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Clinical Trial Details

Trial ID: L2828
Source ID: NCT00771004
Associated Drug: Pioglitazone
Title: Efficacy of Pioglitazone on Myocardial Function in Patients Undergoing Coronary Stent Implantation.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Oxidative Stress|Coronary Artery Disease|Type 2 Diabetes
Interventions: DRUG: Pioglitazone|DRUG: Placebo
Outcome Measures: Primary: Incidence of Cardiac Troponin I elevation (greater than 1 upper limit of normal) post-percutaneous coronary intervention with stent implantation., 24 hours post stent implantation. | Secondary: Incidence of Creatine Kinase (Myocard-type) post-percutaneous coronary intervention with stent implantation., 24 hours post stent implantation.|Mean peak values of Troponin I and Creatine Kinase (Myocard-type) post-percutaneous coronary intervention with stent implantation., Hours: 2, 6 and 12 and 24 post stent implantation.|Frequency of Doppler-detected microembolism measured by high intensity transient signals during percutaneous coronary intervention with stent implantation (sub-study Jena only)., Duration of stent implantation surgery.|Time course of Troponin I Laboratory Procedure., Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.|Time course of high-sensitive-C-Reactive Peptide Laboratory Procedure., Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.|Time course of nitrotyrosine Laboratory Procedure., Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.|Time course of Asymmetric dimethylarginine Laboratory Procedure., Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.|Time course of E-selectin Laboratory Procedure., Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.|Time course of Myoglobin Laboratory Procedure., Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.|Time course of Visfatin Laboratory Procedure., Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.|Time course of Proinsulin intact Laboratory Procedure., Visits: 1 and 7 or Final Visit.|Time course of Adiponectin Laboratory Procedure., Visits: 1 and 7 or Final Visit.
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 63
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2006-08
Completion Date: 2009-02
Results First Posted:
Last Update Posted: 2010-07-05
Locations: Frankfurt, Hessen, Germany|Kassel, Hessen, Germany|Wiesbaden, Hessen, Germany|Wuppertal, Nordrhein-Westfalen, Germany|Mainz, Rheinland-Pfalz, Germany|Jena, Thüringen, Germany|Hamburg, Germany
URL: https://clinicaltrials.gov/show/NCT00771004