ISRCTN83474650
Completed
Not Applicable
Development and validation of a risk scoring model to predict net adverse cardiovascular outcomes after primary percutaneous coronary intervention (PCI) in patients pretreated with 600 mg clopidogrel, rationale and design of the RISK-PCI study
Clinical Center of Serbia (Serbia)0 sites1,750 target enrollmentSeptember 30, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Clinical Center of Serbia (Serbia)
- Enrollment
- 1750
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both males and females, 18 years of age or older
- •2\. Chest discomfort persisting for more than 20 minutes
- •3\. Presentation within 12 hours after the onset of symptoms
- •4\. ST elevation in two contiguous leads of at least 0\.2 mV in leads V2?V3 and/or of at least \>0\.1 mV in other leads, or new bundle branch block
- •5\. Cardiac troponin exceeding upper reference limit at admission and/or 24 hours later
Exclusion Criteria
- •1\. Refusal to give consent for invasive treatment
- •2\. Contraindications for dual antiplatelet therapy or contrast agents (active or recent internal bleeding, history of bleeding after non\-steroid anti\-inflammatory agents, known bleeding diathesis, allergy, intracerebral mass or aneurysm, platelet count of \<100,000/mm^3
- •3\. Cardiogenic shock at admission
- •4\. Noncardiac conditions that could limit life expectancy to less than 1 year or that might interfere with compliance with the protocol (active cancer, significant liver or renal disease \[creatinine clearance \<30 ml/min], significant psychiatric disorders)
- •5\. Planned elective surgery necessitating interruption of treatment with thienopyridines during the first 6 months after enrolment
Outcomes
Primary Outcomes
Not specified
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