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Published on November 14, 2017

Clinical Trials Give Patients Access to Latest Cardiovascular Treatments

Cardiologists at North Kansas City Hospital are leading several clinical trials that give patients access to cutting-edge protocols that could lead to advances in the prevention, diagnosis and treatment of cardiovascular diseases.

“We strive to be at the forefront of cardiac care by providing access to investigational treatment options that otherwise would not be available to patients, who appreciate having high-caliber, research-focused care close to home,” said Zafir A. Hawa, MD, FACC, FSCAI, a cardiologist with Meritas Health Cardiology and medical director of cardic clinical research at NKCH.

ODYSSEY Outcomes

Dr. Hawa pointed to ODYSSEY Outcomes, which at mid-trial led the U.S. Food and Drug Administration to approve the use of the cholesterol-lowering PCSK9 antibody alirocumab. The trial compared the effect of alirocumab with placebo in patients who recently experienced a heart attack or unstable angina. These patients were unable to control their LDL cholesterol despite taking maximally tolerated doses of lipid-lowering medications. Subjects randomly received biweekly injections of alirocumab every two weeks or a placebo. People taking alirocumab had their doses increased at week eight if their LDL cholesterol remained > 50 mg/dL. This five-year trial with more than 18,000 patients from 57 countries closes in December.

“During the trial period, the PCSK9 inhibitor had not yet been approved by the FDA, but some of our trial patients potentially had access to it because of our research,” Dr. Hawa said. His colleague, Michael W. Farrar, MD, FACC, FASE, is the hospital’s principal investigator for ODYSSEY Outcomes.

TWILIGHT

Dr. Hawa is the PI for the four-year TWILIGHT trial, which evaluates the effect of Brilinta® (ticagrelor) alone versus Brilinta plus aspirin in patients with a coronary stent. After taking aspirin and Brilinta for three months, patients remain on Brilinta but are randomized to either aspirin or placebo for an additional 12 months. Because these high-risk patients have had a percutaneous intervention with at least one drug-eluting stent, researchers want to determine if reducing the time of dual antiplatelet therapy will reduce bleeding events while preventing ischemic adverse events.

“Brilinta is expensive at about $380 a month, but our trial participants receive it free,” Dr. Hawa said. “Even with insurance, a patient could pay $150 a month. One of my patients was allergic to her current treatment, which was Plavix®. Putting the patient in this trial saved the patient a huge amount of money.”

Cardiovascular Clinical Trials

Meritas Health Cardiology physicians have conducted cardiovascular clinical trials at North Kansas City Hospital since 2008. Today, Scott S. Chapman, MD, FACC; Michael W. Farrar, MD, FACC, FASE; David M. Hahn, MD, FACC; and Zafir A. Hawa, MD, FACC, FSCAI are principal investigators. In addition to the ODYESSY and TWILIGHT trials, they have patients participating in the following randomized, placebo-controlled multi-center trials:

  • CONNECT HF: A three-year, 8,000-patient trial that looks at quality improvement initiatives for heart failure patients with acute HF and reduced ejection fraction one year after hospitalization; interventions include interactive and informational mobile apps
  • HEART-FID: A three-year, 3,000-patient trial that assesses the effects of IV Injectafer® (ferric carboxymaltose) compared with placebo as treatment for heart failure with iron deficiency on three outcomes measures: the 12-month mortality rate, hospitalization for worsening heart failure and the six-month change in a six-minute walk test
  • PARADISE-MI: A three-year trial that includes more than 4,600 patients; it compares twice daily Entresto® with ramipril in reducing heart failure after myocardial infarction
  • THEMIS: A five-year trial that consists of nearly 20,000 patients; it evaluates the effect of taking Brilinta (ticagrelor) twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with Type 2 diabetes
  • UPSTREAM: A three-year observational study of 2,000 participants that seeks to address the data gap between arrival of NSTEMI patients in the Emergency Department and diagnostic angiography by following the use of antiplatelet agents in the ED within the first 72 hours after arrival and at least four hours before diagnostic angiography.

NKCH Support

Dr. Hawa and his colleagues are grateful for NKCH’s support. The hospital designated two cardiovascular study coordinators, Dianne Kruger-Sargent, BSN, RN, and Julie Dehner, BSN, RN, who screen, enroll, follow and manage trial participants. “Dianne and Julie are vital to our success,” Dr. Hawa said. “They help us establish connections with the research community, including Duke Clinical Research Institute and Harvard Clinical Research Institute. Because of their due diligence and our performance, these and other organizations continue to look to North Kansas City Hospital to participate in their clinical trials.”


Zafir A. Hawa, MD, FACC, FSCAIZafir A. Hawa, MD,FACC, FSCAI

Dr. Hawa earned his medical degree from the University of Bombay. He completed his internal medicine residency at the University of North Dakota Medical Center, critical care fellowship at the University of Pittsburgh Medical Center, and cardiology research, cardiology and interventional cardiology fellowships at Western Pennsylvania Hospital.