Anchorage Fire Department, Alaska Cardiovascular Research Foundation join Providence Alaska Medical Center to evaluate effectiveness of Zalunfiban
ANCHORAGE, Alaska — The Anchorage Fire Department, Providence Alaska Medical Center and Alaska Cardiovascular Research Foundation (the research arm of the Alaska Heart & Vascular Institute) will collaborate on a study of a new medication for treating patients experiencing a heart attack. The study begins in March.
The Phase 3 multi-center, double-blind, randomized, placebo-controlled study is designed to evaluate the effectiveness of zalunfiban, an investigational drug, versus a placebo (an inactive substance) in patients experiencing a ST-segment elevation myocardial infarction, or a STEMI. The drug acts on the clotting mechanism that occurs in this type of heart attack and has been shown in earlier studies to help stabilize the condition and in some cases to improve blood flow prior to the use of conventional artery-opening therapies.
Specifically, the study will assess the medical outcomes of patients 30 days after receiving either the investigational drug or placebo. An investigational drug is a product that has not yet received approval by the Food and Drug Administration (FDA). Financial support to conduct the research activities will be provided by the sponsor, CeleCor Therapeutics, which will oversee/pay for the clinical trial and collect and analyze the data.
The study, entitled “A Phase 3 prospective, blinded, randomized, placebo controlled international multi-center study to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in subjects with ST-elevation myocardial infarction in the pre-hospital setting” — or “CeleBrate” — is being done in multiple countries in Europe and North America, including The Netherlands, Czech Republic, Hungary, France, the United States and Canada.
The study will include males aged 18 or older or females aged 50 or older who are having a heart attack. Women who participate must be post-menopausal or not able to become pregnant because they have had a hysterectomy, or their tubes tied.
All patients will continue to receive the current standard of care (treatment) for a heart attack. Zalunfiban or a placebo will be added to the standard of care in the field and will be administered by the Alaska Fire Department Emergency Services personnel (EMS).
Because a heart attack is a life-threatening emergency that requires immediate treatment, and patients are not able to make informed decisions while suffering from a heart attack, patients will be enrolled in the study without providing the more involved formal informed consent typical of scientific drug trials. EMS or paramedics treating patients with a heart attack will provide individuals with a short description of the study. However, if a patient or their family member objects to participating in the study, the patient will not be enrolled and will continue to receive typical/standard of care treatment for heart attack. This is an FDA-approved research method know as Exception from Informed Consent (EFIC) which has included early notifications to the community to allow those who already know that they do not want to participate to receive a wrist band that signifies that decision. The study will likely run for about a year.
“The Anchorage Fire Department is looking forward to participating in the upcoming CeleBrate trial,” said Michael Levy, M.D., medical director of the Anchorage Fire Department. “Anchorage has a very effective system of care for our citizens experiencing heart attacks that begins with EMS dispatch and EMS response with EMTs and paramedics who begin treatment and stabilization. EMS initiates special alerts to the local receiving hospitals where such patients are rapidly evaluated and treated by the heart teams. This system of care saves lives and decreases heart damage.
“The CeleBrate Trial adds the study medication to our standard therapy in consenting patients but does not alter our standard, effective treatment. Trials such as this are the foundations for improvement in medical care,” he added.
A heart attack is a life-threatening condition in which a blood clot blocks an artery supplying blood to the heart. Research has shown that treating patients soon after the onset of symptoms provides the best opportunity to reduce the risk of long-term effects from a heart attack. These long-term effects include heart failure and death.
Since emergency research without formal consent is in a special category of research, community outreach efforts are being made to provide information, answer questions, and get community members’ input about this important clinical research. Before the study starts, researchers will be reaching out to community members to gain as much input as possible.
For more information about the CeleBrate study, visit the study website or contact:
- CeleBrate Study celebrate@celecor.com
- Providence Alaska Medical Center Research Support Service
akpamc.oncologyresearchsupport@providence.org - Anchorage Fire Department WWAFD@ci.anchorage.ak.us
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About Providence Alaska Medical Center
Providence Alaska Medical Center, a nationally recognized trauma center and Alaska’s only Magnet hospital, is part of Providence, a not-for-profit network of hospitals, care centers, health plans, physicians, clinics, home health services, affiliated services and educational facilities. For more information, visit providence.org/locations/ak/alaska-medical-center.
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