EUCTR2012-003125-24-IT
Active, not recruiting
Not Applicable
Evaluation of platelet functional response in relation to the bioavailability of clopidogrel in patients with acute coronary syndromes without ST-segment elevation (NSTEACS).
A.O. UNIVERSITARIA INTEGRATA DI VERONA0 sitesSeptember 21, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- A.O. UNIVERSITARIA INTEGRATA DI VERONA
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects (aged 18 to 75 years) with non–ST\-segment elevation ACS (NSTEACS) and GRACE risk score\< 140\. Patients included must have platelet count \=450\.000/mm3 at presentation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 15
Exclusion Criteria
- •\-Cardiogenic shock at recruitment; \- Refractory ventricular arhythmias;\- Prior Transient Ischemic Attack or Stroke; \-Active internal bleeding or history of bleeding diathesis;\-Increased bleeding risk for:Propensity to bleed (e.g., recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, active peptic ulcer disease, or severe hepatic impairment); arteriovenous malformation, or aneurysm;concomitant use of medications that increase the risk of bleeding as warfarin and fibrinolytic therapy; chronic use of non\-steroidal anti\-inflammatory drugs \[NSAIDS] different from aspirin; CABG; platelet count \<100\.000/mm3 at presentation; anemia (hemoglobin \<10 g/dL) at presentation. \- Treatment with clopidogrel during the previous 30 days; \-BMI \> o \= 33; \-Intolerance or allergy to aspirin or clopidogrel;\-Severe illness with life expectancy less than 1 year;\-Test positive for pregnancy (based on a urine or serum pregnancy test) at presentation;\-Women who have given birth within the previous 90 d;\-Any condition associated with poor treatment compliance, including alcoholism, mental illness (or \-Treatment with psychotropic drugs), or drug dependence.\- Women of childbearing age not using contraception;\- Women during lactation;\- Patients in emergency situations;\- Subjects incapable of giving legal consent.
Outcomes
Primary Outcomes
Not specified
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