Status:
COMPLETED
AZD8601 Study in CABG Patients
Lead Sponsor:
AstraZeneca
Conditions:
Heart Failure
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled, sequential design, multicentre study in patients with moderately impaired systolic function undergoing CABG surgery. Twenty four (24) patients s...
Eligibility Criteria
Inclusion
- For inclusion in the study patients should fulfil the following criteria at Visit 1 and/or 2:
- 1\. Provision of signed and dated informed consent prior to any study specific procedures
- Males and females:
- Males must be surgically sterile or using an acceptable method of contraception
- 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 3. Age \>18 years 4. Indication for elective CABG surgery enrolled at least 15 days before the planned surgery 5. Moderately reduced global LVEF at rest (30% ≤ LVEF ≤ 50%) from medical records 6. If patient is on statin, ACE inhibitor/ARB, and/or beta-blocker, the dose should be stable at least 2 weeks prior to Visit 1 7. Patients who are blood donors should not donate blood during the study and for 3 months following their last dose of AZD8601.
Exclusion
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- 1\. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Previous randomisation in the present study 3. Participation in another clinical study with an investigational product during the last 3 months 4. BMI \> 35 kg/m2 OR poor image window for echocardiography 5. Need for CABG emergency operation. (Emergency operation is defined as significant symptom status worsening in CAD, such as crescendo angina, unstable angina or ACS requiring rescheduling the revascularization. CAD should be stable at least 3 months prior to Visit 3.) 6. History of ventricular arrhythmia (≥ Lown III) without Implantable Cardiac Defibrillator (ICD) History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study 8. Severe co-morbidities that can interfere with the execution of the study, interpretation of study results or affect the safety of the patient, in judgement of the investigator 9. eGFR ≤ 30 mL/min (derived from creatinine clearance, calculated by local lab) 10. For CFVR (Visit 1) and sMBF (Visit 2) measurement:
- Known severe adverse reactions to adenosine
- Known elevated intracranial pressure
- AV block ≥ second degree and/or sick sinus syndrome in patient without pacemaker
- Heart rate \< 40 bpm (ECG verified)
- Systolic blood pressure \< 90 mmHg
- Asthma or COPD with strong reactive component in judgement of investigator
- Treatment with dipyridamole (e.g. Persantin or Asasantin), theophyllamine or fluvoxamine that cannot be paused 11. Inability to comply with the protocol 12. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class as study drugs 13. Patients 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 14. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody or human immunodeficiency virus, at Visit 1 15. Known history of drug or alcohol abuse 16. Any concomitant medications that are known to be associated with Torsades de Pointes 17. History of QT prolongation associated with other medications that required discontinuation of that medication 18. Congenital long QT syndrome 19. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3).
- 20\. Current atrial fibrillation as well as paroxysmal atrial fibrillation.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03370887
Start Date
February 5 2018
End Date
June 30 2021
Last Update
October 10 2024
Active Locations (10)
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1
Research Site
New Haven, Connecticut, United States, 06510
2
Research Site
Kuopio, Finland, 70210
3
Research Site
Tampere, Finland, 33520
4
Research Site
Turku, Finland, 20520