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Coronary Artery Disease and Interventional
Cardiology Clinical Trials



TRA 2o P TIMI 50

A Multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of SCH 530348 in addition to standard of care in subjects with a history of atherosclerotic disease:  Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events.

  • The primary objective is to evaluate the hypothesis that SCH 530348 added to standard of care will reduce the incidence of atherothrombotic ischemic events relative to standard of care alone.
  • Subjects must have evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular system as evidenced by MI, ischemic stroke, intermittent claudication (ABI <0.85, amputation, bypass or angioplasty)
  • Periodic clinic visit follow-up for 36 months
  • The primary investigator is Phillip Horwitz, MD
  • The study coordinator is Ronda Wilson, RN (319) 353-6675

PLATO - AZD6140 vs. Clopidogrel

Randomized, double-blind, parallel group, phase 3, efficacy and safety study of AZD6140 compared with Clopidogrel for prevention of vascular events in patients with Non-St or ST elevation acute coronary syndromes (ACS).

  • The objective of this study is to test the hypothesis that AZD6140 is superior to clopidogrel for the prevention of vascular events in patients with non-ST or ST elevation acute coronary syndromes (ACS)
  • Subjects will be randomized to AZD6140 or Clopidogrel
  • The primary investigator is Phillip Horwitz, MD
  • The study coordinator is Kim Reysack, RN, 319-353-6675


CHAMPION PLATFORM - IV Cangrelor

Randomized, double-blind, placebo-controlled, parallel group clinical trial comparing treatment with cangrelor (in combination with usual care) to usual care, in subjects who require percutaneous coronary intervention (PCI).

  • The objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring PCI.
  • Subjects with coronary atherosclerosis (excluding ST elevation MI) requiring percutaneous coronary intervention (with or without stent)
  • Patients will be randomized to receive IV cangrelor or placebo
  • The primary investigator is Phillip Horwitz, MD
  • The study coordinator is Kim Reysack, RN, 319-353-6675


CHAMPION PCI – IV Cangrelor

Randomized, double-blind, double-dummy, active-controlled, parallel group clinical trial comparing Cangrelor to clopidogrel in subjects who require percutaneous coronary intervention (PCI)

  • The objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring (PCI)
  • Subjects with coronary atherosclerosis requiring percutaneous coronary intervention (with or without stent) (including ST elevation MI)
  • Patients will be randomized to receive IV cangrelor or clopidogrel immediately prior to PCI
  • Patient follow-up by phone through one year
  • The primary investigator is Phillip Horwitz, MD
  • The study coordinator is Kim Reysack, RN (319) 353-667

CORAL - Renal Artery Stent for Hypertension

Cardiovascular Outcomes in Renal Atherosclerotic lesions.

  • This study is designed to test the hypothesis that stenting renal artery stenoses in patients with systolic hypertension reduces the incidence of adverse cardiovascular and renal events compared with medical therapy alone.
  • Patients will be randomized after angiography to either medical therapy or medical therapy with renal artery stenting and be closely monitored for blood pressure control and management of other risk factors from 3-to-5 years.
  • The primary investigator is James Rossen, MD
  • The study coordinator is Ronda Wilson, RN, 319-353-6675


PREMIUM - PFO Closure for Migraine Headaches

Randomized, controlled, double-blind study to evaluate incidence of headache reduction in subjects with migraine and PFO using the AMPLATZER PFO Occluder compared to medical management over a 12-month period.

  • Subjects will be randomized to the device group or placebo procedure group.
  • Follow-up with neurologist once a month for 6 months, then every other month until 12 months post-procedure.
  • Follow-up with cardiologist 1 month post-procedure.
  • The primary investigator is Phillip Horwitz, MD
  • The study coordinator is Ronda Wilson, RN, 319-353-6675

CHOICE- Carotid artery stent and embolic protection systems

A prospective, non-randomized, multi-center, descriptive, post-market study evaluating outcomes through the collection of clinical evidence for two carotid artery stent systems and two embolic protection systems

  • Patients who require carotid stents and/or embolic protection systems
  • Follow-up with within 24 hours and 30 days post-procedure
  • The primary investigator is James Rossen, M.D.
  • The study coordinator is Amy Ollinger, RN, BSN (319) 353-6675

PFO ACCESS REGISTRY

Main object is to allow access to the APLATZER PFO Occluder in subjects with a patent foramen ovale (PFO) who have already experienced at least two strokes due to presumed embolism through a PFO and who have failed conventional drug therapy.

  • Patients must be on antiplatelet or anticoagulant therapy
  • Patients will be on antiplatelet / anticoagulation therapy for 6 months post procedure.
  • Follow-up visits in the Cardiology Clinic at 6 months and 1 year
  • The primary investigator is Phillip Horwitz, M. D.
  • The study coordinator is Ronda Wilson, RN (319) 353-6675

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Last modification date: Wed Jun 11 13:41:58 2008
URL: http://www.uihealthcare.com /depts/uiheartcare/coronarycardiotrials.html