Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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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

1. the effect of evolocumab therapy on platelet activation and reactivity;
2. the effect of evolocumab on biomarkers of platelet activation and inflammation.

Eligible patients will be randomized prior to start the PCI equally to either:

1. 420 mg evolocumab ; or
2. 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

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Diabetes Mellitus, Type 2 Dyslipidemia Associated With Type II Diabetes Mellitus Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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evolocumab 420mg

75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.

Group Type ACTIVE_COMPARATOR

Evolocumab

Intervention Type DRUG

Patients will receive evolocumab 420 mg administered subcutaneously

placebo

75 subjects on optimal statin therapy undergoing elective PCI will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive placebo administered subcutaneously

Interventions

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Evolocumab

Patients will receive evolocumab 420 mg administered subcutaneously

Intervention Type DRUG

Placebo

Patients will receive placebo administered subcutaneously

Intervention Type DRUG

Other Intervention Names

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Repatha

Eligibility Criteria

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Inclusion Criteria

* Diabetes Mellitus
* Dyslipidemia
* Undergoing elective PCI

Exclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No