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Post-treatment PLATelet aggregation-guided therapy FOR ST-segment elevation Myocardial infarction
DOI 10.1186/ISRCTN83081599
ClinicalTrials.gov identifier
EudraCT number
Public title Post-treatment PLATelet aggregation-guided therapy FOR ST-segment elevation Myocardial infarction
Scientific title Post-treatment PLATelet aggregation-guided therapy FOR ST-segment elevation Myocardial infarction: a randomized trial
Serial number at source 553/12
Study hypothesis Antiplatelet regimen tailoring is superior to standard antiplatelet regimen in intermediate to high-risk ST-segment elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PCI), with regard to the primary end point.
Lay summary Lay summary under review 2
Ethics approval Ethics Committee, Clinical Center of Serbia, 02/06/2009, ref: 553/12
Study design Prospective open-label observer-blinded randomized parallel-group actively controlled single-center clinical trial
Countries of recruitment Serbia
Disease/condition/study domain Acute myocardial infaction with ST elevation
Participants - inclusion criteria 1. Patients with intermediate to high risk for 30-day Major Adverse Cardiac Events (MACE) (RISK-PCI score >3) undergoing primary PCI with stent implantation within 12 hours of the onset of symptoms
2. Ability to comply with study protocol
3. Negative test for pregnancy for women of childbearing potential before enrollment and agreement to use a reliable method of birth control during the study
Participants - exclusion criteria Pre-procedural:
1. Any history of hemorrhagic stroke
2. Ischemic stroke within 30 days of randomization
3. Evidence of active abnormal bleeding within 3 months of randomization
4. High risk for bleeding on long-term clopidogrel therapy
5. Current therapy with coumadin anticoagulation
6. Pregnancy or nursing
7. Current enrollment in another investigational drug or device study

1. Balloon angioplasty without stent placement
2. Unsuccessful pPCI (post-procedural TIMI flow 0)

1. Died within 24 hours after loading dose
2. Active internal bleeding
3. Hemoglobin < 10 g/dL or drop in hemoglobin by ≥3 g/dL
4. Platelet count < 100 000 x 10-9/L.
5. Thrombin Receptor Activating Peptide (TRAP) value <500 AU
6. Indication for permanent anticoagulant therapy
Anticipated start date 01/06/2012
Anticipated end date 01/06/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 632
Interventions Before pPCI, 300 mg aspirin and 600 mg clopidogrel loading doses will be administered. Unfractionated heparin is started as 100 IU/kg bolus (60 IU/kg if glycoprotein (GP) IIb/IIIa receptor inhibitor was used); the 12 IU/kg/h infusion followed if clinically indicated (atrial fibrillation, left ventricular (LV) thrombus or aneurysm, recent or recurrent venous thromboembolism, deferred sheath removal). Proton-pump inhibitor pantoprazole or H2-blocker ranitidine will be given to selected patients at risk for gastrointestinal hemorrhage. GP IIb/IIIa receptor inhibitor tirofiban will be administered during the procedure at the discretion of the operator.

Patients will be randomly allocated to ART (interventional arm) or standard treatment (control arm) using a computer-generated 1:1 simple randomization scheme. Post-treatment platelet aggregation (PPA) will be assessed in patients enrolled in the intervention arm of the trial. Patients enrolled in the control arm will receive standard antiplatelet regimen including 100 mg aspirin and 75 mg clopidogrel without assessment of PPA. The treating physicians will not be blinded to the intervention since an open design will make it possible for investigators to perform necessary adjustments of the antiplatelet regimen in accordance with PPA status. To minimize any possible bias inherent in the open design, endpoints will be evaluated by a blinded endpoint committee (Probe design). This will limit investigator bias and allow for a valid analysis despite the open design.

ASPI and ADP tests will be used to analyze the effect of aspirin, clopidogrel and ticagrelor on PPA in the interventional arm. PPA above 50%, compared to the basal value estimated by thrombin-receptor agonist peptide (TRAP) test, will be linked with low responsiveness. Low responders to aspirin will receive 200 mg aspirin daily for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor daily for 1 year.
Primary outcome measure(s) The time to the first of composite events including death, nonfatal infarction, stroke or definite subacute stent thrombosis. Major safety end points includeTIMI major bleeding unrelated to coronary artery bypass graft surgery. Patients will be followed-up after discharge from hospital at 30 days and 1 year after enrolment.
Secondary outcome measure(s) 1. Individual components of MACE
2. Total bleeding and the need for blood transfusions

Patients will be followed-up after discharge from hospital at 30 days and 1 year after enrolment.
Sources of funding Clinical Center of Serbia (Serbia)
Trial website
Publications 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23373620
Contact name Prof  Igor  Mrdovic
  Address Clinical Center of Serbia
Pasterova 2
  City/town Belgrade
  Zip/Postcode 11000
  Country Serbia
  Tel +38 11 1366 2364
  Fax +38 11 1366 2364
  Email igormrd@gmail.com
Sponsor Clinical Center of Serbia (Serbia)
  Address Pasterova 2
  City/town Belgrade
  Zip/Postcode 11000
  Country Serbia
  Tel +38 11 1361 7777
  Fax +38 11 1264 6988
  Email mediacentar@klinicki-centar.co.rs
  Sponsor website: http://www.ksc.ac.rs
Date applied 23/03/2012
Last edited 30/05/2014
Date ISRCTN assigned 22/05/2012
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