Category Archives: Clinician Engagement

Making Sense of it all: A Review of Recent Studies on the Role of Aspirin in Preventing Heart Disease and how ADAPTABLE fits in the Picture

Aspirin is a drug that has been used for decades to prevent the occurrence of a heart attack or stroke by thinning blood so clots do not form. Doctors recommend either high-dose (325 mg) or low-dose (81 mg) aspirin and its use across the United States is fairly balanced between high-dose and low-dose aspirin.

The ADAPTABLE study aims to provide patients and doctors with information on the best dose of aspirin to prevent another heart attack or stroke in people living with heart disease. Doctors refer to this as secondary prevention. Recently, four major studies contributed to our understanding of aspirin’s role in preventing a heart attack or stroke for individuals who do not have known cardiovascular disease and have not experienced a heart attack or stroke. Doctors refer to this as primary prevention. Working with ADAPTABLE patient partner, Greg Merritt, we provide a summary of the results for each of these studies below.

Schuyler Jones, MD

“We all deeply believe in the work required to finish the ADAPTABLE study, and we’re excited to maintain momentum over the fall and winter months. Please take a look of our thoughts on the recent aspirin studies and their applicability to ADAPTABLE.”

The ASCEND Trial: Aspirin in Primary Prevention of Vascular Events in Patients with Diabetes

The ASCEND study included patients with diabetes, a major risk factor for developing heart disease and stroke, but without known heart disease. In this study, approximately half of the 15,480 patients took a low-dose (100 mg daily) of aspirin, and the other half took a placebo pill. A placebo is a substance that does not contain an active drug.

After an average of 7.4 years, patients who took aspirin experienced 11 percent fewer cardiovascular problems, including heart attacks, strokes or mini-strokes, and even death due to a cardiovascular cause. This benefit was stronger in patients weighing 70 kg (154 lbs) or more. Researchers estimated one cardiovascular problem was prevented for every 91 patients who took aspirin. Since aspirin is a blood-thinner, it is also associated with more bleeding problems. For every 112 patients who took aspirin, one more bleeding event occurred compared to patients who did not take aspirin. The increase in bleeding events did not lead to death or a stroke.

The ARRIVE Trial: Aspirin in Primary Prevention in Non-Diabetic Patients at Moderate-Risk of Cardiovascular Diseases

The ARRIVE study was similar to the ASCEND trial (by including patients without known heart disease) but did not include patients with diabetes. This study included patients with a moderate risk for developing heart disease based on factors such as high blood pressure, smoking, or high blood levels of cholesterol. Half of the 12,546 patients took 100 mg of aspirin each day, but this time, aspirin did not prevent cardiovascular problems when compared to a placebo pill. After an average of 5 years, whether or not they took aspirin, approximately 4 percent of all patients experienced either a heart attack, stroke or mini-stroke, unstable chest pain, or death due to a cardiovascular cause. Although bleeding from the stomach or intestines was rare and occurred in less than 1 percent of the patients in both groups, patients who took aspirin were more likely to experience this type of bleeding.

Greg Merritt

“It continues to be an honor and privilege to be a patient partner in the ADAPTABLE Study.As a patient, I often see a wealth of information in the media about the role of aspirin in preventing or treating heart disease. However, my friends, fellow heart patients, and I are often confused by this influx of information. I love having ‘experts that I trust’ put into context these reports. Putting results from these studies in a language lay people can understand helps a great deal, so we don’t spread information that has not been scientifically proven.”

The ASPREE Trial: Aspirin in Primary Prevention of Dementia or Disability

The ASPREE study also included exclusively patients with no previous heart disease or stroke, but only if they were considered healthy and at least 65 to 70 years old. Half of the 19,114 participants took 100 mg of aspirin each day, and the other half took a placebo. After an average of almost 5 years, the study did not show benefits of aspirin in preventing death, dementia, or chronic physical disability, but the risks of major bleeding problems increased. In addition, aspirin did not prevent heart attacks, strokes, and other cardiovascular events. The ASPREE study raises concern for a potentially higher risk of death with aspirin in elderly patients without previous heart disease or stroke. The study found a higher rate of cancer deaths in the participants who took aspirin. This finding should be interpreted with caution because it was not the main focus of the study, and most importantly because previous studies demonstrated the opposite: a protective effect of aspirin on death related to cancer.

Meta-Analysis on the Interaction between Aspirin Dose and Body Weight

The fourth study was a meta-analysis, which combines and evaluates the results from multiple studies. This analysis looked at the results from nine studies involving nearly 103,000 patients (but did not include any of the results from the three studies above). The purpose of the analysis was to decide if aspirin dosing should be different for heavier people compared to people with lower body weights. The authors found that only patients weighing less than 70 kg (154 lbs) benefited from a daily dose of aspirin of 70-100 mg. This benefit (prevention of a heart attack or stroke) decreases as the weight of the patient increases. Patients weighing 70 kg or more benefited from daily doses of aspirin greater than or equal to 300 mg. Patients with lower body weights did not benefit from this higher dose of aspirin in general. Of note, these nine studies did not set out to research an association between body weight and aspirin dose, so results from this analysis should be interpreted with caution.

Although aspirin can prevent cardiovascular events in some patients, these studies show that it comes at a cost in terms of risk of bleeding. Some patients might fear heart attacks and strokes more than bleeding, but some patients might worry more about bleeding. The choice to use aspirin or not must be a joint decision made by a patient and their doctor, using scientific information as well as personal preferences. 

 

 Take-home Messages

  •  In diabetic people without cardiovascular disease, the overall benefits of aspirin is low to moderate.
  • In people at moderate risk of developing a cardiovascular disease, but without diabetes, aspirin doesn’t seem to protect people from a first cardiovascular problem.
  • In people at least 65 to 70 years old without cardiovascular disease, aspirin does not protect against death, dementia, or persistent disability, and neither does it protect from heart attacks or strokes, but it increases the risk of bleeding.
  • The effectiveness of low-dose (70-100 mg) and high-dose aspirin (at least 300 mg) to prevent cardiovascular complications has not been researched in a study specifically designed for this purpose, particularly in patients who have experienced previous heart attacks or strokes. It is expected that benefits of aspirin are higher for this group versus patients who have not experienced these events.
  • A relationship between weight and aspirin dose may exist, but a future study designed specifically to research this association is needed.
  • ADAPTABLE is the largest study comparing two doses of aspirin in patients who have cardiovascular disease. This is a different population than the recent studies, which was comprised of study participants with no known heart disease.
  • The benefit of aspirin to prevent future events in people who have heart disease is established, but the optimal dose is not known. Results from ADAPTABLE will provide information to help doctors and patients answer this question.

Importance of Diversity in Clinical Research

The main phases of a clinical research study include: 1) identification and recruitment of study participants, 2) data collection and monitoring, 3) analysis of study results, and 4) distribution of study findings. ADAPTABLE team members are currently focused on the first two phases. In this article, we explore why it is important that people of different ages, races, ethnic groups, and genders are included in clinical trials.

How Does Who you are Impact Your Risk for Disease?

Sex, age, race, and ethnicity all play an important role in how different diseases, medicines, and treatments affect people. For example, the American Heart Association (AHA) states that the prevalence of high blood pressure in African-Americans is the highest in the world. African-Americans are disproportionately affected by obesity and more likely to have diabetes than non-Hispanic whites. The Centers for Disease Control and Prevention (CDC) estimates that for American Indians/Alaska Natives and Asian Americans/Pacific Islanders, heart disease is second only to cancer. Heart disease affects women as much as men, but symptoms and the warning signs for women aren’t the same as in men.

Despite what is known about how certain groups of people may respond differently to disease; traditionally, the majority of cardiovascular clinical research study participants are white men. Increasing diversity in clinical research studies is a priority for the Food and Drug Administration and the ADAPTABLE team in making sure results provide evidence that is relevant and helpful to a wide range of people. Diversity in clinical research studies helps ensure that the results will have an impact on the people the study is intended to help.

How Can Researchers Work to Improve Diversity in Clinical Research?

So how do researchers work to ensure representation from a range of participants in clinical research studies? The short answer is education, trust, partnership, and access.

Providing Education: Too often people who choose not to participate in trials say that they lack information. Providing educational resources about clinical research—what it is, why it is important, and how to participate—is a good first step to filling this information gap and increasing participation of underrepresented groups. To be effective these resources must be written in plain language, culturally appropriate, and available in local languages.

Establishing and Building Trust in Communities: Lack of trust in clinical research by minority groups continues as a reason individuals decline participation in trials. PCORnet, the National Patient-Centered Clinical Research Network, is leading a shift in its approach to clinical research from the traditional sense of work that is done to the community to work that is done with the community. PCORnet has hosted events focused on fostering trust in clinical research and provides patients, caregivers, and others opportunities to partner with researchers to improve the clinical research process.

Involving patients as partners: By sharing their experiences on what it’s like to live with a disease, thoughts on treatments, and what research topics are most important, patients can make a significant impact on all aspects of clinical research, from the design of the study to the dissemination or sharing of the results.  In ADAPTABLE, a diverse group of patient partners called the Adaptors are integral team members who are passionate about representing and reflecting the best interests, concerns, and welfare of potential, current, and future clinical research participants.

ADAPTABLE team members frequently participate in community health fair events to provide information about clinical research, the ADAPTABLE study, and heart-health awareness. These events provide opportunities to engage with people, to make personal connections, and build trust with community members.

Jacqueline at a local health event talking about ADAPTABLE and heart health.

As a woman of color and a heart disease patient, Adaptor Jacqueline Alikhaani, is passionate about using her personal health experiences to not only heighten awareness of patient-centered research, but to enhance diversity in clinical trials. “One of the biggest advantages we have with ADAPTABLE is the diversity of the Adaptors team. We have women, men, and people from different races, ethnic, and socioeconomic backgrounds. We are bringing a wealth of experiences to help shape the design and direction of the study,” says Jacqueline. You can learn more about Jacqueline and how she serves as an architect of change in spreading the word about the role of patients in research and increasing minority participation in clinical research.

 Providing access to research: When designing a clinical trial, researchers plan to have study sites spread across the country and located in racially diverse communities to increase participation from everyone. ADAPTABLE enrolls participants from large health systems that are part of PCORnet’s Clinical Data Research Networks.

Want to learn more?

 If you are looking for general information about clinical research or resources about diversity in clinical research, check out the following resources:

Center for Information & Study on Clinical Research Participation

Minorities in Clinical Trials Fact Sheet

Engagement in Research

 

2017: Year in Review

The ADAPTABLE Study team reflects on the many accomplishments and milestones throughout 2017 — a year of record enrollment, new network collaborations, and actively engaging with and sharing the voice of study participants. We wish you the best in 2018 and look forward to continuing to build a community where participants, researchers, and clinicians partner together to improve cardiovascular health.

ADAPTABLE Study Welcomes HealthCore and LHSNet Networks to the Team

The National Patient-Centered Clinical Research Network (PCORnet) demonstration study, ADAPTABLE, welcomes two new partners as participating networks: HealthCore-Anthem Research Network and Patient-Centered Network of Learning Health Systems (LHSNet).

HealthCore, a subsidiary of Anthem, is a health plan research network with 140 highly specialized, multi-disciplinary professionals dedicated to health services and outcomes research. Through Anthem, HealthCore has access to approximately 60 million individuals from across the United States. HealthCore began its initial outreach to 135,000 eligible patients covered by Anthem, and in less than a month more than 400 eligible patients have visited the ADAPTABLE patient portal and 104 of them have already enrolled. The addition of HealthCore as an enrolling site for ADAPTABLE creates a novel partnership where health plan claims data are contributing to the primary data collected in this clinical study.

LHSNet is a diverse network of health institutions across the mid-west and mountain states that collectively serve approximately 10 million patients including underserved and rural areas. Similar to HealthCore and other participating networks in ADAPTABLE, the six LHSNet sites will use a computable phenotype, an electronic formula within the health record system, to identify eligible patients at each of the participating locations.

Highlighting the collaborative nature of PCORnet, LHSNet leadership is actively incorporating best practices from currently enrolling sites to optimize clinician engagement, patient engagement, and recruitment strategies. “The collaborative environment between the site teams to work together and learn how to successfully manage a large pragmatic clinical study is something I have never witnessed on any other large clinical trial,” said Project Leader Holly Robertson, PhD. “It is definitely a unique experience and it is really exciting to be a part of such a novel study.”

The addition of these networks allows for the expansion of ADAPTABLE to new geographical areas and will help to support the goal of enrolling up to 15,000 patients to answer a simple but critical question that is important to individuals living with heart disease and their providers: What is the most effective dose (81mg or 325mg) of aspirin for patients with cardiovascular disease? “The ADAPTABLE demonstration study within PCORnet continues to break new ground with innovative ways to engage patients and clinicians in important, pragmatic clinical research, as demonstrated by the inclusion of HealthCore and LHSNet,” says ADAPTABLE Co-Principal Investigator Schuyler Jones, MD.

Facebook Live Broadcast: What is the Optimal Dose of Aspirin for Patients with Heart Disease?

In conjunction with The American Heart Association  2016 Scientific Sessions and REACHnet CDRN Health in Our Hands Network,  ADAPTABLE will be live on Facebook on November 15 at 10:15 CST. Co-Principal Investigator, Dr. Matthew Roe, and patient participant, Ken Grigoire, will answer your questions about ADAPTABLE, a study that seeks to understand what is the optimal dose of aspirin for patients with heart disease.

facebook-live-broadcast

The ADAPTABLE study is being presented to fellow clinicians, researchers and scientists attending Scientific Sessions, Nov. 12th – Nov 16th in New Orleans. #AHA16 is the leading cardiovascular meeting in the country with more than 17,000 professionals attending annually. The scientific programming is designed to improve patient care by providing a forum for researchers and scientists to share significant advances in prevention, diagnosis and treatment of cardiovascular disease from different perspectives. www.scientificsessions.org.

Join us on November 15 at 10:15 CST for the LIVE Q&A by visiting: www.facebook.com/events/363697957306812/

 

ADAPTABLE Study Kick-Off Meeting: Determining the Path Forward for ADAPTABLE and Pragmatic Research

Patient engagement and patient-centricity are hot topics in clinical research and study teams are trying creative approaches to involve patients in the research process. These teams can look to the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial as an emerging model for patient engagement in randomized trials. Patient leaders, study investigators, and operations and research staff gathered together on October 28, 2016 in Washington D.C. to discuss ideas and strategies for making this novel, pragmatic study a success.
adapt-study

Continue reading ADAPTABLE Study Kick-Off Meeting: Determining the Path Forward for ADAPTABLE and Pragmatic Research

The Role and Importance of the Clinician in ADAPTABLE

In this feature of Ask ADAPTABLE, Dr. Schuyler Jones, an investigator with the Duke Clinical Research Institute Coordinating Center, discusses the role and importance of the clinician in the ADAPTABLE study.

Q: What is the role of the clinician in ADAPTABLE?

SJ: The role of the clinician in ADAPTABLE is that of support. Patients, especially older patients, like to hear about and discuss participation in clinical trials with their clinicians. We hope that clinicians will be able to answer questions, confirm eligibility, and validate that participating in ADAPTABLE may be of benefit to their patients. We expect that clinicians will be aware of ADAPTABLE and discuss the benefits and attributes of the study:

  • Low-risk study for the participant
  • Answers an important clinical question
  • Defines an effective model for the conduct of clinical research

Watch this video to learn more about the role of clinicians in ADAPTABLE and how clinicians can be ADAPTABLE champions.

Q: What types of challenges do clinicians face in clinical research and how can studies like ADAPTABLE help? Continue reading The Role and Importance of the Clinician in ADAPTABLE

ADAPTABLE: Answering an Important Clinical Question while Testing a New Approach to Conducting Pragmatic Clinical Trials

In April, Ty Rorick and Lisa G Berdan of the ADAPTABLE Coordinating Center at Duke Clinical Research Institute (DCRI) visited the Research Action for Health Network (REACHnet) team. “REACHnet has developed a very clever way of using tablets in some of their clinics to help reach potential participants previously identified using the computable phenotype. They have just enrolled their first ADAPTABLE patient and we’re very excited to see how tablet technology can help engage participants early in the screening process” said Lisa G Berdan, Director, DCRI Global Cardiovascular Outcomes Trials.

In this feature of Ask ADAPTABLE, Beth Nauman, Research Director at REACHnet, shares the network’s role in the National Patient-Centered Clinical Research Network (PCORnet) and ADAPTABLE.

Continue reading ADAPTABLE: Answering an Important Clinical Question while Testing a New Approach to Conducting Pragmatic Clinical Trials

ADAPTABLE Presented to the American College of Cardiology Board of Governors

ADAPTABLE physician leaders Robert Harrington and Matthew Roe along with operations team leaders Lisa Berdan and Tyrus Rorick presented ADAPTABLE to the American College of Cardiology (ACC) Board of Governors (BOG) on April 1, 2016 during the annual ACC scientific sessions. The ACC BOG is the grassroots liaison organization that represents the local state ACC chapters within the ACC headquarters. Their presentation generated a thoughtful discussion about the goals and objectives of ADAPTABLE.  The BOG members expressed uniform support in communicating the importance of ADAPTABLE to local chapter leaders and local ACC state members and constituents to raise awareness of the trial among cardiologists across the United States. The ADAPTABLE team committed to providing the BOG with study updates, to connect local chapter leaders with the leaders of ADAPTABLE at the participating CDRNs and health care systems, and to work together with the BOG to facilitate the widespread dissemination of information about ADAPTABLE to the cardiology community.  

 

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