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Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Type 2 Diabetes and Diabetic Nephropathy

Information source: AHEPA University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Type 2; Diabetic Nephropathy; Vascular Disease

Intervention: Ramipril (Drug); Clopidogrel (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: AHEPA University Hospital

Official(s) and/or principal investigator(s):
Fotios S Iliadis, Lecturer of Internal Medicine, Study Director, Affiliation: AHEPA University Hospital/ Aristotle University of Thessaloniki
Vaia F Bougatsa, Resident of Internal Medicine, Principal Investigator, Affiliation: AHEPA University Hospital/ Aristotle University of Thessaloniki

Overall contact:
Fotios S Iliadis, Lecturer of Internal Medicine, Phone: +306974960728, Email: iliadis@med.auth.gr

Summary

The purpose of this study is to determine whether the combination with ramipril and clopidogrel leads to further improvement of endothelial function, reduction of oxidative stress and reduction of vascular inflammation, compared with ramipril monotherapy, in patients with Diabetes Mellitus type 2 and diabetic nephropathy.

Clinical Details

Official title: A Prospective, Randomized, Two Period, With an Intermediate Wash Out Period, Cross-over Study to Compare the Effects of Either Combined Therapy With Ramipril and Clopidogrel or Ramipril Monotherapy on Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Patients With Type 2 Diabetes and Diabetic Nephropathy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Changes in Asymmetric dimethylarginine (ADMA) blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy

Changes in High-sensitivity C-reactive protein (HsCRP) blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy

Changes in soluble CD40 Ligand (sCD40L)blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy

Changes in urine 8-isoprostane-F2 levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy

Reduction in albumine to creatine ratio after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy

Secondary outcome:

Changes in ADMA blood levels after treatment with ramipril

Increase of Glomerular Filtration Rate (GFR) after combined treatment with ramipril and clopidogrel and after ramipril monotherapy

Change from baseline in carotid intima-media thickness after combined therapy with ramipril and clopidogrel and after ramipril monotherapy

Detailed description:

- Cardiovascular disease is the leading cause of deaths in diabetic population with

diabetic nephropathy.

- Pharmacologic therapy for patients with diabetes and hypertension should be with a

regimen that includes either an angiotensin-converting-enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB)

- Diabetic patients at increased cardiovascular risk should receive an antiplatelet agent

for primary prevention. Methods: An open label,randomized, two period cross-over design study, involving patients with type 2 diabetes and diabetic nephropathy. After a 4 weeks wash out period for ACE inhibitors or Angiotensin receptor blockers (week 0, baseline) 60 patients will be randomized to receive ramipril(10 mg) only or ramipril (10 mg) and clopidogrel (75mg) for 12 weeks exchanging their treatment for a further 12 weeks, after a 2 week wash out period for clopidogrel. Patients will be examined and measurements will be taken at baseline (week 0), and at the end of 12, 14, and 26 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: type 2 diabetes patients with diabetic nephropathy in the range of micro- or macroalbuminuria and

- HbA1c(glycosylated haemoglobin A1c <7%

- Blood pressure ≤130/80 mmHg

- LDL (Low Density Lipoproteins) <100 mg/dl

- Informed consent

Exclusion Criteria:

- patients with diabetic nephropathy and estimated GFR <30ml/min with Modification of

Diet in Renal Disease equation (MDRD equation)

- baseline potassium > 5. 2 meq/L

- patients with nephrotic proteinuria defined as albumine to creatinine ratio (ACR)>

3. 5 g/g or as proteinuria >3. 5 g per 1. 73 m2 per 24 hours

- history or evidence of non-diabetic kidney disease

- history of stroke, peripheral artery disease, coronary artery disease

- history or evidence of a secondary form of hypertension

- history of severe hepatic failure, malignancy, severe endocrinopathy,autoimmune

disease or chronic inflammatory disease

- any known bleeding or platelet disorder or platelets <100. 000/μL

- heart failure in New York Heart Association(NYHA) functional class II-IV

- inability or unwillingness on the part of the patient to sign the Patient Consent

Form

- known hypersensitivity to ramipril or to clopidogrel

- Women of child-bearing potential

- use of oral anticoagulants or other antithrombotic treatment

- use of glitazones

- patients receiving statins should be on a stable dose of at least 3 months prior to

study initiation and dose should be constant during the study

- any surgical or medical condition which in the opinion of the investigator may expose

the patient to a higher risk in participation in the study

Locations and Contacts

Fotios S Iliadis, Lecturer of Internal Medicine, Phone: +306974960728, Email: iliadis@med.auth.gr

AHEPA University Hospital, Thessaloniki 546 36, Greece; Recruiting
Fotios S Iliadis, Lecturer of Internal Medicine, Phone: +302310993587, Email: iliadis@med.auth.gr
Vaia F Bougatsa, Resident of Internal Medicine, Phone: +306944334265, Email: vaiabou@yahoo.gr

Aristotle University of Thessaloniki/ AHEPA University Hospital, Thessaloniki, Greece; Recruiting
Vaia F Bougatsa, MD, Principal Investigator

Additional Information

Starting date: July 2012
Last updated: December 4, 2012

Page last updated: August 23, 2015

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