ST Elevation Myocardial InfarctionPhase 2EPIC STEMINCT03718286
Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI
A Phase 2 study testing Alirocumab in people with ST Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Population Health Research Institute at 1 site in Canada.
Trial summary
A randomized, double-blind, placebo controlled parallel group clinical trial evaluating the effects of acute treatment with a PCSK9 inhibitor (alirocumab) versus placebo on low-density lipoprotein (LDL) in 100 high-risk patients presenting with STEMI and referred for primary PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Hypercholesterolemia
- What is being tested?
- Alirocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 11 Mar 2019to 8 Oct 2021
- Phase
- Phase 2
- 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
- Patients presenting with STEMI defined as both of the following: a) Symptoms of myocardial ischemia lasting for ≥ 30 minutes, and b) Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads.
- Referred for primary PCI for presenting symptoms.
- Randomized within 12 hours of symptom onset and prior to diagnostic angiography.
Who cannot join
- Age ≤18 years.
- Pregnancy or breastfeeding.
- Current or planned treatment with a PCSK9 inhibitor.
- Allergy or contra-indication to a PCSK9 inhibitor.
- Killip class ≥2.
- Known Creatinine clearance <30mL/min.
- Suspected takotsubo / stress-induced cardiomyopathy or acute pericarditis.
- Any other medical, geographic, or social factor making study participation impractical or precluding follow-up.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences, General Hospital
Hamilton, Ontario, L8L 2X2
About this study
Official title: Effects of Acute, Rapid Lowering of Low Density Lipoprotein Cholesterol With Alirocumab in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
A randomized, double-blind, placebo controlled parallel group clinical trial evaluating the effects of acute treatment with a PCSK9 inhibitor (alirocumab) versus placebo on low-density lipoprotein (LDL) in 100 high-risk patients presenting with STEMI and referred for primary PCI.
The objective is to determine the effect of acute, rapid lowering of LDL cholesterol with alirocumab added to high dose statin therapy in patients with STEMI undergoing primary PCI. The hypothesis is that, in patients with STEMI undergoing primary PCI, rapid lowering of LDL cholesterol with a PCSK9 Inhibitor (alirocumab) initiated in the acute setting pre-PCI, will favourably affect LDL cholesterol concentrations compared with placebo.
- Conditions
- ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Physiological Effects of Drugs
- Being tested
- Alirocumab, Sham Control
- Medical subject headings
- ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
Sham ControlOther
Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
| Study group | Role | What they receive |
|---|---|---|
| Alirocumab | Experimental | Not described Receives: Drug: Alirocumab |
| Sham Control | Sham comparator | Not described Receives: Other: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in direct LDL cholesterol
Measured: 6 weeks
Secondary outcomes (1)
Percent change in Apo B
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start11 Mar 2019
- Primary completion30 Jun 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, sham-controlled parallel group clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shamir Mehta, MD MSc FRCPC, Principal investigator, Population Health Research Institute; McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718286
- Sponsor's protocol ID
- EPIC.STEMI.2018
- Acronym
- EPIC STEMI
- Status last verified
- Mar 2022
- First submitted
- 23 Oct 2018
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mehta SR, Pare G, Lonn EM, Jolly SS, Natarajan MK, Pinilla-Echeverri N, Schwalm JD, Sheth TN, Sibbald M, Tsang M, Valettas N, Velianou JL, Lee SF, Ferdous T, Nauman S, Nguyen H, McCready T, McQueen MJ. Effects of routine early treatment with PCSK9 inhibitors in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a randomised, double-blind, sham-controlled trial. EuroIntervention. 2022 Dec 2;18(11):e888-e896. doi: 10.4244/EIJ-D-22-00735.
PubMed 36349701
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute, Rapid Lowering of Low Density Lipoprotein Cholesterol With Alirocumab in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03718286
- Acronym / sponsor ID
- EPIC STEMI / EPIC.STEMI.2018
- Conditions
- ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Physiological Effects of Drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 24 Oct 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.
A randomized, double-blind, placebo controlled parallel group clinical trial evaluating the effects of acute treatment with a PCSK9 inhibitor (alirocumab) versus placebo on low-density lipoprotein (LDL) in 100 high-risk patients presenting with STEMI and referred for primary PCI.
The objective is to determine the effect of acute, rapid lowering of LDL cholesterol with alirocumab added to high dose statin therapy in patients with STEMI undergoing primary PCI. The hypothesis is that, in patients with STEMI undergoing primary PCI, rapid lowering of LDL cholesterol with a PCSK9 Inhibitor (alirocumab) initiated in the acute setting pre-PCI, will favourably affect LDL cholesterol concentrations compared with placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, sham-controlled parallel group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Alirocumab | Experimental | Drug: Alirocumab |
| Sham Control | Sham comparator | Other: Sham Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting with STEMI defined as both of the following: a) Symptoms of myocardial ischemia lasting for ≥ 30 minutes, and b) Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads.
- Referred for primary PCI for presenting symptoms.
- Randomized within 12 hours of symptom onset and prior to diagnostic angiography.
Key exclusion criteria (8 listed)
- Age ≤18 years.
- Pregnancy or breastfeeding.
- Current or planned treatment with a PCSK9 inhibitor.
- Allergy or contra-indication to a PCSK9 inhibitor.
- Killip class ≥2.
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 |
|---|---|---|
| Alirocumab150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure. | Drug | Alirocumab |
| Sham ControlSham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure. | Other | Sham Control |
Primary outcome
Percent change in direct LDL cholesterol
Time frame: 6 weeks
1 secondary outcome
Percent change in Apo B
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 36349701Mehta SR, Pare G, Lonn EM, Jolly SS, Natarajan MK, Pinilla-Echeverri N, Schwalm JD, Sheth TN, Sibbald M, Tsang M, Valettas N, Velianou JL, Lee SF, Ferdous T, Nauman S, Nguyen H, McCready T, McQueen MJ. Effects of routine early treatment with PCSK9 inhibitors in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a randomised, double-blind, sham-controlled trial. EuroIntervention. 2022 Dec 2;18(11):e888-e896. doi: 10.4244/EIJ-D-22-00735.
- Individual participant dataSharing planned: Undecided
Related trials for ST Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation 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.
Shamir Mehta, MD MSc FRCPC principal investigator
Population Health Research Institute; McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alirocumab in people with ST Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Population Health Research Institute at 1 site in Canada.
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 3 inclusion and 8 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change in direct LDL cholesterol (time frame: 6 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 NCT03718286, 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 11 Apr 2022.