Contact information
Type
Scientific
Primary contact
Prof Igor Mrdovic
ORCID ID
Contact details
Klinicki Centar Srbije
Institut za Kardiovaskularne Bolesti
Urgentni Centar - Kardiologija
Pasterova 2
Belgrade
11000
Serbia
+381 63 462 488
mediacentar@klinicki-centar.co.yu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
RISK-PCI
Study hypothesis
The primary hypothesis of the trial is that an accurate prediction of net adverse cardiovascular outcomes (NACE) at presentation may result in a significant reduction of NACE after primary percutaneous coronary intervention (pPCI).
Ethics approval
The study was approved by a Local Research Ethics Committee of the School of Medicine, University of Belgrade on the 21st February 2008 (ref: No 470/II-4).
Study design
Observational, longitudinal, cohort, single-centre trial
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute ST elevation myocardial infarction
Intervention
Recruitment for this study began on the 1st February 2006. The completion of enrolment is expected in summer 2009.
The first 1,166 consecutive patients will enter the study set, while the further 584 patients will enter the validation set. Risk factors and scores derived from the study set will be tested in the validation set. Primary PCI and stenting of the infarction-related artery (IRA) is performed according to standard technique via femoral approach. Flow grades are assessed according to TIMI criteria. Procedural success is defined as Thrombolysis in Myocardial Infarction-3 (TIMI-3) flow and <30% stenosis after intervention. Drug-eluting stents (DES) are encouraged in selected patients with in-stent restenosis, diabetes mellitus, very long or bifurcation lesions.
Before pPCI, 300 mg aspirin and 600 mg clopidogrel are administered to all eligible patients. Unfractionated heparin is started as 60 IU/kg bolus; the 12 U/kg/h infusion follows during the next 24 hours in uncomplicated patients or longer if clinically indicated. The dose is based on the activated Partial Thromboplastin Time (PTT). 40 mg proton-pump inhibitor pantoprazol or 50 mg H2-blocker ranitidine are given intravenously to all patients before pPCI; a peroral treatment follows (40 mg pantoprazol/day or 50 mg ranitidine/day) during the next 2-3 days. Enoxiparin sodium (100 anti-Xa IU/kg every 12 hours) is used subcutaneously in patients under 75 years who failed to reach the therapeutic aPTT with standard heparin treatment, those who did not receive GP IIb/IIIa inhibitor, and those with renal failure (creatinine clearance <60 ml/min). In selected patients with visible intracoronary thrombi, GP IIb/IIIa receptor inhibitor tirofiban - the dose based on body weight (25 µg/kg bolus followed by 18- to 24-hour 0.15 µg/kg/min infusion), adjusted for renal impairment (half of the usual infusion dose if creatinine clearance <60 ml/min) - is administered during the pPCI. Aspirin, clopidogrel, beta-blockers, lipid-lowering agents and ACE inhibitors are used after pPCI, according to current guidelines. Patients who show clinical signs of heart failure are treated with digitalis, diuretics, or inotropic agents at the discretion of investigators. Bleeding patients are treated with blood product transfusion if haemoglobin is <10 g/dL. If necessary, one or both antiplatelet agents will be discontinued.
Temporary pacemaker is placed in all patients with high-grade AV block or bradiarrhythmia and hemodynamic compromise. Intra-aortic balloon pump is used in patients who progress to Killip IV heart failure. If bleeding is life-threatening, surgery may be performed.
Patients are followed-up at 30 days and at 1 year after enrolment, on the intention-to-treat principle. Follow-up data are obtained by telephone interviews.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Risk score for composite major adverse cardiac events (MACE) including death, nonfatal reinfarction, ischaemic stroke and target vessel revascularisation (efficacy endpoint)
2. Risk score for major bleeding (safety endpoint)
Secondary outcome measures
Efficacy:
1. Individual components of MACE
2. Stent thrombosis
Safety:
3. Incidence of bleeding according to the TIMI and GUSTO classification
4. Need for transfusions
5. Withdrawal of dual antiplatelet therapy
Overall trial start date
01/02/2006
Overall trial end date
01/07/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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 V2V3 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1,750
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Serbia
Trial participating centre
Klinicki Centar Srbije
Belgrade
11000
Serbia
Sponsor information
Organisation
Clinical Center of Serbia (Serbia)
Sponsor details
Institut za Kardiovaskularne bolesti (KCS)
Pasterova 2
Belgrade
11000
Serbia
+381 113 618 444
mediacentar@clinicki-centar.co.yu
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Clinical Center of Serbia, Institute for Cardiovascular Diseases, Cardiology Clinic (Serbia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 incidence, predictors, and 30-day outcomes in: http://www.ncbi.nlm.nih.gov/pubmed/22107800
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/21663982
Publication citations
-
Results
Mrdovic I, Savic L, Krljanac G, Asanin M, Perunicic J, Lasica R, Marinkovic J, Kocev N, Vasiljevic Z, Ostojic M, Predicting 30-day major adverse cardiovascular events after primary percutaneous coronary intervention. The RISK-PCI score., Int. J. Cardiol., 2013, 162, 3, 220-227, doi: 10.1016/j.ijcard.2011.05.071.
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Mrdovic I, Savic L, Krljanac G, Perunicic J, Asanin M, Lasica R, Antonijevic N, Kocev N, Marinkovic J, Vasiljevic Z, Ostojic M, Incidence, predictors, and 30-day outcomes of new-onset atrial fibrillation after primary percutaneous coronary intervention: insight into the RISK-PCI trial., Coron. Artery Dis., 2012, 23, 1, 1-8, doi: 10.1097/MCA.0b013e32834df552.