Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Type 2 Diabetes and Diabetic Nephropathy
NCT ID: NCT01743014
Last Updated: 2012-12-06
Study Results
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.
UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2012-07-31
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ramipril
Ramipril 10 mg tablets. Each dose will be taken orally with water once daily.
Ramipril
Patients will receive 10 mg ramipril throughout the study. Each dose will be taken orally once daily. The duration of treatment with ramipril is 26 weeks
clopidogrel and ramipril
clopidogrel 75mg tablet and ramipril 10mg. Each drug will be taken orally with water once daily
Ramipril
Patients will receive 10 mg ramipril throughout the study. Each dose will be taken orally once daily. The duration of treatment with ramipril is 26 weeks
Clopidogrel
12 weeks treatment with ramipril 10 mg and clopidogrel 75 mg once daily followed by a 2 week wash out period for clopidogrel and subsequently additional 12 weeks treatment wit both drugs after cross over.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ramipril
Patients will receive 10 mg ramipril throughout the study. Each dose will be taken orally once daily. The duration of treatment with ramipril is 26 weeks
Clopidogrel
12 weeks treatment with ramipril 10 mg and clopidogrel 75 mg once daily followed by a 2 week wash out period for clopidogrel and subsequently additional 12 weeks treatment wit both drugs after cross over.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Blood pressure ≤130/80 mmHg
* LDL (Low Density Lipoproteins) \<100 mg/dl
* Informed consent
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aristotle University Of Thessaloniki
OTHER
AHEPA University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vaia Bougatsa
Medical Doctor-Resident of Internal Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fotios S Iliadis, Lecturer of Internal Medicine
Role: STUDY_DIRECTOR
AHEPA University Hospital/ Aristotle University of Thessaloniki
Vaia F Bougatsa, Resident of Internal Medicine
Role: PRINCIPAL_INVESTIGATOR
AHEPA University Hospital/ Aristotle University of Thessaloniki
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AHEPA University Hospital
Thessaloniki, Thessaloniki, Greece
Aristotle University of Thessaloniki/ AHEPA University Hospital
Thessaloniki, Thessaloniki, Greece
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Fotios S Iliadis, Lecturer of Internal Medicine
Role: CONTACT
Phone: +306974960728
Email: [email protected]
Vaia F Bougatsa, Resident of internal medicine
Role: CONTACT
Phone: +306944334265
Email: [email protected]
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Fotios S Iliadis, Lecturer of Internal Medicine
Role: primary
Vaia F Bougatsa, Resident of Internal Medicine
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15/10-7-2012
Identifier Type: -
Identifier Source: org_study_id