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| Sponsor: | Korea University Anam Hospital |
|---|---|
| Information provided by: | Korea University Anam Hospital |
| ClinicalTrials.gov Identifier: | NCT00599885 |
Purpose
People with diabetes mellitus are more prone to coronary heart disease, stroke, and peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk factor for the progression of coronary artery disease. Several studies have been reported that diabetes increased the risk of cardiovascular mortality in both men and women. With the introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later months have reduced dramatically in several studies. However, even with DESs, diabetic patients showed increased rates of restenosis and late loss index compared with nondiabetic patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era of DESs, no study has compared the effects of telmisartan and valsartan on neointima volume with intravascular ultrasound (IVUS) at 8 months after zotarolimus-eluting stent implantation in hypertensive type 2 diabetic patients. Telmisartan, which is well-known for its selective peroxisome proliferator-activated receptor (PPAR)-γ activity with its anti-inflammatory and antiproliferative properties, could be an appropriate therapeutic option for treating hypertensive diabetic patients with significant coronary artery diseases requiring stent implantation. In contrast, valsartan is an angiotensin receptor blocker with negligible PPAR-γ activity. Increasing interest remains in the identification of systemic pharmacological therapies to prevent coronary restenosis especially in diabetic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Diabetes Coronary Artery Disease |
Drug: telmisartan Drug: valsartan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
| Estimated Enrollment: | 72 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: telmisartan
telmisartan 40-80mg once per day for 8 months
|
| 2: Active Comparator |
Drug: valsartan
valsartan 80-160mg once per day for 8 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Korea, Republic of | |
| Korea University Anam Hospital | |
| Seoul, Korea, Republic of, 136-705 | |
| Study Chair: | Do-Sun Lim, MD, PhD | Korea University Anam Hospital |
More Information
| Responsible Party: | Korea University Anam Hospital ( Soon Jun Hong ) |
| Study ID Numbers: | TELLME, TELLME trial |
| Study First Received: | January 11, 2008 |
| Last Updated: | August 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00599885 History of Changes |
| Health Authority: | Korea: Food and Drug Administration |
|
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Arteriosclerosis Antihypertensive Agents |
Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Coronary Disease Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Glucose Metabolism Disorders Valsartan Coronary Artery Disease Hypertension |