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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Soon Jun Hong, Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT00599885
First received: January 11, 2008
Last updated: March 1, 2014
Last verified: March 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Korea University Anam Hospital:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: September 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599885

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

No publications provided by Korea University Anam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soon Jun Hong, Associate professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00599885     History of Changes
Other Study ID Numbers: TELLME, TELLME trial
Study First Received: January 11, 2008
Last Updated: March 1, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Hypertension
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Valsartan
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014