Impact of Ticagrelor Re-load on Pharmacodynamic Profiles
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Platelets are parts of your blood that stick together to help form a clot. The stickier your
      platelets are, the greater your chance of having a heart attack. A clot in the wrong place
      can lead to a heart attack or stroke. Ticagrelor (Brilinta) keeps platelets from sticking
      together and it helps people from having a heart attack. The American College of Cardiology
      has recommended a combination of aspirin and Brilinta as one of the best treatments for the
      prevention of heart attacks, and death in patients who have had a heart attack or coronary
      stents. However, it is unknown if Brilinta may improve its work to keep platelets from
      sticking together giving a loading dose in patients already treated with Brilinta. A loading
      dose is a one-time increased dose of the same drug. The purpose of this study is to
      demonstrate whether the platelets of patients treated with Brilinta become less sticky when
      Brilinta is re-loaded.
    

Detailed description: 
      A higher degree of platelet inhibition remains the goal of peri-interventional and long-term
      anti-thrombotic therapy in patients with coronary artery disease. Previous observations have
      shown that in patients on clopidogrel therapy undergoing percutanoues coronary intervention
      who get re-loaded with clopidogrel obtain enhanced platelet inhibition. Ticagrelor represents
      a new class of nonthienopyridine platelet inhibitors designed to address the limitations of
      current oral antiplatelet therapy, which has been recently approved for clinical use.
      However, to date it is unknown if greater inhibition of platelet aggregation can be achieved
      by adding a ticagrelor loading dose in patients already on maintenance ticagrelor therapy (90
      mg twice daily). In addition, how to manage patients undergoing coronary interventions
      already on chronic ticagrelor therapy with regards to ticagrelor loading is an emerging
      clinical question which has yet to be explored. Therefore, understanding the pharmacodynamic
      implications of a ticagrelor re-load strategy in patients on already on chronic ticagrelor
      therapy is warranted. The scope of the present study is to evaluate the impact of ticagrelor
      re-load in patients on chronic ticagrelor therapy. A total of 60 patients will be randomized
      into one of the following two arms of treatment: 1) 90 mg of ticagrelor; 2) 180 mg of
      ticagrelor. Pharmacodynamic assessments will be performed at baseline, 1-hour and 4-hour
      after dosing administration. Comparison between baseline and 4-hour values in term of
      platelet P2Y12 reactivity index determined by whole blood vasodilator-stimulated
      phosphoprotein will be the primary end-point of the study. Secondary endpoints will include
      other pharmacodynamic measures.
    

Intervention name(s): Ticagrelor 180mg; Ticagrelor 90mg
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 180 mg of ticagrelor; Patients will receive 90 mg of ticagrelor
Other intervention name(s): Brilinta; Brilinta
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: coronary disease, platelet function, platelet inhibitors