Comparison of Effects of Telmisartan and Valsartan on Neointima Volume in Diabetes
Information source: Korea University Anam Hospital
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Diabetes; Coronary Artery Disease
Intervention: telmisartan (Drug); valsartan (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Korea University Anam Hospital Official(s) and/or principal investigator(s):
Do-Sun Lim, MD, PhD, Study Chair, Affiliation: Korea University Anam Hospital
Overall contact:
Soon Jun Hong, MD, PhD, Phone: 82-2-920-6646, Email: psyche94@gmail.com
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.
Clinical Details
Study design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Primary outcome: Comparison of telmisartan and valsartan on neointima volume with IVUS at 8 months after zotarolimus-eluting stent implantation.
Secondary outcome: Comparison of telmisartan and valsartan on the levels of RBP-4 and inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Soon Jun Hong, MD, PhD, Phone: 82-2-920-6646, Email: psyche94@gmail.com
Korea University Anam Hospital, Seoul 136-705, Korea, Republic of; Recruiting
Sang Yup Lim, MD, PhD, Phone: 82-2-920-6702, Email: vnlover@hanmail.net
Additional Information
Starting date: September 2007
Last updated: January 24, 2008
|
