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CompletedNCT03370887Updated Oct 10, 2024Results posted

AZD8601 Study in CABG Patients

A Phase 2 interventional study of AZD8601 and Placebo in Heart Failure, sponsored by AstraZeneca. Completed at 10 sites in 5 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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 scheduled for elective bypass surgery will be randomized (up to approximately 33 patients if replacements are needed). The objective is to investigate safety and tolerability of AZD8601 following epicardial injection in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery with moderately impaired systolic function. At Visit 3 patients will receive either AZD8601 or placebo as epicardial injections and will then be followed up at 14 days (telephone visit) and 1, 3 and 6 months (on-site) post-surgery.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 11 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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:

  1. Males must be surgically sterile or using an acceptable method of contraception
  2. 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 criteria

Exclusion Criteria:

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Low dose AZD8601 (3 mg)

    8 patients will be randomised to receive 3 mg AZD8601

    Drug: AZD8601

  • Experimental
    High dose AZD8601 (30 mg)

    8 patients will be randomised to receive 30 mg AZD8601

    Drug: AZD8601

  • Placebo comparator
    Placebo

    8 patients will be randomised to receive placebo injections

    Drug: Placebo

Interventions

  • DrugAZD8601

    AZD8601 solution for injection, 0,5 mg/mL and 5 mg/mL will be given as 30 injections of 0.1 mg (3 mg per patient), or 1 mg (30 mg per patient) respectively on a single occasion

  • DrugPlacebo

    Placebo for AZ8601 injection for solution will be given as 30 injections per patient on a single occasion

06

What researchers measure

Primary outcomes

  1. Number of Subjects With Adverse Events

    Time frame: From baseline to end of follow up at 6 months

  2. Pulse Rate (Vital Sign)

    Time frame: From baseline to end of follow up at 6 months

  3. Number of Subjects With an ECG Determined to be Abnormal and Clinically Significant

    Time frame: From baseline to end of follow up at 6 months

  4. Number of Subjects With High Values of Leukocytes, Particle Concentration

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  5. Oxygen Saturation (Vital Sign)

    Time frame: From baseline to end of follow up at 6 months

  6. Systolic Blood Pressure (Vital Sign)

    Time frame: From baseline to end of follow up at 6 months

  7. Number of Subjects With High Values of Erythrocytes, Particle Concentration

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  8. Diastolic Blood Pressure (Vital Sign)

    Time frame: From baseline to end of follow up at 6 months

  9. Number of Subjects With High Values of Erythrocyte, Volume Fraction

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  10. Number of Subjects With High Values of Erythrocytes, Mean Cell Volume

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  11. Number of Subjects With High Values of Hemoglobin

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  12. Number of Subjects With High Values of Neutrophils

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  13. Number of Subjects With High Values of Lymphocytes

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  14. Number of Subjects With High Values of Monocytes

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  15. Number of Subjects With High Values of Eosinophils

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  16. Number of Subjects With High Values of Basophils

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  17. Number of Subjects With High Values of Platelets

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  18. Number of Subjects With High Values of Reticulocytes

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  19. Number of Subjects With High Values of Prothrombin Complex INR

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  20. Number of Subjects With High Values of Activated Partial Thromboplastin Time

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  21. Number of Subjects With High Values of Fibrinogen

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  22. Number of Subjects With High Values of Sodium

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  23. Number of Subjects With High Values of Potassium

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  24. Number of Subjects With High Values of Urea

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  25. Number of Subjects With High Values of Creatinine

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  26. Number of Subjects With High Values of Albumin

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  27. Number of Subjects With High Values of Calcium

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  28. Number of Subjects With High Values of Phosphate

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  29. Number of Subjects With High Values of Alkaline Phosphatase

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  30. Number of Subjects With High Values of Alanine Aminotransferase

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  31. Number of Subjects With High Values of Aspartate Aminotransferase

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

  32. Number of Subjects With High Values of Bilirubin, Total

    Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

    Time frame: From baseline to end of follow up at 6 months

07

Results

Posted Oct 10, 2024

Participant flow

This study was conducted at 4 clinical research centers in Finland and Germany First subject enrolled (First subject first visit/first consent signed date): 2018. Last subject last visit: 2021.

Participant flow — Overall Study
MilestoneAZD8601 3mgPlacebo
Started74
Completed74
Not completed00

Outcome measures

PrimaryNumber of Subjects With Adverse Events
Time frame:
From baseline to end of follow up at 6 months
Reported as:
Count of participants · Participants
Number of Subjects With Adverse Events
ParticipantsAZD8601 3 mgPlacebo
Number of Subjects With Adverse Events74
PrimaryPulse Rate (Vital Sign)
Time frame:
From baseline to end of follow up at 6 months
Reported as:
Mean · beats/min
Pulse Rate (Vital Sign)
beats/minAZD8601 3 mgPlacebo
Baseline63.1 ± 10.4262.6 ± 6.04
Day 181.3 ± 7.3875.2 ± 4.20
Day 285.2 ± 5.5481.1 ± 7.01
Day 383.6 ± 8.3882.4 ± 6.80
Day 481.9 ± 14.5475.3 ± 7.63
Visit 5 (Day 30)74.3 ± 13.3365.5 ± 6.81
Visit 6 (Day 91)66.9 ± 15.0570.8 ± 7.18
Visit 7 (Day 182)63.6 ± 15.6261.0 ± 2.16
PrimaryNumber of Subjects With an ECG Determined to be Abnormal and Clinically Significant
Time frame:
From baseline to end of follow up at 6 months
Reported as:
Count of participants · Participants
Number of Subjects With an ECG Determined to be Abnormal and Clinically Significant
ParticipantsAZD8601 3 mgPlacebo
Baseline00
End of treatment10
PrimaryNumber of Subjects With High Values of Leukocytes, Particle Concentration

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Leukocytes, Particle Concentration
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment31
PrimaryOxygen Saturation (Vital Sign)
Time frame:
From baseline to end of follow up at 6 months
Reported as:
Mean · Percent
Oxygen Saturation (Vital Sign)
PercentAZD8601 3 mgPlacebo
Baseline96.0100.0
Day 197.6 ± 4.4699.3 ± 0.80
Day 297.7 ± 1.6897.4 ± 2.42
Day 395.6 ± 2.1496.6 ± 3.60
Day 495.7 ± 1.8595.8 ± 3.74
PrimarySystolic Blood Pressure (Vital Sign)
Time frame:
From baseline to end of follow up at 6 months
Reported as:
Mean · mmHg
Systolic Blood Pressure (Vital Sign)
mmHgAZD8601 3 mgPlacebo
Baseline141.1 ± 24.42141.7 ± 23.32
Day 1113.5 ± 5.67116.8 ± 12.53
Day 2118.1 ± 11.98104.8 ± 4.39
Day 3118.5 ± 8.04100.8 ± 10.82
Day 4129.1 ± 16.63109.0 ± 6.48
Visit 5 (Day 30)135.9 ± 17.56134.5 ± 29.49
Visit 6 (Day 91)146.3 ± 11.76163.0 ± 35.39
Visit 7 (Day 182)142.3 ± 13.00147.3 ± 34.07
PrimaryNumber of Subjects With High Values of Erythrocytes, Particle Concentration

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Erythrocytes, Particle Concentration
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryDiastolic Blood Pressure (Vital Sign)
Time frame:
From baseline to end of follow up at 6 months
Reported as:
Mean · mmHg
Diastolic Blood Pressure (Vital Sign)
mmHgAZD8601 3 mgPlacebo
Baseline82.1 ± 17.9574.5 ± 23.57
Day 159.2 ± 6.5262.0 ± 7.63
Day 259.2 ± 10.6258.0 ± 5.12
Day 363.7 ± 8.6456.9 ± 2.83
Day 473.7 ± 11.0766.8 ± 5.91
Visit 5 (Day 30)78.1 ± 10.1683.5 ± 14.55
Visit 6 (Day 91)80.0 ± 7.0993.8 ± 16.62
Visit 7 (Day 182)79.4 ± 8.0683.5 ± 19.60
PrimaryNumber of Subjects With High Values of Erythrocyte, Volume Fraction

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Erythrocyte, Volume Fraction
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Erythrocytes, Mean Cell Volume

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Erythrocytes, Mean Cell Volume
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment10
PrimaryNumber of Subjects With High Values of Hemoglobin

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Hemoglobin
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Neutrophils

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Neutrophils
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment20
PrimaryNumber of Subjects With High Values of Lymphocytes

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Lymphocytes
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Monocytes

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Monocytes
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment01
PrimaryNumber of Subjects With High Values of Eosinophils

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Eosinophils
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Basophils

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Basophils
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Platelets

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Platelets
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Reticulocytes

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Reticulocytes
Number of subjectsAZD8601 3 mgPlacebo
Baseline11
Maximum value during treatment10
PrimaryNumber of Subjects With High Values of Prothrombin Complex INR

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Prothrombin Complex INR
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Activated Partial Thromboplastin Time

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Activated Partial Thromboplastin Time
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Fibrinogen

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Fibrinogen
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment32
PrimaryNumber of Subjects With High Values of Sodium

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Sodium
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Potassium

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Potassium
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Urea

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Urea
Number of subjectsAZD8601 3 mgPlacebo
Baseline01
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Creatinine

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Creatinine
Number of subjectsAZD8601 3 mgPlacebo
Baseline11
Maximum value during treatment11
PrimaryNumber of Subjects With High Values of Albumin

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Albumin
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Calcium

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Calcium
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Phosphate

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Phosphate
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Alkaline Phosphatase

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Alkaline Phosphatase
Number of subjectsAZD8601 3 mgPlacebo
Baseline01
Maximum value during treatment01
PrimaryNumber of Subjects With High Values of Alanine Aminotransferase

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Alanine Aminotransferase
Number of subjectsAZD8601 3 mgPlacebo
Baseline01
Maximum value during treatment00
PrimaryNumber of Subjects With High Values of Aspartate Aminotransferase

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Aspartate Aminotransferase
Number of subjectsAZD8601 3 mgPlacebo
Baseline11
Maximum value during treatment01
PrimaryNumber of Subjects With High Values of Bilirubin, Total

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Time frame:
From baseline to end of follow up at 6 months
Reported as:
Number · Number of subjects
Number of Subjects With High Values of Bilirubin, Total
Number of subjectsAZD8601 3 mgPlacebo
Baseline00
Maximum value during treatment10

Adverse events

Collected over All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AZD8601 3mg0/7 (0%)3/7 (42.9%)7/7 (100%)
Placebo0/4 (0%)1/4 (25%)4/4 (100%)
Most frequent serious events
Most frequent serious events
EventAZD8601 3mgPlacebo
Skin necrosisSkin and subcutaneous tissue disorders0/71/4
AnaemiaBlood and lymphatic system disorders1/70/4
Incision site impaired healingInjury, poisoning and procedural complications1/70/4
Incision site inflammationInjury, poisoning and procedural complications1/70/4
Vascular graft occlusionInjury, poisoning and procedural complications1/70/4
Embolic cerebral infarctionNervous system disorders1/70/4
CoagulopathyBlood and lymphatic system disorders1/70/4
Most frequent other events
Showing 10 of 31
Most frequent other events
EventAZD8601 3mgPlacebo
AnaemiaBlood and lymphatic system disorders1/72/4
Pleural effusionRespiratory, thoracic and mediastinal disorders0/72/4
Atrial fibrillationCardiac disorders2/72/4
Non-cardiac chest painGeneral disorders0/71/4
PyrexiaGeneral disorders0/71/4
Urinary tract infectionInfections and infestations0/71/4
Wound infectionInfections and infestations0/71/4
Procedural painInjury, poisoning and procedural complications0/71/4
Liver function test increasedInvestigations0/71/4
DyslipidaemiaMetabolism and nutrition disorders0/71/4

Baseline characteristics

Age, Continuous
Age, Continuous(Years)AZD8601 3mgPlaceboTotal
Mean68.3 ± 5.867.8 ± 10.868.1 ± 7.45
Sex: Female, Male
Sex: Female, Male(Participants)AZD8601 3mgPlaceboTotal
Female022
Male729
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AZD8601 3mgPlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White7411
More than one race000
Unknown or Not Reported000
08

Study locations

10 sites
  • Research Site
    New Haven, Connecticut 06510, United States
  • Research Site
    Kuopio, 70210, Finland
  • Research Site
    Tampere, 33520, Finland
  • Research Site
    Turku, 20520, Finland
  • Research Site
    München, 80363, Germany
  • Research Site
    München, 81675, Germany
  • Research Site
    Amsterdam, 1081 HV, Netherlands
  • Research Site
    Groningen, 9713 GZ, Netherlands
  • Research Site
    Gothenburg, 413 45, Sweden
  • Research Site
    Uppsala, 751 85, Sweden
09

References and documents

Publications

  • Anttila V, Saraste A, Knuuti J, Hedman M, Jaakkola P, Laugwitz KL, Krane M, Jeppsson A, Sillanmaki S, Rosenmeier J, Zingmark P, Rudvik A, Garkaviy P, Watson C, Pangalos MN, Chien KR, Fritsche-Danielson R, Collen A, Gan LM. Direct intramyocardial injection of VEGF mRNA in patients undergoing coronary artery bypass grafting. Mol Ther. 2023 Mar 1;31(3):866-874. doi: 10.1016/j.ymthe.2022.11.017. Epub 2022 Dec 17. PubMed 36528793 ↗
  • Anttila V, Saraste A, Knuuti J, Jaakkola P, Hedman M, Svedlund S, Lagerstrom-Fermer M, Kjaer M, Jeppsson A, Gan LM. Synthetic mRNA Encoding VEGF-A in Patients Undergoing Coronary Artery Bypass Grafting: Design of a Phase 2a Clinical Trial. Mol Ther Methods Clin Dev. 2020 Jun 1;18:464-472. doi: 10.1016/j.omtm.2020.05.030. eCollection 2020 Sep 11. PubMed 32728595 ↗

Study documents

  • Study protocol · Feb 27, 2020
  • Statistical analysis plan · Jul 19, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Statistical analysis plan

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Jun 2021, 40 months.

Results were first posted in Oct 2024, 3 years 3 months after primary completion.

Of 67 industry-sponsored phase 2 interventional studies under Heart Failure, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 29. This study's 40 months is above that.

Counting every sponsor, half of 172 studies reached it within 26 months; a quarter within 16 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2017
First posted
Dec 13, 2017
StartActual
Feb 5, 2018
Primary completionActual
Jun 30, 2021
CompletionActual
Jun 30, 2021
Results first posted
Oct 10, 2024
Last update
Oct 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03370887
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 13, 2017
Start date
Feb 5, 2018
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021
Results posted
Oct 10, 2024
Last update
Oct 10, 2024

Study contacts

Vesa Anttila, MD, PhD
principal investigator · Heart Center, Turku University, Finland

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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