorities.

Publications

Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial.

Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Rydén L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators.

JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321. PubMed PMID: 24682069

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Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial.

Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial.

Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Rydén L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE.

Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26. PubMed PMID: 24016490

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