AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: AZD5718; AZD5718; Placebo
Intervention description: Oral dose of AZD5718 (tablet); Oral dose of AZD5718 (tablet); Matching placebo (tablet)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomized, single-blind, placebo-controlled, parallel-group, multicentre study in
      patients with CAD. The study will be conducted at approximately 10 centres in 3 countries.
      Approximately 138 CAD patients will be randomized to AZD5718 or placebo (treatment duration
      12 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females of non-childbearing potential

          -  Age ≥18 to ≤75

          -  Body Mass Index (BMI) ≥18 to ≤35 kg/m2

          -  CAD patients, here defined as:

        ACS 7-28 days prior to study randomization (ACS defined as STEMI, non STEMI event
        documented by Electrocardiogram (ECG), cardiac enzymes [troponin] and angiogram) Provision
        of signed and dated, written informed consent prior to any study specific procedures

        Exclusion Criteria:

          -  Uncontrolled Type 1 or Type 2 diabetes defined as haemoglobin A1c (HbA1c) Diabetes

          -  Control and Complications Trial (DCCT)> 9% or International Federation of Clinical
             Chemistry (IFCC) >74.9 mmol/mol

          -  Patients with atrial fibrillation (chronic or current) or history of ventricular
             tachycardia requiring therapy for termination, or symptomatic sustained ventricular
             tachycardia or sick sinus syndrome or Atrioventricular blockage degree 2-3

          -  Prior coronary artery by-pass graft (Coronary artery bypass grafting) to Left Anterior
             Descending artery (LAD)

          -  Left ventricle ejection fraction < 30%

          -  Unacceptable level of angina despite maximal medical therapy or unstable angina at
             entry

          -  Canadian Cardiovascular Society (CCS) ≥ 3 (Visit 1 or Visit 2)

          -  Stroke within the previous 6 months from ACS or ongoing treatment with Persantin or
             Asasantin

          -  Chronic use of anticoagulants on therapeutic dose (not including thrombosis
             prophylaxis) during the study

          -  Planned additional cardiac intervention (e.g., Percutaneous coronary intervention
             (PCI), Coronary artery bypass grafting (CABG) within next 6 months

          -  New York Heart Association (NYHA) class III-IV heart failure or decompensated heart
             failure at discharge or hospitalization for exacerbation of chronic heart failure
             within the previous 3 months from ACS

          -  Previously known severe renal disease (Chronic Kidney Disease (CKD) stage 4 or 5) or
             previously known creatinine clearance calculated by Cockcroft Gault equation <30
             ml/min*m2

          -  Known allergy to adenosine and mannitol, or experience of previous adverse effects of
             adenosine stress testing.

          -  Participation in another interventional clinical study with an investigational
             pharmaceutical product during the last 3 months also including drug eluting stents.