Gill Heart Institute – current research studies

For more information about research at Gill Heart Institute, visit the Cardiovascular Research Center

COMPASS 2

Principal Investigator: David Booth, MD
Sponsor: Actelion Pharmaceuticals Ltd.

For Males or Females > 12 years of age with symptomatic Pulmonary Arterial Hypertension

Objective: to demonstrate that the combination of bosentan and Sildenafil is better than Sildenafil alone

CHAMPION - PCI

Principal Investigator: Steve Steinhubl, MD
Sponsor: The Medicines Company

For Males or Females > 18 years of age who are scheduled to undergo a heart catheterization/Percutaneous Coronary Intervention urgent or non-urgent

Objective: To demonstrate that Cangrelor, is superior, or at least non-inferior to Plavix

CAPTURE 2

Principal Investigator: Debabrata Mukherjee, MD
Sponsor: Abbott Vascular

For Males or Females undergoing carotid stenting
Objective: Post-market surveillance to document clinical outcomes involving the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System (EPS)

SHINE

Principal Investigator: Debabrata Mukherjee, MD
Sponsor: Sanofi Aventis

For Males or Females > 21 years old who present with symptoms of a heart attack and undergo a heart catheterization/Percutaneous Coronary Intervention

Objective: To evaluate the dose effect of Hexadecasaccharide, a ATIII-dependant inhibitor of coagulation factors Xa & IIa

APPRAISE

Principal Investigator: Steve Steinhubl, MD
Sponsor: Bristol-Myers Squibb Pharmaceutical Research Institute (BMS)

For Men or Women between the ages of 18 & 90 who have experienced Acute Coronary Syndrome in the past seven days

Objective: to evaluate the safety of 4 doses of apixaban, an inhibitor of factor Xa as compared to placebo over a 26 week treatment period. To determine the optimal dose and regimen of apixaban inhibitor of factor Xa

IMPROVE - IT

Principal Investigator: Steve Steinhubl, MD
Sponsor: Schering Plough Research Institute

For Men or Women > 50 years of age who have experienced Acute Coronary Syndrome in the past 10 days

Objective: To evaluate the clinical benefit of Vytorin compared to Zocor in patients who are clinically stable after Acute Coronary Syndrome

CRESCENDO

Principal Investigator: Steve Steinhubl, MD
Sponsor: Sanofi Aventis

For Men or Women aged 55 or older who have a presence of abdominal obesity and cardiovascular risk factors such as previous heart attack, Type 2 diabetes or stroke

Objective: to demonstrate the efficacy of Rimonabant vs. Placebo for reducing the risk of heart attack, stroke, or cardiovascular death in patients with abdominal obesity at increased risk for such events

PREMIUM

Principal Investigator: John Gurley, MD
Sponsor: AGA Medical

For Men and Women ages 18 to 55 who have been diagnosed as having migraine headaches and demonstrate the presence of a patent foramen ovale (PFO) and have failed or shown to be refractory or unresponsive or contraindicated to two previous commonly accepted medications

The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in subjects who are refractory to medical treatment. The

AMPLATZERÆ PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale (PFO) in subjects who have suffered from disabling migraine headaches.

FREEDOM

Principal Investigator: Debabrata Mukherjee, MD
Sponsor: NIH

For Men and Women 18 years or older with Type 1 or Type 2 Diabetes mellitus and coronary artery disease

Objective: To evaluate whether Percutaneous Coronary Intervention with drug-eluting stenting is more or less effective than the existing standard of care, coronary artery bypass surgery (CABG)

PLATO

Principal Investigator: Steve Steinhubl, MD
Sponsor: AstraZeneca Pharmaceuticals

For Men or Women at least 18 years of age presenting with Acute Coronary Syndrome

Objective: to test the hypotheses that an investigational drug, AZD6140, is superior to Plavix for the prevention of vascular events in patients with Acute coronary Syndrome