Launch of the Largest International Registry in
Coronary Artery Disease Patients – CLARIFY

– Registry Set to Improve Disease Understanding, Management and Help Save Lives –

Barcelona, Spain – Monday 31st August 2009 – CLARIFY, the largest international registry to ever be carried out in stable coronary artery disease (CAD) outpatients was launched today in around 40 countries worldwide, at the European Society of Cardiology (ESC) Congress.

The CLARIFY registry (ProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease) is designed to increase knowledge and understanding of CAD.  Most of the data available on CAD stem from randomised clinical trials, which have limited generalisability due to the stringent selection process of participants, or include patients hospitalised for acute events or procedures or focus on patients with anginal symptoms. There is only limited data regarding stable outpatients with CAD, their contemporary management and outcomes. The new registry is designed to provide important epidemiological and clinical data, including an assessment of the role of heart rate in the prognosis of CAD patients, and will hopefully help improve disease management by identifying gaps between evidence and actual practice.

CAD remains the leading cause of death worldwide. Improved understanding of the management and outcomes of these patients is paramount to reducing the disease burden. Reducing the elevated heart rate is a new approach that could potentially help decrease morbidity and mortality in these patients. “Despite the growing importance of heart rate in the treatment of CAD, there is little existing data on resting heart rate in patients seen in day-to-day clinical practice, so a registry in CAD patients involving heart rate is long overdue, particularly as heart rate needs to be carefully measured,” comments study lead Professor Philippe Gabriel Steg, Bichat-Claude Bernard Hospital, Paris, France. “Results from CLARIFY will provide important new clinical evidence to help improve the treatment of CAD and eventually save patients’ lives,” adds Professor Tendera, Medical University of Silesia, Katowice, Poland.

CLARIFY will involve a minimum of 30,000 outpatients with stable CAD from around 40 countries worldwide, who will be followed for five years. These subjects will be representative of CAD patients seen by cardiologists and primary care physicians in daily clinical practice. The first patients will be enrolled in October 2009.

The registry will gather important information about the characteristics, management, outcomes and prognosis of CAD patients, with data collected prospectively at annual visits (12, 24, 36, 48 and 60 months). Patients will be evaluated not only on heart rate but also on their medical history, risk factors, and current chronic medical treatments to name a few criteria. The overall aim of CLARIFY is to identify:

  • The current profile of the CAD patient population, including demographics and clinical features
  • The current daily treatment practices in CAD and variations according to treatment setting and geography
  • The clinical outcomes and changing patterns in stable CAD management during the 5-year follow-up period

CLARIFY also will determine long-term prognosis in this contemporary-treated stable patient population with a view for developing a powerful and comprehensive risk prediction model, including all potential prognostic factors, including resting heart rate.

“It is anticipated that CLARIFY will offer important new evidence for heart rate reduction as a new management approach to cardiovascular disease,” comments Professor Jean Claude Tardif from the Montreal Heart Institute, Quebec, Canada. “Overall, CLARIFY will help to improve the care of patients with CAD by providing physicians with a greater understanding of patient management and outcomes.”

The CLARIFY registry is funded by an educational grant from Servier, France’s leading independent pharmaceutical company. Data will be collected and analysed at the Robertson Centre for Biostatistics, Glasgow, UK, under the guidance of Prof Ian Ford, and the study is led by an academic executive steering committee, chaired by Prof P.G. Steg, INSERM U-698, Hôpital Bichat-Claude Bernard and Université Paris 7, Paris, France.

– ENDS –

Notes to editors

Coronary artery disease (CAD)
Coronary artery disease, also known as ischemic heart disease, is the most common type of heart disease. CAD is the leading cause of death worldwide and is predicted to remain so for the next 20 years.1 Approximately 3.8 million men and 3.4 million women die from CAD each year,2 and in 2020, it is estimated that this disease will be responsible for a total of 11.1 million deaths globally.1

CAD could remain undetected for years and manifest suddenly as an acute heart attack.  Although CAD might be a silent disease, in the majority of patients it is symptomatic. It causes angina – chest pain evoked by exercise and other factors, and may lead to heart failure, placing a huge impact on quality of life. Despite lifestyle modifications and advances in the medical management, CAD remains a global health problem and there is a need for new and effective preventative treatments.

Cardiovascular disease patient registries

Access to data compiled on modes of therapy, types of intervention and treatment regimens and outcomes across as large a patient population as possible, is a valuable asset in working towards a gold standard of treatment for cardiovascular disease management, and patient registries (prospective health surveys) are one of the key sources of this data.

For further information, please contact:
Monica Gounaropoulos, Tonic Life Communications (Tel. +44 20 7798 9910) monica.g@toniclc.com
Claire Mosley, Tonic Life Communications (Tel, +44 20 7798 9926) claire.mosley@toniclc.com

References
1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3:e442.
2. WHO. The global burden of disease: 2004 update. Available at: www.who.int/healthinfo/global_burden_disease/2004_report_update/en/index.html.