EUCTR2017-001582-25-FIActive, not recruitingPhase 1
A 12-week, randomized, single-blind, placebo-controlled, multi-centre, parallel group, phase IIa study to evaluate efficacy, safety and tolerability of oral AZD5718 after 4- and 12-weeks of treatment in patients with coronary artery disease (CAD) - FLAVOUR
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •For inclusion in the study patients should fulfil the following criteria:
- •1.Males and females:
- •a.Males must be surgically sterile or using an acceptable method of contraception
- •b.Females must be of non-childbearing potential confirmed at screening by fulfilling one of the following criteria a) postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the postmenopausal range, b) documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- •2.Age =18 to =75
- •3.BMI =18 to =35 kg/m2
- •4.CAD patients, here defined as:
- •a.ACS 7-28 days prior to study randomization (ACS defined as STEMI, non STEMI event documented by ECG, cardiac enzymes [troponin] and angiogram)
- •b.Possible post procedure LAD stenosis is <50% and TIMI flow is = 2
- •5.Provision of signed and dated, written informed consent prior to any study specific procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 133
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 67
Exclusion Criteria
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •1Alanine aminotransferase (ALT) >2 x ULN (i.e., above the normal range) at visit 2, cirrhosis, recent hepatitis, or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C
- •2Uncontrolled 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
- •3Patients 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 AV blockage degree 2-3
- •4Patients with pacemaker
- •5Prior coronary artery by-pass graft (CABG) to LAD
- •6Left ventricle ejection fraction < 30%
- •7Unacceptable level of angina despite maximal medical therapy or unstable angina at entry Canadian Cardiovascular Society (CCS) = 3 (Visit 1 or Visit 2)
- •8Stroke within the previous 6 months from ACS or ongoing treatment with Persantin or Asasantin
- •9Planned treatment with zileuton, leukotriene receptor antagonists (e.g. montelukast), coumadin or steroids during trial
- •10Planned statin therapy dose regimen changes during trial
- •11Chronic use of anticoagulants on therapeutic dose (not including thrombosis prophylaxis) during the study
- •12Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months
- •13NYHA class III-IV heart failure at discharge or hospitalization for exacerbation of chronic heart failure within the previous 3 months from ACS
- •14Previously known severe renal disease (CKD stage 4 or 5) or previously known creatinine clearance calculated by Cockcroft Gault equation <30 ml/min*m2
- •15Aortic or mitral valvular disease or valvular disease classified as severe
- •16Known allergy to adenosine
- •17Known elevated intracranial pressure
- •18Heart rate < 40 bpm
- •19Systolic blood pressure < 90 mmHg
- •20Asthma or COPD with strong reactive component in judgment of investigator
- •21Treatment with dipyridamole, theophyllamine, fluvoxamine, rifampicin, fenytoin or carbamazepine
- •22Inability to comply with the study protocol
- •23History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class as study drugs
- •24Patients unable to give their consent or communicate reliably with the investigator or vulnerable patients e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order
- •25Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •26Participation in another clinical study with an investigational product during the last 3 months
- •27Previous randomization in the present study
- •28Known history or current abuse of drugs or alcohol
Investigators
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