Diabetes Mellitus, Type 2Phase 4ISS-DMIINCT03258281
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
A Phase 4 study testing Evolocumab in people with Diabetes Mellitus, Type 2 and Dyslipidemia Associated With Type II Diabetes Mellitus, run by Inova Health Care Services at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus, Percutaneous Coronary Intervention
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Oct 2019
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes Mellitus
- Dyslipidemia
- Undergoing elective PCI
Who cannot join
- Patients with recent Acute Coronary Syndrome (≤1 month)
- Patients on dual antiplatelet treatment (DAPT) with ticagrelor or prasugrel
- Patients undergoing urgent/emergent PCI for stent thrombosis
- Severe acute or chronic medical or psychiatric condition
- Pregnancy
- Participation in another experimental clinical trial, without formal approval
- Unwillingness or inability to comply with the requirements of this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention
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.
Read the detailed description
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
- the effect of evolocumab therapy on platelet activation and reactivity;
- the effect of evolocumab on biomarkers of platelet activation and inflammation.
Eligible patients will be randomized prior to start the PCI equally to either:
- 420 mg evolocumab ; or
- placebo. The randomized treatment will be administered in subcutaneous injections.
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.
- Conditions
- Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus, Percutaneous Coronary Intervention
- Being tested
- Evolocumab, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Also called Repatha
Patients will receive evolocumab 420 mg administered subcutaneously
PlaceboDrug
Patients will receive placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| evolocumab 420mg | Active comparator | 75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg. Receives: Drug: Evolocumab |
| placebo | Placebo comparator | 75 subjects on optimal statin therapy undergoing elective PCI will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and after 30 days of treatment
Secondary outcomes (3)
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)
Measured: Baseline and after 30 days of treatment
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)
Measured: 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)
Measured: Baseline and after 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 May 2018
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Why it stopped: Low enrollment
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.
- Other trials for Diabetes Mellitus, Type 2Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258281
- Sponsor's protocol ID
- 17-2639
- Acronym
- ISS-DMII
- Status last verified
- Dec 2022
- First submitted
- 29 Jun 2017
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03258281
- Acronym / sponsor ID
- ISS-DMII / 17-2639
- Conditions
- Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Posted 19 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- the effect of evolocumab therapy on platelet activation and reactivity;
- the effect of evolocumab on biomarkers of platelet activation and inflammation.
Eligible patients will be randomized prior to start the PCI equally to either:
- 420 mg evolocumab ; or
- placebo. The randomized treatment will be administered in subcutaneous injections.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| evolocumab 420mg | Active comparator | Drug: Evolocumab75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg. |
| placebo | Placebo comparator | Drug: Placebo75 subjects on optimal statin therapy undergoing elective PCI will receive placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes Mellitus
- Dyslipidemia
- Undergoing elective PCI
Key exclusion criteria (7 listed)
- Patients with recent Acute Coronary Syndrome (≤1 month)
- Patients on dual antiplatelet treatment (DAPT) with ticagrelor or prasugrel
- Patients undergoing urgent/emergent PCI for stent thrombosis
- Severe acute or chronic medical or psychiatric condition
- Pregnancy
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 |
|---|---|---|
| EvolocumabAlso: RepathaPatients will receive evolocumab 420 mg administered subcutaneously | Drug | evolocumab 420mg |
| PlaceboPatients will receive placebo administered subcutaneously | Drug | placebo |
Primary outcome
Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
Time frame: Baseline and after 30 days of treatment
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).
3 secondary outcomes
Change in ADP-unstimulated P-selectin Expression
Time frame: Baseline and after 30 days of treatment
Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)
Time frame: Baseline and after 30 days of treatment
Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI
Time frame: Baseline and after 30 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab in people with Diabetes Mellitus, Type 2 and Dyslipidemia Associated With Type II Diabetes Mellitus, run by Inova Health Care Services at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 19 Jan 2023. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 19 Jan 2023). 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 Adenosine Diphosphate (ADP) Stimulated P-selectin Expression (time frame: Baseline and after 30 days of treatment). 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 19 Jan 2023.