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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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12 December 2020 |
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Main ID: |
NCT02377388 |
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Date of registration:
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05/01/2015 |
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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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DPP-4 Inhibitors and Acute Myocardial Infarction:Effects on Platelet Function
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Scientific title:
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DPP-4 Inhibitors in Patients With Type 2 Diabetes and Acute Myocardial Infarction:Effects on Platelet Function |
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Date of first enrolment:
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February 7, 2017 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02377388 |
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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. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Jose C Nicolau, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heart Institute(InCor)-University of São Paulo GH-Medical School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- previous diagnosis of type 2 diabetes mellitus,with treatment including insulin and/or
oral antidiabetic agent;
- subjects without previous diagnosis of diabetes,but HbA1c admission >= 6,5% during
current hospital-stay
- AMI with or without ST-elevation;
- use of double antiplatelet therapy;
- signed informed consent term
Exclusion Criteria:
- GFR <30 ml/min;
- use of DPP4 inhibitors or glucagon- like peptide-1(GLP1) analogue in the past 6
months;
- use of strong inhibitors of cytochrome P450(CYP3A4/5) ou glucocorticoids;
- severe systemic decompensation requiring insulin infusion;
- Killip classification of myocardial infarction grade >2;
- previous history of pancreatitis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Platelet Aggregation During Acute Myocardial Infarction
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Intervention(s)
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Drug: sitagliptin OR saxagliptin
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Drug: placebo
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Primary Outcome(s)
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changes on platelet aggregability.
[Time Frame: baseline and 4(+-2) days after drug exposure.]
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Secondary Outcome(s)
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platelet aggregability differences by two point-of-care methods.
[Time Frame: baseline and 30(+-5) days after drug exposure.]
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platelet aggregability differences by two point-of-care methods.
[Time Frame: baseline and 4 (+-2) days after drug exposure.]
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changes on platelet aggregability.
[Time Frame: baseline and 30(+-5) days after drug exposure.]
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Secondary ID(s)
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University of São Paulo GH
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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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