Comparison of Effects of Telmisartan and Valsartan on Neointima Volume in Diabetes
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...
Brief Summary
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
- Study Primary Completion Date: July 2008
Intervention(s) in this Clinical Trial
- Drug: telmisartan
- telmisartan 40-80mg once per day for 8 months
- Drug: valsartan
- valsartan 80-160mg once per day for 8 months
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Comparison of telmisartan and valsartan on neointima volume with IVUS at 8 months after zotarolimus-eluting stent implantation.
- Time Frame: 8 month follow-up
Safety Issue?: No
- Time Frame: 8 month follow-up
Secondary Measures
- Comparison of telmisartan and valsartan on the levels of RBP-4 and inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
- Time Frame: 8 months follow-up
Safety Issue?: No
- Time Frame: 8 months follow-up
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Age: 18 years and above
- Gender eligible for study: both
- Hypertensive diabetic patients either previously diagnosed or newly found.
- Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 80 mmHg for newly found hypertensive patients.
- Fasting blood glucose ≥ 126 mg/dl or PP2 blood glucose ≥ 200 mg/dl for newly found diabetes.
- Patients with significant de novo coronary artery disease (diameter stenosis > 70%) requiring stent implantation (angina pectoris and/or exercise-induced ischemia).
- Patients with informed consent.
Exclusion Criteria:
- Acute ST-segment elevation myocardial infarction (MI), CTO lesions, left main lesions
- Diabetic patients with the use of thiazolidinediones within 3 months
- Previous history of PCI or bypass surgery
- Patients with any contraindications to the treatment of telmisartan or valsartan
- Pregnant or lactating patients
- Chronic alcohol or drug abuse
- Hepatic dysfunction
- Renal dysfunction
- Heart failure (EF < 50%)
- Expected life expectancy of < 1 year
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Korea University Anam Hospital Other
Overall Clinical Trial Officials and Contacts
Do-Sun Lim, MD, PhD Study Chair Korea University Anam Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00599885
Study ID Number: TELLME
ClinicalTrials.gov Identifier: NCT00599885
Health Authority: Korea: Food and Drug Administration
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00599885
