Risk model to predict adverse outcomes after primary percutaneous coronary intervention (PCI)
| ISRCTN | ISRCTN83474650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83474650 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/09/2008
- Registration date
- 30/09/2008
- Last edited
- 28/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Igor Mrdovic
Scientific
Scientific
Klinicki Centar Srbije
Institut za Kardiovaskularne Bolesti
Urgentni Centar - Kardiologija
Pasterova 2
Belgrade
11000
Serbia
| Phone | +381 63 462 488 |
|---|---|
| mediacentar@klinicki-centar.co.yu |
Study information
| Study design | Observational, longitudinal, cohort, single-centre trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | RISK-PCI |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2006 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,750 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- Serbia
Study participating centre
Klinicki Centar Srbije
Belgrade
11000
Serbia
11000
Serbia
Sponsor information
Clinical Center of Serbia (Serbia)
Hospital/treatment centre
Hospital/treatment centre
Institut za Kardiovaskularne bolesti (KCS)
Pasterova 2
Belgrade
11000
Serbia
| Phone | +381 113 618 444 |
|---|---|
| mediacentar@clinicki-centar.co.yu | |
| Website | http://www.icvd-kcs.org |
Funders
Funder type
Hospital/treatment centre
Clinical Center of Serbia, Institute for Cardiovascular Diseases, Cardiology Clinic (Serbia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | incidence, predictors, and 30-day outcomes | 01/01/2012 | Yes | No | |
| Results article | results | 20/01/2013 | Yes | No |
