Phase 2
Completed N=129
AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
Source: ClinicalTrials.gov NCT03317002 ↗Enrolled (actual)
129
Serious AEs
8.6%
Results posted
Jun 2021
Primary outcomePrimary: Change From Baseline in Creatinine-normalized u-LTE4 at Week 4 — 0.04; 0.09; 1.09 Ratio — p=<0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Creatinine-normalized u-LTE4 at Week 4 |
0.04; 0.09; 1.09 | <0.001 sig |
| SECONDARY Change From Baseline in Creatinine-normalized u-LTE4 at Week 12 |
0.04; 0.09; 1.09 | <0.001 sig |
| SECONDARY Change From Baseline in CFVR at Week 12 |
0.93; 0.98; 1.16 | — |
| SECONDARY Change From Baseline in CFVR at Week 4 |
1.03; 1.15; 1.08 | — |
| SECONDARY Summary of Plasma Concentrations of AZD5718 |
611.88; 47.88; 59.36; 16.57; 48.00; 11.01 | — |
| SECONDARY Change From Baseline in LAD Hypereamic Flow at 4 Weeks |
0.02; 0.04; 0.03 | — |
| SECONDARY Change From Baseline in LVEF at 4 Weeks |
-0.23; 2.70; 0.48 | — |
| SECONDARY Change From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 Weeks |
1.02; 0.98; 1.03 | — |
| SECONDARY Change From Baseline in LV-GLS at Rest at Week 4 |
-0.41; 0.34; -0.63 | — |
| SECONDARY Change From Baseline in LV-GCS at Rest at Week 4 |
0.34; 1.71; -1.88 | — |
| SECONDARY Change From Baseline in LAD Resting Mean Diastolic Flow Velocity at 4 Weeks |
1.01; 0.92; 0.99 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03317002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.