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Published on November 01, 2018

Clinical Trial Examines Innovative Myocardial Infarction Treatment

North Kansas City Hospital is currently the only hospital in Missouri and Kansas enrolling patients in a four-year, international clinical trial to determine if an innovative treatment can safely reduce the risk of early recurrent myocardial infarction.

NKCH will be among 1,000 medical centers involved in the study, which will have more than 17,000 participants. To date, 42 U.S. centers and nine others in Australia, Canada and New Zealand have begun enrolling participants.

AEGIS-II

AEGIS-II Eligibility

Inclusion Criteria

  • Male or female least 18 years of age
  • Evidence of myocardial necrosis, consistent with Type I (spontaneous) MI
  • No suspicion of acute kidney injury
  • Evidence of multivessel coronary artery disease and at least one of the following established risk factors:
    • Age ≥ 65 years
    • Prior history of MI
    • On pharmacological treatment for diabetes mellitus
    • Peripheral artery disease

Exclusion Criteria

  • Ongoing hemodynamic instability
  • Evidence of hepatobiliary disease
  • Evidence of severe chronic kidney disease
  • Plan to undergo scheduled coronary artery bypass graft surgery
  • Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin

The trial, AEGIS-II or ApoA-I Event Reducing in Ischemic Syndromes II, studies the efficacy and safety of CSL112 in reducing the risk of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome. CSL112 is a formulation of apolipoprotein A-1 purified from human plasma. Study candidates must have been diagnosed with either ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction, including those people with percutaneous coronary interventions or who are medically managed.

This is a Phase 3, double-blind, randomized, placebo-controlled, parallel-group study. Patients receive four weekly infusions of CSL112 (170 CCs each) or placebo (25% albumin solution diluted to 4.4%), with the first infusion completed at MI hospitalization. (See AEGIS-II Eligibility at right.)

“This is an exciting trial,” said Zafir A. Hawa, MD, FACC, FSCAI, a cardiologist with Meritas Health Cardiology and medical director of cardiac clinic research at NKCH. “It gives our patients access to a treatment they would not otherwise have available.”

AEGIS-I

Prior to AEGIS-II, results from the Phase 2B AEGIS-I, conducted from August 2014-December 2015 with 1,267 participants, showed CSL112 enhanced cholesterol efflux capacity. Efflux is a process that removes excess cholesterol from plaque and transports it to the liver.

“The CSL112 acts as a scavenger, taking the LDL from the plaque down to the liver, where it is eventually destroyed,” Dr. Hawa said. “A small 2008 study showed that five to seven days after a single infusion, femoral plaque lipids were reduced by more than 50%.”

The Challenge

According to the World Health Organization, survivors of myocardial infarction have an increased risk of recurrent infarctions and annual death rate of 5%, six times that in people of the same age who do not have coronary heart disease. This is despite optimal care with:

  • Percutaneous Coronary Interventions
  • Medications
    • Aspirin
    • ACE Inhibitors or angiotensin II receptor blockers
    • Antiplatelet agents
    • β blockers
    • Cholesterol-lowering medications
  • Cardiac rehabilitation
  • Lifestyle changes related to diet, exercise and smoking

This is despite optimal care. “After an MI, patients are placed on four or five medications but are still having recurrent events,” Dr. Hawa said. “What we’re doing is not enough. There is something we are missing. We’re not substituting CSL112 for the current standard of care, but this treatment may be the key to preventing recurrent events.

Additional Cardiovascular Clinical Trials

Meritas Health Cardiology physicians have conducted cardiovascular clinical trials at North Kansas City Hospital since 2008. In addition to the AEGIS-II, NKCH continues to enroll patients in two other randomized, placebo-controlled multi-center trials:

  • 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 that compares twice daily Entresto® with ramipril in reducing heart failure after myocardial infarction

Zafir A. Hawa, MD, FACC, FSCAI

Zafir Hawa, MDDr. 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.