Clinical Trial News

From staff reports

Claudication: Exercise versus Endoluminal Revascularization (CLEVER) is a phase III, randomized, interventional study to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency and intermittent claudication. Supervised exercise rehabilitation has been shown to be of value to individuals with peripheral arterial disease and claudication, but it is not often prescribed for claudication, is not reimbursed by Medicare, and is rarely covered by private insurance. Stent revascularization for patients with intermittent claudication, although controversial for patients who do not have ischemic pain at rest or limb-threatening ischemia, has shown improved benefits on exercise capacity and walking times. This multicenter study plans to randomize patients to four groups: optimal medical care/pharmacotherapy, supervised exercise rehabilitation/pharmacotherapy, stent/pharmacotherapy, and stent/supervised exercise/pharmacotherapy. The primary outcomes are a change in the maximum walking duration score, changes in free-living daily activity levels, participant-perceived quality of life, and cost-effectiveness (all measured at 18 months). The study is sponsored by the National Heart, Lung, and Blood Institute and began in August 2006, with a total expected enrollment of 252 patients. The ClinicalTrials.gov identifier is NCT00132743.

Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery is a randomized, interventional single-blind safety/efficacy study to determine if aggressive intra- and postoperative management of blood glucose can decrease cardiovascular and infectious complications in diabetic and nondiabetic patients undergoing vascular surgery. Patients will be randomized to tight versus standard blood glucose control regimens. In tight control, the target is 100-150 mg/dL, and if three consecutive hourly readings are above target, insulin infusion will be provided, with strict monitoring and adjustment during and after surgery. In the standard sliding-scale insulin group, patients will receive an insulin bolus if blood sugars top 150 mg/dL, with monitoring every 4 hours. Primary outcomes are perioperative cardiovascular morbidity and mortality. Secondary outcomes are incidence of wound infections, other organ morbidity, and mortality. The study is sponsored by Beth Israel Deaconess Medical Center in Boston and began in March 2006, with a total expected enrollment of 1986 patients. The ClinicalTrials.gov identifier is NCT00328094.

Prevention of endoleaks using autologous platelet gel on unruptured abdominal aortic aneurysms is a non-randomized, interventional open label safety study to determine if a new approach to endoleaks is safe before initiating a test for efficacy. Blood drawn from the patient will be separated and platelet rich plasma and autologous thrombin will be reinjected in order to form a platelet gel. Primary outcome is the safety of the procedure as assessed by distal embolism, colic necrosis, and aneurysm rupture. Secondary outcomes include the rate and type of endoleaks at one month and the rate of complications. The study is currently recruiting patients with a start date of September 2006, with a total expected enrollment of 10 patients. The study is sponsored by Renes University Hospital, France, and Medtronic. The ClinicalTrials.gov identifier is NCT00372138.

Caffeine and intermittent claudication is a randomized, interventional double-blind, placebo-controlled phase III study to determine if caffeine has a safe and beneficial effect on walking distance, metabolic factors, and quality of life in patients with peripheral arterial disease. A total of 80 patients with PAD, Fontaine, stage II will be enrolled, of whom 40 will be revascularized. Patients will be randomized to 6 mg/kg caffeine or placebo over a 12-week period. Primary outcomes include maximum walking distance, increased endothelial growth factors VGF, FGF, and quality of life. Secondary outcomes include pain-free walking distance, strength of knee extension, postural stability, and walking impairment. The study has an expected starting date of September 2006 with an expected completion in March 2009. The study is sponsored by the University of Aarhus, Herning Hospital and Vilborg Hospital, Denmark. The ClinicalTrials.gov identifier is NCT00388128.

Exercise therapy to treat adults with abdominal aortic aneurysms is a randomized, interventional open label, active control, parallel assignment efficacy study to determine if an appropriate exercise program can limit the growth of small AAAs in older individuals. The primary outcome is growth rate of AAAs as measured at year 3. Participants between age 55 and 80 years will be divided into 3 individual projects. Project 1 will enroll 1400 individuals with newly diagnosed small AAAs. Project 2 will enroll 1000 individuals with unknown aortic size and previously tested exercise capacity. Project 3 will enroll 340 patients from project 1 for assignment to either exercise (supervised aerobic exercise 3 days per week) or normal activity groups. The study is being sponsored by the National Heart, Lung, and Blood Institute and is scheduled to begin in November 2006, and has a total expected enrollment of 2400 patients. The ClinicalTrials.gov identifier is NCT00349947.