Status:
COMPLETED
AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
Lead Sponsor:
AstraZeneca
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 13...
Detailed Description
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 (Denmark, Finland...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2020
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03317002
Start Date
October 30 2017
End Date
April 8 2020
Last Update
June 30 2021
Active Locations (9)
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1
Research Site
Aarhus, Denmark, 8200
2
Research Site
Frederiksberg, Denmark, 2000
3
Research Site
Odense C, Denmark, 5000
4
Research Site
Kuopio, Finland, 70210