Heart FailurePhase 2NCT03370887

AZD8601 Study in CABG Patients

A Phase 2 study testing AZD8601 in people with Heart Failure, run by AstraZeneca at 10 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Heart Failure
What is being tested?: AZD8601
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 10 sitesin 5 countries
Study dates: 5 Feb 2018to 30 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 10Show fewer

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.

Trial locations and contacts

10 sites in 5 countries.

Country

City, postcode or hospital

10 sites in 5 countries

Finland3 sites

Research Site
Kuopio, 70210
Research Site
Tampere, 33520
Research Site
Turku, 20520

Other trials in Finland

Germany2 sites

Research Site
München, 80363
Research Site
München, 81675

Other trials in Germany

Netherlands2 sites

Research Site
Amsterdam, 1081 HV
Research Site
Groningen, 9713 GZ

Other trials in Netherlands

Sweden2 sites

Research Site
Gothenburg, 413 45
Research Site
Uppsala, 751 85

Other trials in Sweden

United States1 site

Research Site
New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-centre, Sequential Design, Phase IIa Study to Evaluate Safety and Tolerability of Epicardial Injections of AZD8601 During Coronary Artery Bypass Grafting Surgery

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.

Conditions: Heart Failure
Being tested: AZD8601, Placebo
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD8601Drug
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
PlaceboDrug
Placebo for AZ8601 injection for solution will be given as 30 injections per patient on a single occasion

Study groups in NCT03370887
Study group	Role	What they receive
Low dose AZD8601 (3 mg)	Experimental	8 patients will be randomised to receive 3 mg AZD8601 Receives: Drug: AZD8601
High dose AZD8601 (30 mg)	Experimental	8 patients will be randomised to receive 30 mg AZD8601 Receives: Drug: AZD8601
Placebo	Placebo comparator	8 patients will be randomised to receive placebo injections Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Adverse Events
Measured: From baseline to end of follow up at 6 months
Pulse Rate (Vital Sign)
Measured: From baseline to end of follow up at 6 months
Number of Subjects With an ECG Determined to be Abnormal and Clinically Significant
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
Oxygen Saturation (Vital Sign)
Measured: From baseline to end of follow up at 6 months
Systolic Blood Pressure (Vital Sign)
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
Diastolic Blood Pressure (Vital Sign)
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months
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.
Measured: From baseline to end of follow up at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 201830 Jun 2021

First posted13 Dec 2017
Study start5 Feb 2018
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03370887
Sponsor's protocol ID: D9150C00003
Status last verified: Jun 2024
First submitted: 16 Nov 2017
Last updated: 10 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-centre, Sequential Design, Phase IIa Study to Evaluate Safety and Tolerability of Epicardial Injections of AZD8601 During Coronary Artery Bypass Grafting Surgery
ClinicalTrials.gov ID: NCT03370887
Acronym / sponsor ID: D9150C00003
Conditions: Heart Failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 5 Feb 2018 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 13 Dec 2017 (actual)
Results: Posted 10 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Low dose AZD8601 (3 mg)	Experimental	Drug: AZD86018 patients will be randomised to receive 3 mg AZD8601
High dose AZD8601 (30 mg)	Experimental	Drug: AZD86018 patients will be randomised to receive 30 mg AZD8601
Placebo	Placebo comparator	Drug: Placebo8 patients will be randomised to receive placebo injections

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 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.

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD8601AZD8601 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	Drug	High dose AZD8601 (30 mg), Low dose AZD8601 (3 mg)
PlaceboPlacebo for AZ8601 injection for solution will be given as 30 injections per patient on a single occasion	Drug	Placebo

Primary outcome

Number of Subjects With Adverse Events
Time frame: From baseline to end of follow up at 6 months
Pulse Rate (Vital Sign)
Time frame: From baseline to end of follow up at 6 months
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
Number of Subjects With High Values of Leukocytes, Particle Concentration
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Oxygen Saturation (Vital Sign)
Time frame: From baseline to end of follow up at 6 months
Systolic Blood Pressure (Vital Sign)
Time frame: From baseline to end of follow up at 6 months
Number of Subjects With High Values of Erythrocytes, Particle Concentration
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Diastolic Blood Pressure (Vital Sign)
Time frame: From baseline to end of follow up at 6 months
Number of Subjects With High Values of Erythrocyte, Volume Fraction
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Erythrocytes, Mean Cell Volume
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Hemoglobin
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Neutrophils
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Lymphocytes
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Monocytes
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Eosinophils
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Basophils
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Platelets
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Reticulocytes
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Prothrombin Complex INR
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Activated Partial Thromboplastin Time
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Fibrinogen
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Sodium
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Potassium
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Urea
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Creatinine
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Albumin
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Calcium
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Phosphate
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Alkaline Phosphatase
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Alanine Aminotransferase
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Aspartate Aminotransferase
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
Number of Subjects With High Values of Bilirubin, Total
Time frame: From baseline to end of follow up at 6 months
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Results and safety

Results posted to the registry on 10 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD8601 3mg	7	7
Placebo	4	4

Primary outcome: Number of Subjects With Adverse Events

Time frame: From baseline to end of follow up at 6 months. Count of participants. Unit: Participants

Measure	AZD8601 3 mg n = 7	Placebo n = 4
Value	7	4

Primary outcome: Pulse Rate (Vital Sign)

Time frame: From baseline to end of follow up at 6 months. Mean (Standard Deviation). Unit: beats/min

Measure	AZD8601 3 mg n = 7	Placebo n = 4
Baseline	63.1 (10.42)	62.6 (6.04)
Day 1	81.3 (7.38)	75.2 (4.20)
Day 2	85.2 (5.54)	81.1 (7.01)
Day 3	83.6 (8.38)	82.4 (6.80)
Day 4	81.9 (14.54)	75.3 (7.63)
Visit 5 (Day 30)	74.3 (13.33)	65.5 (6.81)
Visit 6 (Day 91)	66.9 (15.05)	70.8 (7.18)
Visit 7 (Day 182)	63.6 (15.62)	61.0 (2.16)

Primary outcome: 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. Count of participants. Unit: Participants

Measure	AZD8601 3 mg n = 7	Placebo n = 4
Baseline	0	0
End of treatment	1	0

Primary outcome: Number of Subjects With High Values of Leukocytes, Particle Concentration

Time frame: From baseline to end of follow up at 6 months. Number. Unit: Number of subjects

Measure	AZD8601 3 mg n = 6	Placebo n = 4
Baseline	0	0
Maximum value during treatment	3	1

Population analysed: For some participants laboratory analysis have not been made

Adverse events

Time frame: All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD8601 3mg	3 of 7 (42.9%)	7 of 7 (100%)	0 of 7
Placebo	1 of 4 (25%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36528793Anttila 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.
Derived from this study: PubMed 32728595Anttila 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.
CSP redactedLink provided by the sponsor.
SAP redactedLink provided by the sponsor.
CSR synopsis redactedLink provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vesa Anttila, MD, PhD principal investigator

Heart Center, Turku University, Finland

10 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD8601 in people with Heart Failure, run by AstraZeneca at 10 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Finland, Germany, Netherlands, Sweden, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Adverse Events (time frame: From baseline to end of follow up at 6 months). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03370887, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.