Targeting Platelet-Leukocyte Aggregates in Pneumonia With Ticagrelor

Completed · Phase 1 · Has a placebo group

Conditions studied: Pneumonia, Community Acquired Pneumonia, Hospital Acquired Pneumonia, Acute Lung Injury

In brief

The hypothesis to be tested is that ticagrelor (Brilinta™) will reduce platelet activation and markers of inflammation in patients with pneumonia.

Key facts

Study ID

NCT01883869

Run by

University of Kentucky

People needed

60

Starts

2013-06-01

Expected to finish

2016-06-01

Last updated by the study team

2018-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be 18 years of age or older
• Subjects must diagnosed with Community acquired pneumonia (CAP) or hospital acquired pneumonia (HAP) within 48 hours of diagnosis or presentation to hospital.
• Pneumonia will be defined as patients with a new radiographic finding(s) consistent with pneumonia and at least two of the following signs.
• Cough
• Fever: axillary temperature >37.5ºC or tympanic temperature >38.5ºC
• Hypothermia: axillary temperature <34ºC or tympanic temperature <35ºC.
• Purulent sputum production or respiratory secretion.
• Total peripheral white blood cell (WBC) count >10,000/mm3; or >15% band forms, regardless of total peripheral white count; or leucopenia with total WBC < 4500/mm
• Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
• Hypoxemia - defined as partial O2 pressure <60mmHg while the patient was breathing normal air or a decrease in the partial O2 pressure of >= 25% from an initial range.

You may not qualify if…

• Contraindication to ticagrelor (hypersensitivity or reaction to ticagrelor or another P2Y12 antagonist)
• Active bleeding or major bleeding history (e.g. intracranial bleeding)
• Clinically important anemia or thrombocytopenia (platelet count <30)
• Surgery within 30 days or anticipated major surgery (Thoracic, Abdominal, Brain; placement of lines, tracheostomy, and chest tubes are not considered major).
• Oral anticoagulant therapy that cannot be stopped.
• Inability or unwillingness of treating physician to reduce dose of aspirin to 81mg.
• Fibrinolytic therapy in the last 24 hours.
• Increased risk of bradycardic events - 2nd or 3rd degree heart block, bradycardia induced syncope - unless pacemaker in place.
• Underlying immunodeficiency (HIV, neutropenia, receiving immunomodulating agents, active hematologic malignancy, functional or anatomical asplenia and hypogammaglobulinemia).
• Moderate or severe liver disease defined by Child Pugh score >7 using data from outpatient setting or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 fold upper limits of normal.
• Renal dialysis
• Concomitant therapy with strong CYP3A inhibitors; ketoconazole, itraconazole, voriconazole, saquinavir, nelfinavir, indinavir, or atazanavir.
• Concomitant therapy with CYP3A substate with narrow therapeutic window: cyclosporin, quinidine.
• Concomitant therapy with CYP3A inducer; rifampin/rifampicin, phenytoin, carbamazepine.
• Pregnancy or lactation
• Active treatment for cancer.

Where it is running

• University of Kentucky Hospitals — Lexington, Kentucky, United States
• University of Kentucky Hospital — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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