Status:
UNKNOWN
PIoglitazone for PrEvention of Restenosis in Diabetic Patients
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Coronary Atherosclerosis
Coronary Restenosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Restenosis requiring reintervention is still a limitation of percutaneous coronary angioplasty. Despite the use of Drug eluting stent (DES), the rate of restenosis remains 7% to 16% in diabetic patien...
Detailed Description
2.Design This is a randomised, placebo-controlled, double-blinded, multicenter centre study.The patients' clinical data will be recorded on case report forms (CRF). 3.Aim of the study To evaluate the...
Eligibility Criteria
Inclusion
- I5.1 Inclusion criteria
- Patients must be previously diagnosed with type 2 diabetes with documented treatment with insulin, oral hypoglycemics, or diet controlled by medical history. (Undocumented or newly diagnosed diabetics must fulfill the American Diabetes Association Criteria-Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Diabetes Care 2003;26:S5-20)).
- Diagnosis of angina pectoris defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
- Patients with "de novo" coronary lesion (any length) who are eligible for coronary revascularization;
- Target lesion is ≥2.5 mm to ≤3.5mm in diameter (visual estimate);
- Target lesion stenosis is ≥50% (visual estimate);
- Male or Female age \>18 years old;
- Patients with one or more lesions to be treated with a sirolimus eluting stent (Cypher, Cordis);
- Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board.
- At least one lesion must be a complex lesion (see below for details)
- 2 Exclusion criteria
- Patients under age 18 years old;
- Patient has experienced an ST-segment elevation myocardial infarction within the preceding 30 days;
- Active liver disease (ALT\>2.5 times upper limit of normal);
- Impaired renal function (creatinine ≥2.5 mg/dL);
- Previous brachytherapy of target vessel;
- Lesion of the Left Main trunk \> 50%;
- Target lesion is in a saphenous venous graft or internal mammary graft;
- Target lesion is due to restenosis ;
- Recipient of heart transplant;
- Women who are pregnant or who have the potential to become pregnant during the study;
- Patients with life expectancy of less than one year or factors making clinical follow-up difficult;
- Patients with bleeding diathesis in whom anticoagulant or antiplatelet drug is contraindicated;
- Patient with intolerance/contraindication to Aspirin or Ticlopidine/Clopidogrel or pioglitazone treatment;
- Currently participating in an investigational drug or another device study;
- Patients with leukopenia;
- Patients with neutropenia;
- Documented peptic ulcer or gastric/intestinal bleeding in the last 6 months;
- Patients with thrombocytopenia.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00376870
Start Date
July 1 2008
End Date
April 1 2011
Last Update
August 1 2008
Active Locations (2)
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1
Policlinico di Tor Vergata
Rome, Italy, 00133
2
Policlinico di Tor Vergata
Rome, Italy, 00133