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Inclisiran for Preventing Heart and Limb Problems After Procedures

This study is looking at whether inclisiran can help prevent serious heart problems (major adverse cardiovascular events or MACE) and serious leg/foot problems (major adverse limb events or MALE) in people who have recently had a procedure to open blocked arteries in their heart (percutaneous coronary intervention or PCI) or legs (peripheral endovascular intervention or PVI). Inclisiran is a medication given as a shot under the skin every six months, after an initial dose and a follow-up dose at 3 months. It's already approved to lower cholesterol. You might be able to join if you are 18 or older and had a successful PCI or PVI within the last 14 days. The study aims to enroll about 6000 people and is currently recruiting.

Study design
This is a randomized, double-blind study where you would either receive inclisiran or a placebo (normal saline) injection. About 6000 participants will be enrolled.
What's involved
You would receive injections on Day 0, Day 90, and then every 6 months thereafter. The study will follow you for up to approximately 4 years.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to approximately 4 years to track any major adverse cardiovascular or limb events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06909565

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

Recruiting
PHASE4Ages 18+InterventionalPrevention
Duke University
~6,000 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mLNormal Saline (Placebo)

At a glance

Recruiting sites
132 of 136 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization
Measured over From randomization to first occurrence of MACE (up to approximately 4 years)
+1 more outcome measured

Conditions

Percutaneous Coronary Intervention
Peripheral Endovascular Intervention

Explore related trials

Coronary Artery DiseasePeripheral Artery Disease

Where it's being run

136 sites across 36 states
California14
Florida13
Texas12
North Carolina9
New York8
Maryland6
New Jersey6
Pennsylvania6

Study leadership

  • Schuyler Jones, MD · PRINCIPAL_INVESTIGATOR · Duke Clinical Research Institute
  • Marc Bonaca, MD · PRINCIPAL_INVESTIGATOR · Colorado Prevention Center
  • Roxana Mehran, MD · STUDY_CHAIR · Mt Sinai
  • Manesh Patel, MD · STUDY_CHAIR · Duke University

Who to contact

Robin Barron-Nelson, RN, MSN
[email protected]
321-946-2747
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Signed informed consent must be obtained prior to participation in the study.
Males or females ≥ 18 years of age
Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD
Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention

Exclusion

Planned future PCI or PVI
Current or planned use of an open-label PCSK9 inhibitor during the study
Any prior treatment with inclisiran
Active or planned participation in another clinical study involving investigational drugs or devices during the study
Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results
Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities
Patients taking prohibited therapies as listed in Section 6.6.3
Pregnant or breast-feeding women

What this trial measures

  • Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularizationFrom randomization to first occurrence of MACE (up to approximately 4 years)

    MACEs include CHD death, non-fatal MI, ischemic stroke, ALI, major (above the ankle) amputation of vascular etiology, clinically driven coronary and limb revascularization.

  • Total number of major adverse limb events (MALE) after endovascular revascularizationFrom randomization to first occurrence of MALE (up to approximately 4 years)

    MALEs consist of ALI, major amputation of vascular etiology, clinically driven lower extremity peripheral revascularization.