NCT03331666

Impact of LDL-cholesterol Lowering on Platelet Activation

Terminated Phase 4 Results posted Last updated 1 April 2021

What this trial tests

Phase 4 trial testing Evolocumab in Familial Hypercholesterolemia in 4 participants. Terminated before completion.

Timeline

16 November 2018

Primary endpoint
4 February 2020

4 February 2020

Quick facts

Lead sponsor	Columbia University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	4
Start date	16 November 2018
Primary completion	4 February 2020
Estimated completion	4 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Evolocumab (EVOLOCUMAB) — full drug profile →

Conditions studied

• Familial Hypercholesterolemia — all drugs for Familial Hypercholesterolemia →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Familial Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (P2Y12 Reaction Units (PRU)) Primary · Day 7, Day 14, Day 21, Day 28, Day 84

ADP- or arachidonic acid-stimulated platelet aggregation as assessed by the commercially-available VerifyNow P2Y12 (VerifyNow PRUTest) will be performed. Unit: PRU

P2Y12 Test, Day 7

Group	Value	95% CI
Evolocumab	266
Placebo	216

P2Y12 Test, Day 14

Group	Value	95% CI
Evolocumab	268
Placebo	226

P2Y12 test, Day 21

Group	Value	95% CI
Evolocumab	268
Placebo	233

P2Y12 Test, Day 28

Group	Value	95% CI
Evolocumab	276
Placebo	225

P2Y12 Test, Day 84

Group	Value	95% CI
Evolocumab	256
Placebo	267

Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (Aspirin Reaction Unit (ARU)) Primary · Day 7, Day 14, Day 21, Day 28, Day 84

ADP- or arachidonic acid-stimulated platelet aggregation as assessed by the commercially-available VerifyNow Aspirin assay (Accriva Diagnostics) will be performed. Unit: Aspirin Reaction Unit (ARU)

Aspirin Test, Day 7

Group	Value	95% CI
Evolocumab	521
Placebo	432

Aspirin Test Day 14

Group	Value	95% CI
Evolocumab	608
Placebo	401

Aspirin Test, Day 21

Group	Value	95% CI
Evolocumab	533
Placebo	490

Aspirin Test, Day 28

Group	Value	95% CI
Evolocumab	530
Placebo	512

Aspirin Test, Day 84

Group	Value	95% CI
Evolocumab	406
Placebo	386

Sponsor's own description

The primary goal is to assess the impact of Evolocumab therapy on platelet function of familial hypercholesterolemia (FH) patients in a randomized, double blind study. Evolocumab is a humanized monoclonal antibody that targets circulating PCSK9, increases hepatic LDL receptor, decreases plasma LDL cholesterol and reduces risk of cardiovascular events. Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.

The secondary goal is to determine if platelet activation or the response to Evolocumab therapy is modified by rs3184504 polymorphism. The investigators believe that these investigations will complement ongoing studies to demonstrate that Evolocumab reduces athero-thrombotic risk and aid the decision-making as to whether Evolocumab can reduce the atherothrombotic risk in acute coronary syndrome (ACS) patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.