AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).

• Status: Completed
• Trial end date: 2020-04-08
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

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.