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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alirocumab | Experimental |
| |
| Sham Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alirocumab | Drug | 150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in direct LDL cholesterol | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in Apo B | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shamir Mehta, MD MSc FRCPC | Population Health Research Institute; McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences, General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36349701 | Derived | 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. |
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A randomized, double-blind, sham-controlled parallel group clinical trial.
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| Sham Control | Other | Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure. |
|
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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