ARRIVE

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About the Study

Rationale

ARRIVE (Aspirin to Reduce Risk of Initial Vascular Events) is one of the largest clinical studies ever conducted in a population at moderate risk of initial events associated with cardiovascular and cerebrovascular disease (CVD).

  • Approximately 12,000 patients in seven countries: Germany, Italy, Spain, the United Kingdom, Poland, Ireland, and the United States, with over 400 study sites participating.
  • Aims to further demonstrate the efficacy and safety of low-dose (100-mg daily) Aspirin in preventing first events associated with CVD in moderate risk individuals. Moderate risk of Coronary Heart Disease (CHD) is defined as approximately 10-20%, 10-year risk of an event, which corresponds to a mean 10-year CVD risk of approximately 30%.
  • Designed to demonstrate the efficacy of Aspirin in preventing initial events associated with CVD in a population with no known history of CVD, but who are at moderate risk.
  • And to create increased awareness among patients and healthcare professionals about the appropriate use of Aspirin for prevention of initial events associated with CVD.

ARRIVE is being undertaken to expand the already existing, strong body of evidence supporting use of Aspirin for primary prevention of events associated with CVD. Aspirin is approved for primary prevention of events associated with CVD in over 35 countries and is recommended for this use in guidelines issued by the American Heart Association and the European Society of Cardiology, among other major health organizations. While a large body of evidence supports use of Aspirin to prevent first events associated with CVD, including six large, randomized, controlled clinical trials involving nearly 100,000 patients, and a meta-analysis of these six studies, the overall CV-baseline risk level was low in five of the six studies.

Because ARRIVE is one of the largest trials ever to study the effects of Aspirin in preventing primary events associated with CVD in a population at moderate risk, a critical success factor for the trial is the recruitment of patients across multiple countries considered to be at moderate risk.

An innovative method that models overall risk for the composite primary endpoint (risk of coronary heart disease, plus risk of stroke, plus risk of cardiovascular death) was used to establish the entry criteria for ARRIVE.

This ARRIVE risk calculation methodology combines elements of four existing risk calculator methods including Framingham and PROCAM for CHD, Framingham Stroke for stroke risk, and SCORE for cardiovascular death.
-- It estimates risk accounting for differences that exist between low- and high-risk countries.
-- It ensures that the recruited study population will meet the definition of moderate risk: a mean 10-year CVD risk of approximately 30%.

Study Design and Primary Endpoint

  • Randomized, multicenter, double-blind, placebo-controlled, parallel group study.
  • Will continue until an adequate number of events associated with CVD are observed for analysis. It is estimated that this will take approximately five years of follow up.

Primary endpoint of ARRIVE will be an evaluation of the time to first occurrence of non-fatal myocardial infarction (MI), non-fatal stroke, and CVD death (including both fatal MI and fatal stroke) as a composite endpoint. The use of a composite endpoint comprising cardio- or cerebrovascular death combined with other non-fatal outcomes has become a standard assessment technique in cardiovascular research studies and was recently utilized in the meta-analysis of the six key studies evaluating Aspirin in primary prevention.

Eligibility Criteria

There are many patients, such as those in the ARRIVE trial, who do not have a history of events associated with CVD or symptomatic disease, but instead have CVD risk profiles sufficiently high enough that they may benefit from treatment with Aspirin. These moderate risk patients may be appropriate candidates for consideration of Aspirin therapy.

Key inclusion criteria

  • Men aged 55 years or older with two to four CVD risk factors
  • Women aged 60 or older with three or more CVD risk factors
  • CVD risk factors include elevated total and/or LDL cholesterol, low HDL cholesterol, cigarette smoking, elevated blood pressure, current use of medication to treat high blood pressure, and a family history of early CHD.

Key exclusion criteria

  • Previous history of MI, stroke, or other significant cardiovasular or cerebrovascular condition are not eligible to participate
  • Currently on antiplatelet or anticoagulant therapy
  • Treated Type I or II diabetes
  • Additional risk factors that place patients at greater than moderate CVD risk
  • Other significant conditions that might affect the patient's ability to complete the study will be excluded
  • Recent (in the past year) history of gastrointestinal or genitourinary bleeding, or other bleeding disorders

ARRIVE Executive Committee Members

The ARRIVE trial is overseen by an Executive Committee of renowned medical and statistical professionals from around the world. The committee members are:

J. Michael Gaziano, MD, MPH

Dr. Gaziano heads the ARRIVE Trial Executive Committee. He is Chief, Division of Aging at Brigham and Women's Hospital in Boston, Mass., USA, and Director, Massachusetts Veterans Epidemiology, Research and Information Center and the Geriatric Research, Education and Clinical Center at VA Boston Healthcare System. He also is Associate Professor at Harvard Medical School.

Carlos Brotons, MD, MPH, PhD

Dr. Brotons is a General Practitioner and the Director of Research at Sardenya Primary Health Care Center in Barcelona, Spain. He also is the Chairman of the European Network for Prevention and Health Promotion in Family Medicine/General Practice.

Claudio Cricelli, MD

Dr. Cricelli is President of the Italian Society of General Practitioners and is a physician at Sculoa Europea di Medicina Generale in Florence, Italy. He has been involved in numerous clinical trials in a variety of medical disciplines.

Harald Darius, MD

Professor Darius is Chairman of ALKK, a working group of leading cardiology hospital physicians. He is a Director of the Clinic of Internal Medicine -- Cardiology and Conservative Intensive Medicine at Vivantes Klinikum Neukolln, in Berlin, Germany.

Philip Gorelick, MD, MPH, FACP

Dr. Gorelick is Head and Chief, Neurology Service, at the University of Illinois at Chicago, USA. He also is the John S. Garvin Professor at the University of Illinois at Chicago.

George Howard, DrPH

Dr. Howard is Chairman, Department of Bio Statistics, University of Alabama School of Public Health, in Birmingham, Ala., USA. He has extensive experience in biostatistics, data management, and the direction of coordinating centers in multicenter studies.

Thomas A. Pearson, MD, MPH, PhD

Professor Pearson is Department Chairman, Community & Preventive Medicine, at the University of Rochester Medical Center in Rochester, N.Y., USA. He also is the Albert D. Kaiser Professor of the Division of Epidemiology at the university medical center.

Peter M. Rothwell, MD, PhD, FRCP

Professor Rothwell is Director of the Stroke Prevention Research Unit in Oxford, England, which he founded. He also is Professor of Clinical Neurology at Radcliffe Infirmary.

Luis M. Ruilope, MD

Professor Ruilope is Head of the Hypertension Unit at 12 de Octubre Hospital in Madrid, Spain, and Associate Professor of Internal Medicine at Complutense University. He also currently serves as the President of Spanish Hypertension Society. Madrid, Spain.

Michal Tendera, MD

Professor Tendera is Professor of Medicine and Head of the Department of Cardiology in Katowice. Michal Tendera served as President of the Polish Society of Cardiology in 1995-98, and as President of the European Society of Cardiology between 2004 and 2006. He is on the Editorial Board of the European Heart Journal, Polish Heart Journal, and several other cardiology journals.

Gianni Tognoni, MD

Dr. Tognoni is Head of the Department of Pharmacology at Institute Mario Negri in Milan, Italy. He also serves as a permanent consultant of the World Health Organization. He is a recognized expert worldwide in the field of pharmacoepidemiology.

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