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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 September 2016 |
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Main ID: |
NCT02895113 |
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Date of registration:
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04/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Aspirin and Renal Disease Progression in Patients With Type 2 Diabetes
LEDA |
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Scientific title:
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Effect of Aspirin on Renal Disease Progression in Patients With Type 2 Diabetes: a Multicentre Double-blind, Placebo-controlled, Randomised Trial. The LEDA (renaL disEase Progression by Aspirin in Diabetic pAtients) Study. |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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418 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02895113 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Francesco Violi, MD |
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Address:
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Telephone:
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+390649970893 |
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Email:
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francesco.violi@uniroma1.it |
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Affiliation:
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Name:
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Francesco Violi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sapienza University of Rome |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of type 2 diabetes: random blood glucose = 200 mg / dl, fasting blood
glucose = 126 mg/dl, blood glucose 2 hours after oral glucose tolerance test (75 g)
=200 mg/dl, treatment with glucose-lowering agents.
Exclusion Criteria:
1. History of cardiovascular or cerebrovascular events;
2. Presence of inadequate glycaemic control (glycosylated haemoglobin =8%);
3. Clinical diagnosis of type 1 diabetes (diagnosis of diabetes and insulin use before
35 years of age);
4. Patients with renal impairment in G4 stage (eGFR <30 ml/min) at baseline;
5. Chronic active infection or evidence of malignancy in the last 5 years;
6. Autoimmune systemic disease;
7. Cardiac arrhythmia;
8. Use of non-steroidal anti-inflammatory drugs, vitamin supplements, or other
antiplatelet agents in the previous 30 days;
9. Liver Failure (eg cirrhosis);
10. Use of anticoagulants;
11. Life expectancy <1 year;
12. Known allergy to aspirin.
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Intervention(s)
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Drug: Aspirin
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Other: Placebo
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Primary Outcome(s)
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Changes in renal function in diabetic patients treated with aspirin
[Time Frame: 1 year]
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Secondary Outcome(s)
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Relationship between changes of Thromboxane B2 excretion and renal function in diabetic patients treated with aspirin
[Time Frame: 1 year]
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Secondary ID(s)
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LEDA study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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