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Clinical Trials
New approaches in the diagnosis, prevention, and treatment of heart disease occur as a result of clinical trials. The specialized research staff of The Cardiovascular Group and Centra Stroobants Heart Center is dedicated to performing clinical trials safely and efficiently, while simultaneously addressing the individual needs of each research study patient. Special care is taken to help patients understand the study so that they can be active participants in their treatment. All patient information regarding clinical trials is kept confidential.
Individuals participating in a clinical trial must meet certain requirements, such as physical condition, age, or stage of disease and must be willing to sign a consent form. Consent must be given freely without influence to participate in a study after being informed of the purpose, procedures, risks, and benefits.
Our commitment is to be on the cutting-edge of cardiovascular care through the introduction of promising new methods of treatments and participation in clinical research. Our research projects are at least nationwide and most are worldwide efforts.
Rocket AF, Coral, Champion PCI, Early ACS and Improve It clincal trials are no longer being recruited for, but follow-up for participants is on-going. Please see below for clinical trials currently being offered at our facility.
- OSPREY
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To qualify for this study, you must have symptomatic PAD. (Peripheral Artery Disease) PAD is a narrowing of the arteries in the legs or arms. The most common symptoms are cramping and pain or tiredness in the leg or hip muscles while walking or climbing stairs. Typically, the pain goes awy with rest, but flares up again when walking resumes. Most cases of PAD can be managed with lifestyle changes and medical therapy; however, left undiagnosed it could lead to serious conditions.
An individual with PAD can be included in this study if the physician determines that the stenosis (blockage) can be successfully treated with the Misago stent. Qualifying patients receive an investigational stent at no charge, then thorough and attentive follow-up for 2 years. Like all clinical trials, this trial has specific guidelines about who can particpate. If you, or someone you know may benefit from this trial, please talk with your physician or cardiologist.
- APPRAISE 2
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To qualify for this study, you must have been recently hospitalized for an ACS event or stent procedure.
This study is appropriate for patients within 7 days of a heart attack or unstable angina. The subject must have at least 2 high-risk criteria, such as diabetes or prior heart attack. Patients are randomized to apixaban or placebo. Apixaban inhibits one of the clotting factors in the blood. 10,800 patients are being randomized world-wide to see if apixaban reduces cardiovasular death, heart attack and stroke.
Study participants will receive study medications and related medical care at no cost. Compensation may be provided for study-related travel.
To find out more, without any obligation, contact your cardiologist.
- SOLID-TMI 52
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This study is appropriate for patients within 30 days of a heart attack or unstable angina. The subject must have at least one high risk criteria, such as age greater than 60 or diabetes. patients are randomized to darapladib or placebo. Darapladib inhibits an enzyme in the blood which increases inflammation in the coronary arteries. 14,500 patients are being randomized world-wide to see if darapladib reduces cardiovascular death, heart attack or stroke.
- HCRI DAPT
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This study is appropriate for patients who undergo placement of a drug-eluting or bare metal coronary stent for angina, unstable angina or heart attack. This study is being done at the request of FDA to answer the question of whether Plavix or Effient need to be continued along with aspirin after one year in these patients. Patients receive aspirin and Plavix or Effient for the first year. After one year, patients are randomized to receive aspirin alone or aspirin along with Plavix. 20,645 patients are being enrolled to see if continuing Plavix or Effient with the aspirin significantly decreases death, heart attack, stroke or stent thrombosis. (clot)
