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 monotherapyChanges 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 ramiprilIncrease 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
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