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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599885
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : September 3, 2015
Information provided by (Responsible Party):
Soon Jun Hong, Korea University Anam Hospital

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.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Coronary Artery Disease Drug: telmisartan Drug: valsartan Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : September 2007
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: telmisartan
telmisartan 40-80mg once per day for 8 months

Active Comparator: 2 Drug: valsartan
valsartan 80-160mg once per day for 8 months

Primary Outcome Measures :
  1. Comparison of telmisartan and valsartan on neointima volume with IVUS at 8 months after zotarolimus-eluting stent implantation. [ Time Frame: 8 month follow-up ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599885

Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Study Chair: Do-Sun Lim, MD, PhD Korea University Anam Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Soon Jun Hong, Associate professor, Korea University Anam Hospital Identifier: NCT00599885     History of Changes
Other Study ID Numbers: TELLME
TELLME trial
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action