SIMPADICO - Study of Immune Modulation Therapy in Peripheral Arterial Disease and Intermittent Claudication Outcomes
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|ClinicalTrials.gov Identifier: NCT00111826|
Recruitment Status : Terminated
First Posted : May 26, 2005
Last Update Posted : March 31, 2010
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Arterial Occlusive Diseases Intermittent Claudication||Device: Celacade™ system||Phase 3|
SIMPADICO was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 553 patients with claudication at 50 sites in Canada and the United States. The mean (±SD) patient age was 67±10 years; 72% were males. The duration of claudication was 6.0±6.1 years at entry; 91% had a history of smoking and 34% were current smokers; 36.5% had diabetes. Resting ABI was 0.59+0.14; baseline ICD was 132±104 and ACD 307±209 meters. Results showed that there was no increase in ACD or ICD at 26 weeks with immune modulation therapy (IMT using the Celacade™ system, Vasogen Inc.) compared to placebo and no measurable improvement in quality of life with IMT compared to placebo. However, there was a significant decrease in CRP (high sensitivity assay) in) in the IMT group compared to the placebo group. Conclusion: Immune modulation therapy did not improve walking distance in patients with symptomatic peripheral arterial disease but the decrease in CRP suggests a biologic effect of IMT and will warrant further study.
Reference: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Immune Modulation Therapy in Patients with Symptomatic Peripheral Arterial Disease: The SIMPADICO Trial. Author: Jeffrey W. Olin, Mount Sinai School of Medicine, New York, NY. Presented at Smaller Trial Late-Breaking Clinical trials I, Sunday March 12, 2006. American College of Cardiology 55th Annual Scientific Sessions, March 11-14, 2006, Atlanta, GA.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of the Celacade™ System in Improving Walking Distance in Patients With Intermittent Claudication Secondary to Peripheral Arterial Disease|
|Study Start Date :||January 2003|
|Estimated Study Completion Date :||December 2005|
- Absolute claudication distance (ACD)
- Health-related quality of life
- Functional status
- Combined incidence of peripheral arterial disease (PAD)-related clinical outcomes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111826
|Study Director:||Michael E Shannon, MD||Vasogen Inc.|