Myocardial InfarctionPhase 4EARLYNCT03750760
Early Alirocumab to Reduce LDL-C in Myocardial Infarction
A Phase 4 study testing Alirocumab, Atorvastatin 80mg and Ezetimibe 10mg in people with Myocardial Infarction and Dyslipidemias, run by Imperial College London at 17 sites in United Kingdom.
Trial summary
The EARLY trial is a phase IV, investigator initiated, international, multicentre study that will investigate if early use of alirocumab 150mg plus atorvastatin 80mg (enhanced care) will have a greater effect than atorvastatin 80mg (standard care) on the reduction of LDL-C at 2-weeks after a myocardial infarction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Dyslipidemias
- What is being tested?
- Alirocumab, Atorvastatin 80mg and Ezetimibe 10mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- Jan 2020to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 years or above
- Admitted to hospital for ST-Segment Elevation MI (STEMI) or non-ST-Segment Elevation MI (NSTEMI) (proven by electrocardiogram (ECG) or biomarker evidence of MI)
- Statin naïve prior to MI
- Local LDL-C measurement available within 24 hrs of chest pain with no more than 1 dose of statin
- Ability and willingness to give written informed consent and to comply with the requirements of the study
Who cannot join
- No ECG or biomarker evidence of MI
- Received more than one dose of statin during the index event prior to randomisation
- Contraindication to atorvastatin 80mg
- Contraindication to ezetimibe
- Contraindication to alirocumab
- Unwillingness or inability to comply with study requirements, particularly with respect to laboratory tests, specifically blood draws 24 and 48 hours after randomisation, and subsequent clinic visits
Show all 11Show fewer
- New York Heart Association (NYHA) Class IV Heart Failure
- Unstable arrhythmia
- Subjects who in the opinion of investigator have a life expectancy of < 9 weeks
- Women of child bearing age who are not using at least 2 methods of contraception
- Pregnant or breastfeeding.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Basildon Hospital
Basildon, Essex, SS16 5NL
Queen Elizabeth Medical Centre
Birmingham, West Midlands, B15 2TH
City Hospital
Birmingham, West Midlands, B18 7QH
The Royal Bournemouth General Hospital
Bournemouth, Dorset, BH7 7DW
St Peters Hospital
Chertsey, Surrey, KT16 0PZ
Royal Devon & Exeter Hospital
Exeter, Devon, EX2 5DW
Northwick Park Hospital
Harrow, Middlesex, HA1 3UJ
Hull Royal Infirmary
Hull, North Humberside, HU3 2JZ
St Mary's Hospital
London, Greater London, W2 1NY
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
East Surrey Hospital
Redhill, Surrey, RH1 5RH
East Sussex Healthcare NHS Trust
Saint Leonards-on-Sea, East Sussex, TN37 7PT
Northern General Hospital
Sheffield, Yorkshire, S5 7AU
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Worchestershire Royal Hospital
Worcester, Worcestershire, WR5 1DD
About this study
The EARLY trial is a phase IV, investigator initiated, international, multicentre study that will investigate if early use of alirocumab 150mg plus atorvastatin 80mg (enhanced care) will have a greater effect than atorvastatin 80mg (standard care) on the reduction of LDL-C at 2-weeks after a myocardial infarction (MI), in patients who start treatment within 24 hours of symptom onset.
A secondary goal is to assess the effects of enhanced care when compared to standard care which is either atorvastatin alone or atorvastatin plus ezetimibe, (the latter added at 4 weeks if LDL-C is ≥ 70mg/dL (1.8mmol/L), on the proportion of patients achieving an LDL-C goal of < 50mg/dL (1.29 mmol/L) at 7 weeks after an MI.
Read the detailed description
Patients with Acute Coronary Syndrome (ACS), which includes myocardial infarction, are at high risk of recurrent ischaemic events (e.g. heart attacks), and death. The current standard treatment includes high dose statins to lower low-density lipoprotein cholesterol (LDL-C), also known as bad cholesterol, soon after admission. In some cases, following assessment after 1-3 months, administration of a second line cholesterol lowering therapy (ezetimibe) may be added if LDL-C levels remain high ≥ 70mg/dL (1.8mmol/L). Many guidelines advocate that following ACS high dose statins should be used as first line therapy. If LDL-C levels remain greater than 70mg/dL (1.8mmol/L) then additional add on therapy on statins could be considered for ACS patients.
Consented patients meeting the eligibility criteria for the EARLY trial will be randomised to enhanced care or standard care within 24hrs of symptom onset for MI. Patients randomised to enhanced care will receive alirocumab 150 mg on randomisation and then every 2 weeks during a 7-week treatment period. All patients will receive atorvastatin 80 mg. Patients randomised to standard care with an LDL-C level ≥ 70mg/dL (1.8mmol/L) at week 4 will receive ezetimibe 10 mg, in addition to atorvastatin 80 mg for the remaining duration of the treatment period.
All patients will be followed up for a two-week period after completing the 7-week treatment period (i.e. a total of 9 weeks to assess safety).
- Conditions
- Myocardial Infarction, Dyslipidemias
- Being tested
- Alirocumab, Atorvastatin 80mg, Ezetimibe 10mg
- Medical subject headings
- Myocardial Infarction, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
Also called Praluent
PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody
Atorvastatin 80mgDrug
3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin)
Ezetimibe 10mgDrug
Cholesterol absorption inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Alirocumab (enhanced care) | Active comparator | Alirocumab (150 mg) administered by subcutaneous injection, every two weeks for 7 weeks.
Atorvastatin (80 mg), oral administration daily. Receives: Drug: Alirocumab; Drug: Atorvastatin 80mg |
| Atorvastatin (standard care) | Active comparator | Atorvastatin (80 mg), oral administration daily. Ezetimibe (10 mg), oral administration daily, from week 4 if LDL-C is ≥ 70 mg/dL (1.8mmol/L) at week 4. Receives: Drug: Atorvastatin 80mg; Drug: Ezetimibe 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in LDL-C in enhanced care group verses standard of care group at 2 weeks after randomisation
Measured: 2 weeks from baseline
Secondary outcomes (6)
Percentage change in LDL-C at 7 weeks in enhanced care verses standard of care.
Measured: 7 weeks from baseline
Proportion of patients who achieve a LDL < 50mg/dL (1.29mmol/L) at week 2, 4 and 7 in enhanced care verses standard of care
Measured: 2, 4 and 7 weeks from baseline
Proportion of patients in standard of care who need ezetimibe 10 mg to be added in the standard of care pathway at week 4
Measured: 4 weeks from baseline
Proportion of patients with reported adverse events (AEs)
Measured: 7 and 9 weeks from baseline
Proportion of patients with reported serious adverse events (SAEs)
Measured: 7 and 9 weeks from baseline
Proportion of patients with reported adverse events of special interest (AESIs)
Measured: 7 and 9 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startJan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Changes in funding decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Baim Institute for Clinical Research
- Responsible party
- Sponsor
- Investigators
- Kausik Ray, Professor, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750760
- Sponsor's protocol ID
- 18HH4627
- Other IDs
- 2018-002429-49, 2018
- Acronym
- EARLY
- Status last verified
- Jun 2019
- First submitted
- 19 Nov 2018
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Alirocumab to Reduce LDL-C in Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03750760
- Acronym / sponsor ID
- EARLY / 18HH4627
- Conditions
- Myocardial Infarction, Dyslipidemias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in funding decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Baim Institute for Clinical Research
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EARLY trial is a phase IV, investigator initiated, international, multicentre study that will investigate if early use of alirocumab 150mg plus atorvastatin 80mg (enhanced care) will have a greater effect than atorvastatin 80mg (standard care) on the reduction of LDL-C at 2-weeks after a myocardial infarction (MI), in patients who start treatment within 24 hours of symptom onset.
A secondary goal is to assess the effects of enhanced care when compared to standard care which is either atorvastatin alone or atorvastatin plus ezetimibe, (the latter added at 4 weeks if LDL-C is ≥ 70mg/dL (1.8mmol/L), on the proportion of patients achieving an LDL-C goal of < 50mg/dL (1.29 mmol/L) at 7 weeks after an MI.
Detailed description
Patients with Acute Coronary Syndrome (ACS), which includes myocardial infarction, are at high risk of recurrent ischaemic events (e.g. heart attacks), and death. The current standard treatment includes high dose statins to lower low-density lipoprotein cholesterol (LDL-C), also known as bad cholesterol, soon after admission. In some cases, following assessment after 1-3 months, administration of a second line cholesterol lowering therapy (ezetimibe) may be added if LDL-C levels remain high ≥ 70mg/dL (1.8mmol/L). Many guidelines advocate that following ACS high dose statins should be used as first line therapy. If LDL-C levels remain greater than 70mg/dL (1.8mmol/L) then additional add on therapy on statins could be considered for ACS patients.
Consented patients meeting the eligibility criteria for the EARLY trial will be randomised to enhanced care or standard care within 24hrs of symptom onset for MI. Patients randomised to enhanced care will receive alirocumab 150 mg on randomisation and then every 2 weeks during a 7-week treatment period. All patients will receive atorvastatin 80 mg. Patients randomised to standard care with an LDL-C level ≥ 70mg/dL (1.8mmol/L) at week 4 will receive ezetimibe 10 mg, in addition to atorvastatin 80 mg for the remaining duration of the treatment period.
All patients will be followed up for a two-week period after completing the 7-week treatment period (i.e. a total of 9 weeks to assess safety).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alirocumab (enhanced care) | Active comparator | Drug: Alirocumab, Drug: Atorvastatin 80mgAlirocumab (150 mg) administered by subcutaneous injection, every two weeks for 7 weeks. Atorvastatin (80 mg), oral administration daily. |
| Atorvastatin (standard care) | Active comparator | Drug: Atorvastatin 80mg, Drug: Ezetimibe 10mgAtorvastatin (80 mg), oral administration daily. Ezetimibe (10 mg), oral administration daily, from week 4 if LDL-C is ≥ 70 mg/dL (1.8mmol/L) at week 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females aged 18 years or above
- Admitted to hospital for ST-Segment Elevation MI (STEMI) or non-ST-Segment Elevation MI (NSTEMI) (proven by electrocardiogram (ECG) or biomarker evidence of MI)
- Statin naïve prior to MI
- Local LDL-C measurement available within 24 hrs of chest pain with no more than 1 dose of statin
- Ability and willingness to give written informed consent and to comply with the requirements of the study
Key exclusion criteria (11 listed)
- No ECG or biomarker evidence of MI
- Received more than one dose of statin during the index event prior to randomisation
- Contraindication to atorvastatin 80mg
- Contraindication to ezetimibe
- Contraindication to alirocumab
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 |
|---|---|---|
| AlirocumabAlso: PraluentPCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody | Drug | Alirocumab (enhanced care) |
| Atorvastatin 80mg3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin) | Drug | Alirocumab (enhanced care), Atorvastatin (standard care) |
| Ezetimibe 10mgCholesterol absorption inhibitor | Drug | Atorvastatin (standard care) |
Primary outcome
Percentage change in LDL-C in enhanced care group verses standard of care group at 2 weeks after randomisation
Time frame: 2 weeks from baseline
6 secondary outcomes
Percentage change in LDL-C at 7 weeks in enhanced care verses standard of care.
Time frame: 7 weeks from baseline
Proportion of patients who achieve a LDL < 50mg/dL (1.29mmol/L) at week 2, 4 and 7 in enhanced care verses standard of care
Time frame: 2, 4 and 7 weeks from baseline
Proportion of patients in standard of care who need ezetimibe 10 mg to be added in the standard of care pathway at week 4
Time frame: 4 weeks from baseline
Proportion of patients with reported adverse events (AEs)
Time frame: 7 and 9 weeks from baseline
Proportion of patients with reported serious adverse events (SAEs)
Time frame: 7 and 9 weeks from baseline
Proportion of patients with reported adverse events of special interest (AESIs)
Time frame: 7 and 9 weeks from baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Kausik Ray, Professor principal investigator
Imperial College London
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alirocumab, Atorvastatin 80mg and Ezetimibe 10mg in people with Myocardial Infarction and Dyslipidemias, run by Imperial College London at 17 sites in United Kingdom.
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 11 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: withdrawn, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage change in LDL-C in enhanced care group verses standard of care group at 2 weeks after randomisation (time frame: 2 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2019.