Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable CAD Treated With Ticagrelor Monotherapy
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was a feasibility trial that was designed to provide preliminary observations and
      generate hypotheses for future studies. The aim of the study is to estimate the difference of
      arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and
      aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary
      artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet
      aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of
      aspirin/ticagrelor dual-therapy.
    

Detailed description: 
      This is a randomized, open labeled, active-controlled pilot study to estimate the difference
      of arachidonic acid induced platelet aggregation rate between ticagrelor monotherapy and
      aspirin/ticagrelor dual-therapy in patients with stable coronary heart disease. The
      anticipated duration of the study is approximately 9 months, including an anticipated
      enrolment period of 8 months and follow-up period of 4weeks.

      Patients with documented coronary heart disease and currently receiving dual-antiplatelet
      therapy with standard dose aspirin and clopidogrel will be enrolled from the study site. For
      patients post acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), they
      must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study.

      The study plan, including enrolment/randomization and follow-up visits, is outlined in Table
      1. Eligible patients will enter a washout phase with ticagrelor for 2 weeks. Then they will
      be randomized to take either ticagrelor alone or aspirin/ticagrelor for 14 days. The efficacy
      evaluation will be done at 7 and 14days after randomization. The primary efficacy parameter
      is the rate of arachidonic acid induced platelet aggregation after 14 days of treatment. All
      patients will be treated to standards of care for coronary heart disease secondary
      prevention.

      Visit 0 (Screening and Enrollment, 0 day) All potentially eligible patients will undergo a
      screening visit following their signed informed consent.

      Following an 8-hour fast, the patients will have screening evaluations performed. Demography,
      medical history, and concomitant medication will be recorded. A physical examination and
      vital signs(pulse and BP), height and weight, as well as blood sampling for laboratory
      assessments of complete blood count (CBC) with differential, serum creatinine, alanine
      aminotransferase (ALT) and aspartate aminotransferase (AST), and AA, adenosine diphosphate
      (ADP) and collagen induced platelet aggregation rate will be done. Standard 12-lead
      electrocardiogram (ECG) readings will be recorded.

      Patients meeting all inclusion criteria and with no exclusion criteria will be enrolled.
      Patients will receive ticagrelor mono-therapy from the evening for 14 days. IP will be
      dispensed.

      Visit 1 (Randomization, 14 days) Suspected adverse events (AEs) will be recorded. A physical
      examination and vital signs (pulse and BP), as well as blood sampling for laboratory
      assessments of AA, ADP and collagen induced platelet aggregation rate and serum thromboxane
      B2 concentration will be done.

      Patients should be told to take ticagrelor in the morning of Visit 1. Patients will be
      randomized in a 1:1 ratio to receive either ticagrelor mono-therapy or aspirin/ticagrelor
      dual-therapy. Investigational product (IP) will be returned and compliance assessed and new
      bottles of IP will be dispensed according to randomized groups.

      Visit 2 (21 days) Suspected AEs will be recorded. Vital signs (pulse and BP) as well as blood
      sampling for laboratory assessments of AA, ADP and collagen induced platelet aggregation rate
      will be done.

      Visit 3 (End of treatment, 28 days) Suspected AEs will be recorded. Vital signs (pulse and
      BP) as well as blood sampling for laboratory assessments of CBC with differential, Scr, ALT
      and AST, AA, ADP and collagen induced platelet aggregation rate will be done. IP will be
      returned and compliance assessed. Instructions for medication after study will be given to
      patients at this time.

      For patients who prematurely discontinued the randomized treatment, a complete end of
      treatment visit will be preferred.
    

Intervention name(s): ticagrelor; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): 90 mg bid for 2 weeks; 100mg Qd for 2 weeks.
Other intervention name(s): Brilinta
Intervention MeSH terms: Aspirin; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ticagrelor; platelet aggregation rate; ADP antagonist; antiplatelet therapy