Evaluation of platelet functional response in patients with acute coronary syndromes without ST-segment elevation (NSTEACS)treated with clopidogrel.

• Conditions: Patients with acute coronary syndromes without ST-segment elevation (NSTEACS).; MedDRA version: 15.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-003125-24-IT
• Lead Sponsor: A.O. UNIVERSITARIA INTEGRATA DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-21
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified