Study which will compare the platelet activity in patients with coronary heart disease who have either PCSK9i therapy on top of high effective lipid lowering therapy or highly effective high-dose statins. The Platelet activity will be investigated in the fasting state and in the nonfasting state after a defined lipid load.

Pilot Study: The LIPL-PLATELET Study LIPid paneLs And PLATELET activity in coronary heart disease - LIPL-PLATELET

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003483-12-AT

Enrollment

Registered

2017-10-04

Start date

2018-06-28

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the platelet activity in patients with coronary heart disease

Interventions

Trade Name: Praluent Product Name: Praluent Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • ability to give informed consent • age = 18 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • age 600 × 109 cells/l) • patients with known platelet disorder • history of alcohol or drug addiction • patients currently on oral anticoagulation • inability to give informed consent • pregnancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to investigate changes in lipid variables and platelet function between a fasting and a defined non-fasting state in stable patients with CAD by statins alone or statins plus alirocumab.;Secondary Objective: not applicable;Primary end point(s): the platelet activity in patients with coronary heart disease under different lipid lowering therapy;Timepoint(s) of evaluation of this end point: Platelet activity will be evalueted from every blood assessment. In patients with PCSK9i - 6 times 3 blood draw during the Visit 1 (baseline blood draw, blood draw 3 and 5 hours after oral fat loading) and 3 blood draws during the Visit 1a (baseline blood draw, blood draw 3 and 5 hours after oral fat loading) In patients with highly effective high dose statins - 3 times during the Visit 1 (baseline blood draw, blood draw 3 and 5 hours after oral fat loading)	—

Measure

Time frame

Main Objective: The aim of the study is to investigate changes in lipid variables and platelet function between a fasting and a defined non-fasting state in stable patients with CAD by statins alone or statins plus alirocumab.;Secondary Objective: not applicable;Primary end point(s): the platelet activity in patients with coronary heart disease under different lipid lowering therapy;Timepoint(s) of evaluation of this end point: Platelet activity will be evalueted from every blood assessment. In patients with PCSK9i - 6 times 3 blood draw during the Visit 1 (baseline blood draw, blood draw 3 and 5 hours after oral fat loading) and 3 blood draws during the Visit 1a (baseline blood draw, blood draw 3 and 5 hours after oral fat loading) In patients with highly effective high dose statins - 3 times during the Visit 1 (baseline blood draw, blood draw 3 and 5 hours after oral fat loading)

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactATVB

Verein zur Fördferung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB)

004315863737

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026