Coronary Artery DiseasePhase 2FLAVOURNCT03317002
AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
A Phase 2 study testing AZD5718 in people with Coronary Artery Disease, run by AstraZeneca at 9 sites in 3 countries.
Trial 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 138 CAD patients will be randomized to AZD5718 or placebo (treatment duration 12 weeks). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- AZD5718
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 30 Oct 2017to 8 Apr 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Sweden4 sites
Research Site
Gothenburg, 413 45
Research Site
Lund, 222 42
Research Site
Stockholm, 171 76
Research Site
Uppsala, 75185
Denmark3 sites
Research Site
Aarhus, 8200
Research Site
Frederiksberg, 2000
Research Site
Odense C, 5000
About this study
Official title: 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)
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 138 CAD patients will be randomized to AZD5718 or placebo (treatment duration 12 weeks).
Read the 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 and Sweden).
Patients suitable for the study will be identified and screened for eligibility after being hospitalized for Acute Coronary Syndrome (ACS) (Visit 1) comprising ST Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (non-STEMI). At Visit 1, after signing informed consent, study measurements will take place at days 1, 2, 3 and 5 post ACS, where feasible. It is planned that approximately 138 CAD patients will be randomized to ensure at least 66 evaluable patients receiving AZD5718 Dose B or placebo are included with 12 weeks treatment. For supporting dose selection in future studies, a treatment arm with 28 randomized patients receiving AZD5718 Dose A is included in the study. The study was originally designed to be a 4-week study and was amended to be a 12-week study. Therefore, the total number of patients is greater than required for a 12 weeks study (about 100), since some patients will only have 4 weeks of treatment.
An evaluable patient is defined as a patient with a valid Coronary Flow Velocity Reserve (CFVR) measurement at Visit 2 and one post baseline visit as judged by the CFVR Core lab.
On Day 1 (Visit 2), 7 to 28 days after the ACS event, patients willing to participate in the study will complete the screening procedure and, if eligible, be randomized. Treatment duration will be 12 weeks. During the treatment phase, patients will come in to the clinic for study measurements at 2 weeks (visit 3), 4 weeks (visit 4), 8 weeks (visit 4b) and 12 weeks (visit 4c).
A follow-up visit (Visit 5) will be performed at 4 weeks (±4 days) after last dose in order to ensure safety and well-being of the patients
- Conditions
- Coronary Artery Disease
- Being tested
- AZD5718, Placebo
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5718Drug
Oral dose of AZD5718 (tablet)
AZD5718Drug
Oral dose of AZD5718 (tablet)
PlaceboDrug
Matching placebo (tablet)
| Study group | Role | What they receive |
|---|---|---|
| AZD5718 Dose A | Experimental | AZD5718 Dose A once daily Receives: Drug: AZD5718 |
| AZD5718 Dose B | Experimental | AZD5718 Dose B once daily Receives: Drug: AZD5718 |
| Placebo | Placebo comparator | Matching placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Creatinine-normalized u-LTE4 at Week 4
Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine
Measured: Baseline and 4 weeks
Secondary outcomes (10)
Change From Baseline in Creatinine-normalized u-LTE4 at Week 12
Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine
Measured: Baseline and 12 weeks
Change From Baseline in CFVR at Week 12
CFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest)
Measured: Baseline and 12 weeks
Change From Baseline in CFVR at Week 4
CFVR = Coronary Flow Velocity Reserve = LAD(hyperaemic)/LAD(rest)
Measured: Baseline and 4 weeks
Summary of Plasma Concentrations of AZD5718
Measured: 16 weeks
Change From Baseline in LAD Hypereamic Flow at 4 Weeks
LAD=Left Anterior Descending
Measured: Baseline and 4 weeks
Change From Baseline in LVEF at 4 Weeks
LVEF=Left Ventricular Ejection Fraction
Measured: Baseline and 4 weeks
Change From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 Weeks
LV=Left Ventricular
Measured: Baseline and 4 weeks
Change From Baseline in LV-GLS at Rest at Week 4
LV-GLS = Left Ventricular Global Longitudinal Strain
Measured: Baseline and 4 weeks
Change From Baseline in LV-GCS at Rest at Week 4
LV-GCS = Left Ventricular Global Circumferential Strain
Measured: Baseline and 4 weeks
Change From Baseline in LAD Resting Mean Diastolic Flow Velocity at 4 Weeks
LAD=Left Anterior Descending
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start30 Oct 2017
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317002
- Sponsor's protocol ID
- D7550C00003
- Acronym
- FLAVOUR
- Status last verified
- Jun 2021
- First submitted
- 5 Oct 2017
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
Prescott E, Angeras O, Erlinge D, Grove EL, Hedman M, Jensen LO, Pernow J, Saraste A, Akerblom A, Svedlund S, Rudvik A, Knochel J, Lindstedt EL, Garkaviy P, Gan LM, Gabrielsen A. Safety and efficacy of the 5-lipoxygenase-activating protein inhibitor AZD5718 in patients with recent myocardial infarction: The phase 2a FLAVOUR study. Int J Cardiol. 2022 Oct 15;365:34-40. doi: 10.1016/j.ijcard.2022.07.016. Epub 2022 Jul 14.
PubMed 35842004
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03317002
- Acronym / sponsor ID
- FLAVOUR / D7550C00003
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Posted 30 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 138 CAD patients will be randomized to AZD5718 or placebo (treatment duration 12 weeks).
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 and Sweden).
Patients suitable for the study will be identified and screened for eligibility after being hospitalized for Acute Coronary Syndrome (ACS) (Visit 1) comprising ST Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (non-STEMI). At Visit 1, after signing informed consent, study measurements will take place at days 1, 2, 3 and 5 post ACS, where feasible. It is planned that approximately 138 CAD patients will be randomized to ensure at least 66 evaluable patients receiving AZD5718 Dose B or placebo are included with 12 weeks treatment. For supporting dose selection in future studies, a treatment arm with 28 randomized patients receiving AZD5718 Dose A is included in the study. The study was originally designed to be a 4-week study and was amended to be a 12-week study. Therefore, the total number of patients is greater than required for a 12 weeks study (about 100), since some patients will only have 4 weeks of treatment.
An evaluable patient is defined as a patient with a valid Coronary Flow Velocity Reserve (CFVR) measurement at Visit 2 and one post baseline visit as judged by the CFVR Core lab.
On Day 1 (Visit 2), 7 to 28 days after the ACS event, patients willing to participate in the study will complete the screening procedure and, if eligible, be randomized. Treatment duration will be 12 weeks. During the treatment phase, patients will come in to the clinic for study measurements at 2 weeks (visit 3), 4 weeks (visit 4), 8 weeks (visit 4b) and 12 weeks (visit 4c).
A follow-up visit (Visit 5) will be performed at 4 weeks (±4 days) after last dose in order to ensure safety and well-being of the patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZD5718 Dose A | Experimental | Drug: AZD5718AZD5718 Dose A once daily |
| AZD5718 Dose B | Experimental | Drug: AZD5718AZD5718 Dose B once daily |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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%
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 |
|---|---|---|
| AZD5718Oral dose of AZD5718 (tablet) | Drug | AZD5718 Dose A |
| AZD5718Oral dose of AZD5718 (tablet) | Drug | AZD5718 Dose B |
| PlaceboMatching placebo (tablet) | Drug | Placebo |
Primary outcome
Change From Baseline in Creatinine-normalized u-LTE4 at Week 4
Time frame: Baseline and 4 weeks
Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine
10 secondary outcomes
Change From Baseline in Creatinine-normalized u-LTE4 at Week 12
Time frame: Baseline and 12 weeks
Change From Baseline in CFVR at Week 12
Time frame: Baseline and 12 weeks
Change From Baseline in CFVR at Week 4
Time frame: Baseline and 4 weeks
Summary of Plasma Concentrations of AZD5718
Time frame: 16 weeks
Change From Baseline in LAD Hypereamic Flow at 4 Weeks
Time frame: Baseline and 4 weeks
Change From Baseline in LVEF at 4 Weeks
Time frame: Baseline and 4 weeks
Change From Baseline in LV Longitudinal Early Diastolic Strain Rate at 4 Weeks
Time frame: Baseline and 4 weeks
Change From Baseline in LV-GLS at Rest at Week 4
Time frame: Baseline and 4 weeks
Change From Baseline in LV-GCS at Rest at Week 4
Time frame: Baseline and 4 weeks
Change From Baseline in LAD Resting Mean Diastolic Flow Velocity at 4 Weeks
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35842004Prescott E, Angeras O, Erlinge D, Grove EL, Hedman M, Jensen LO, Pernow J, Saraste A, Akerblom A, Svedlund S, Rudvik A, Knochel J, Lindstedt EL, Garkaviy P, Gan LM, Gabrielsen A. Safety and efficacy of the 5-lipoxygenase-activating protein inhibitor AZD5718 in patients with recent myocardial infarction: The phase 2a FLAVOUR study. Int J Cardiol. 2022 Oct 15;365:34-40. doi: 10.1016/j.ijcard.2022.07.016. Epub 2022 Jul 14.
- redacted Statistical Analysis PlanLink provided by the sponsor.
- redacted Clinical Study ProtocolLink 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD5718 in people with Coronary Artery Disease, run by AstraZeneca at 9 sites in 3 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 14 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden, Denmark, Finland. 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 30 Jun 2021). 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?
Change From Baseline in Creatinine-normalized u-LTE4 at Week 4 (time frame: Baseline and 4 weeks). 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 NCT03317002, which also lists 1 linked publication.
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 30 Jun 2021; AzTrials last refreshed its copy on 5 Nov 2026.