A Multi-center Randomized Double-Blind Trial Comparing Rosiglitazone to Placebo for the Prevention of Atherosclerosis Progression after Coronary Bypass Surgery in Diabetic Patients

Cardiometabolic effects of rosiglitazone in patients with type 2 diabetes and coronary artery bypass grafts: A randomized placebo-controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54136716

Enrollment

280

Registered

2005-02-21

Start date

2003-04-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Circulatory System Atherosclerosis in diabetic patients

Interventions

A multi-center randomized double-blind trial comparing rosiglitazone to placebo. At baseline, patients undergo 1. Angiography and intravascular ultrasound examinations

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stable diabetic patients (HbA1c inferior or equal to 9.0%) with previous coronary bypass surgery (1-10 years) and a suitable 40 mm segment in a vein graft and a 20 mm segment in native coronary artery.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study will be the change (12-month intravascular ultrasound [IVUS] ? Baseline IVUS) in plaque volume in a segment of at least 40 mm in one SVG as measured by IVUS.	—

Secondary

Measure	Time frame
IVUS: 1. The change in plaque volume from baseline to 12 month follow-up in a segment of anastomosed coronary artery of at least 20 mm 2. The changes from baseline to 12-month follow-up in lumen volume and in total vessel volume in the =40 mm SVG segment and in the =20 mm coronary segment 3. The changes from baseline to 12-month follow-up in lumen area, plaque area, and total vessel area in the =40 mm SVG segment and in the =20 mm coronary segment 4. The changes from baseline to 12-month follow-up in qualitative plaque characterization in the =40 mm SVG segment and in the =20 mm coronary segment 5. The proportion of patients showing atherosclerosis changes (progression/regression) 6. The proportion of patients showing atherosclerosis changes 'concordance', i.e. progression in SVG segment and coronary segment and atherosclerosis 'discordance', i.e. progression, stabilization or regression noted in one of the analyzed segment not found in the other analyzed segment Angiography: 1. The proportion of patients showing new occlusions in native coronary arteries or SVGs 2. The changes in reference and minimum lumen diameters of the SVG as assessed by quantitative coronary angiography (QCA) 3. The per-patient percentage of initially patent SVGs that had significant progression of atherosclerosis at the site of greatest change at follow-up Metabolic risk factors: Changes from baseline to 6 and 12 months of indices for comprehensive lipid, thrombosis and pro-inflammatory profiles as well as glucose-insulin homeostasis, microalbuminuria, adhesion molecules, adipokines, and other markers relevant to the evaluation and management of cardiovascular disease risk Body composition and distribution parameters: 1. Changes in abdominal areas and volumes of adipos	—

Measure

Time frame

IVUS: 1. The change in plaque volume from baseline to 12 month follow-up in a segment of anastomosed coronary artery of at least 20 mm 2. The changes from baseline to 12-month follow-up in lumen volume and in total vessel volume in the =40 mm SVG segment and in the =20 mm coronary segment 3. The changes from baseline to 12-month follow-up in lumen area, plaque area, and total vessel area in the =40 mm SVG segment and in the =20 mm coronary segment 4. The changes from baseline to 12-month follow-up in qualitative plaque characterization in the =40 mm SVG segment and in the =20 mm coronary segment 5. The proportion of patients showing atherosclerosis changes (progression/regression) 6. The proportion of patients showing atherosclerosis changes 'concordance', i.e. progression in SVG segment and coronary segment and atherosclerosis 'discordance', i.e. progression, stabilization or regression noted in one of the analyzed segment not found in the other analyzed segment Angiography: 1. The proportion of patients showing new occlusions in native coronary arteries or SVGs 2. The changes in reference and minimum lumen diameters of the SVG as assessed by quantitative coronary angiography (QCA) 3. The per-patient percentage of initially patent SVGs that had significant progression of atherosclerosis at the site of greatest change at follow-up Metabolic risk factors: Changes from baseline to 6 and 12 months of indices for comprehensive lipid, thrombosis and pro-inflammatory profiles as well as glucose-insulin homeostasis, microalbuminuria, adhesion molecules, adipokines, and other markers relevant to the evaluation and management of cardiovascular disease risk Body composition and distribution parameters: 1. Changes in abdominal areas and volumes of adipos

—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026