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

Primary Purpose

Hypertension, Diabetes, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
telmisartan
valsartan
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Comparison of telmisartan and valsartan on neointima volume with IVUS at 8 months after zotarolimus-eluting stent implantation.

Secondary Outcome Measures

Comparison of telmisartan and valsartan on the levels of RBP-4 and inflammatory markers (hsCRP, IL-6, TNF-α, adiponectin).

Full Information

First Posted
January 11, 2008
Last Updated
September 2, 2015
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00599885
Brief Title
Comparison of Effects of Telmisartan and Valsartan on Neointima Volume in Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
telmisartan
Intervention Description
telmisartan 40-80mg once per day for 8 months
Intervention Type
Drug
Intervention Name(s)
valsartan
Intervention Description
valsartan 80-160mg once per day for 8 months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do-Sun Lim, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21700754
Citation
Hong SJ, Choi SC, Ahn CM, Park JH, Kim JS, Lim DS. Telmisartan reduces neointima volume and pulse wave velocity 8 months after zotarolimus-eluting stent implantation in hypertensive type 2 diabetic patients. Heart. 2011 Sep;97(17):1425-32. doi: 10.1136/hrt.2011.225193. Epub 2011 Jun 23.
Results Reference
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Comparison of Effects of Telmisartan and Valsartan on Neointima Volume in Diabetes

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