Comparison of Effects of Telmisartan and Valsartan on Neointima Volume in Diabetes

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599885
• Other study ID #: TELLME
• Secondary ID: TELLME trial
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2008
• Last updated: September 2, 2015
• Start date: September 2007

Study information

• Verified date: September 2015
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Hypertension
• Myocardial Ischemia

Intervention

Drug:
• telmisartan
telmisartan 40-80mg once per day for 8 months
• valsartan
valsartan 80-160mg once per day for 8 months

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of telmisartan and valsartan on neointima volume with IVUS at 8 months after zotarolimus-eluting stent implantation.		8 month follow-up	No
Secondary	Comparison of telmisartan and valsartan on the levels of RBP-4 and inflammatory markers (hsCRP, IL-6, TNF-a, adiponectin).		8 months follow-up	No