Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction i… (NCT01743014) | Clinical Trial Compass
UnknownPhase 4
Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Type 2 Diabetes and Diabetic Nephropathy
Greece60 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 opi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Asymmetric dimethylarginine (ADMA) blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy
Timeframe: Baseline to week 12 and week 14 to week 26
2
Changes in High-sensitivity C-reactive protein (HsCRP) blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy
Timeframe: Baseline to week 12 and week 14 to week 26
3
Changes in soluble CD40 Ligand (sCD40L)blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy
Timeframe: Baseline to week 12 and week 14 to week 26
4
Changes in urine 8-isoprostane-F2 levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy
Timeframe: Baseline to week 12 and week 14 to week 26
5
Reduction in albumine to creatine ratio after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy
Timeframe: Baseline to week 12 and week 14 to week 26