Effect of the therapy with Prasugrel or Ticagrelor in diabetic patients with acute cardiovascular diseases.
- Conditions
- Patients with Acute Coronary Syndrome and Diabetes MellitusMedDRA version: 16.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-001794-24-IT
- Lead Sponsor
- AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
All consecutive pazients coming with acute coronary syndrome and diabetes mellitus
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21
Exclusion Criteria
Patients without acute coronary syndrome or without diabetes mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: We sought to investigate the non-inferiority antiplatelet effect in terms of level platelet reactivity (< 240 PRU) of loading dose of prasugrel (60 mg) versus loading dose of Ticagrelor (180 mg) in patients undergoing PPCI at 6 hours from the administration of the drug (primary end-point).;Secondary Objective: Secondary end-points will be in hospital NACE (cardiovascular death, myocardial infarction, stroke and bleedings according to the TIMI criteria), stent thrombosis in overall population.;Primary end point(s): We sought to investigate the non-inferiority antiplatelet effect in terms of level platelet reactivity (< 240 PRU) of loading dose of prasugrel (60 mg) versus loading dose of Ticagrelor (180 mg) in patients undergoing PPCI at 6 hours from the administration of the drug (primary end-point).;Timepoint(s) of evaluation of this end point: Blood samples will be performed at 2, 6 and 12 hours for the evaluation of the points
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary end-points will be in hospital NACE (cardiovascular death, myocardial infarction, stroke and bleedings according to the TIMI criteria), stent thrombosis in overall population.;Timepoint(s) of evaluation of this end point: Direct visits or telephone interview will be performed at 1, 6 and 12 months