Vein-Coronary Atherosclerosis And Rosiglitazone After Bypass Surgery: The VICTORY Trial

Exclusion Criteria

• •AT SCREENING:
• •1. Clinically significant abnormality at screening tests \& exams.
• •2. Type 1 diabetes or history of diabetic ketoacidosis.
• •3. Uncontrolled type 2 diabetes mellitus.
• •4. Recent MI or ACS (≤ 90 days).
• •5. History of hypersensitivity to thiazolidinediones (TZD) or compounds of similar chemical structures.
• •6. Last LVEF≤ 35%.
• •7. SBP\>170mmHg or DBP\>100mmHg at screening/baseline should be appropriately treated and under control prior to randomization.
• •8. Unstable or Canadian Cardiovascular Society class III and IV angina, acute heart failure or congestive heart failure (NYHA class III and IV).
• •9. History of hepatocellular reaction/severe oedema/other potentially fluid-related AE associated with use of any TZD or PPAR-γ agonist.
• •10. Hepatic disease.
• •11. Renal dysfunction.
• •12. Anemia.
• •13. TG ≥ 10 mmol/L.
• •14. History of PCI in all SVG(s).
• •15. Known occlusion(s) of all SVG(s).
• •16. Treatment involving TZD within 3 mo prior to screening.
• •17. Chronic use (≥ 6 mo) of insulin for glycemic control at any time in the past or administration of insulin any time within the last 12 mo.
• •18. Allergy to contrast agents.
• •19. Current intake of anorectic agents or have been taken off an anorectic agent or equivalent within 3 mo prior to screening.
• •20. Patients for whom oral or injectable corticosteroids are used on a regular or recurrent basis.
• •21. Recent history/suspicion of current drug abuse or alcohol abuse within last 6 mo.
• •22. Women breast feeding, pregnant, or planning to become pregnant during conduct of trial and for 30 days after study completion.
• •23. Other illness that precludes survival.
• •24. History of malignancy within the last 5 yrs.
• •25. Concurrent participation in other investigational device or drug studies and/or having received any experimental therapeutic agents within 30 days of the screening.
• •26. Use of any investigational drug for glycemic control within 3 mo of the screening.
• •27. Patient travelling out of town/country for periods exceeding 2 mo.
• •28. Medical condition which may interfere with intake and/or absorption of study medication.
• •29. Patients unwilling or unable to comply with procedures.
• •30. Recent major surgery within 90 days of the screening.
• •AT IVUS AND ANGIOGRAPHY (VISIT 2):
• •1. PCI was performed on the target segment(s) after CABG.
• •2. Target SVG and/or target native coronary artery show ≥ 50% angiographic lesion precluding IVUS.
• •3. Thrombus/thrombus aspect in target vessels.
• •4. Target vessel has been subjected to surgical endarterectomy.