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Low enrollment
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Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2) placebo.
This is a double-blind randomized clinical trial of evolocumab versus placebo in patients with ASCVD and DM on clopidogrel and aspirin undergoing PCI. The study is aimed to assess
Eligible patients will be randomized prior to start the PCI equally to either:
The laboratory assessments will be performed before (baseline), and 16-24 hours and 30-days after randomization.
Subject participation will be 30 days from the randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| evolocumab 420mg | Active Comparator | 75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg. |
|
| placebo | Placebo Comparator | 75 subjects on optimal statin therapy undergoing elective PCI will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | Patients will receive evolocumab 420 mg administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression | Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo). | Baseline and after 30 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ADP-unstimulated P-selectin Expression | Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo) | Baseline and after 30 days of treatment |
| Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
A total of 31 participants were screened, 4 met eligibility and were randomized to the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evolocumab 420mg | Participants on optimal statin therapy undergoing elective percutaneous coronary intervention (PCI) will receive evolocumab 420mg. Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously |
| FG001 | Placebo | Participants on optimal statin therapy undergoing elective percutaneous coronary intervention (PCI) will receive placebo Placebo: Participants will receive placebo administered subcutaneously |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Evolocumab 420mg | Participants on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg. Evolocumab: Participants will receive evolocumab 420 mg administered subcutaneously |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression | Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo). | Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group. | Posted | Mean | Standard Deviation | % Positive Cells | Baseline and after 30 days of treatment |
|
30 Days
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a drug. This includes any newly occurring event that has increased in severity or frequency since the administration of the study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evolocumab 420mg | 75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg. Evolocumab: Patients will receive evolocumab 420 mg administered subcutaneously |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Non-systematic Assessment | Chest pain requiring hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Study was terminated early as a result of 1) low enrollment and , 2) thrombosis research center moving to another health system (LifeBridge Health) . Only 4 patients were enrolled, as a result we were not able to conduct an analysis on any of the endpoints.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Sinai Center for Thrombosis Research | 443-244-1497 | kpbliden@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2018 | Mar 15, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2019 | Dec 2, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
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| Placebo | Drug | Patients will receive placebo administered subcutaneously |
|
Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo) |
| Baseline and after 30 days of treatment |
| Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI | Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo) | Baseline and after 30 days of treatment |
Participants on optimal statin therapy undergoing elective PCI will receive placebo
Placebo: Participants will receive placebo administered subcutaneously
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants on optimal statin therapy undergoing elective PCI will receive placebo Placebo: Participants will receive placebo administered subcutaneously |
|
|
| Secondary | Change in ADP-unstimulated P-selectin Expression | Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo) | Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group. | Posted | Mean | Standard Deviation | % Positive Cells | Baseline and after 30 days of treatment |
|
|
|
| Secondary | Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI) | Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo) | Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group. | Posted | Mean | Standard Deviation | MFI | Baseline and after 30 days of treatment |
|
|
|
| Secondary | Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI | Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo) | Instrument malfunction with flow cytometer. Unable to collect data from subject (n=1) in placebo group. | Posted | Mean | Standard Deviation | MFI | Baseline and after 30 days of treatment |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 1 |
| 3 |
| EG001 | Placebo | 75 subjects on optimal statin therapy undergoing elective PCI will receive placebo Placebo: Patients will receive placebo administered subcutaneously | 0 | 1 | 0 | 1 | 0 | 1 |
|
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| D004700 | Endocrine System Diseases |