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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Valsartan and Aliskiren on Hemostatic Indices in Hypertensive Diabetics

NCT01095822

Diabetes Mellitus

UNKNOWN PHASE4

Valsartan for Suppression of Plaque Volume and Restenosis After Drug-Eluting Stent

NCT00589732

Coronary Artery Disease

COMPLETED PHASE4

New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering

NCT01609959

Hypertension

COMPLETED PHASE4

Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus

NCT00241085

PROTEINURIA Hypertension Type 2 Diabetes

COMPLETED PHASE4

1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy

NCT00153023

Diabetic Nephropathies Hypertension

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Diabetes Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type ACTIVE_COMPARATOR

telmisartan

Intervention Type DRUG

telmisartan 40-80mg once per day for 8 months

2

Group Type ACTIVE_COMPARATOR

valsartan

Intervention Type DRUG

valsartan 80-160mg once per day for 8 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

telmisartan

telmisartan 40-80mg once per day for 8 months

Intervention Type DRUG

valsartan

valsartan 80-160mg once per day for 8 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No