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

ConditionsPercutaneous Coronary InterventionPeripheral Endovascular Intervention
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

    Drug

    300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; \& every 6 months thereafter

  • Normal Saline (Placebo)

    Drug

    Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter

Treatment groups

6,000 Participants
are divided into 2 treatment groups
Group A: Inclisiran SodiumActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization

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

Time frame
From randomization to first occurrence of MACE (up to approximately 4 years)
2

Total number of major adverse limb events (MALE) after endovascular revascularization

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

Time frame
From randomization to first occurrence of MALE (up to approximately 4 years)

Secondary outcomes

1

Number of participants with cardiovascular (CV) death

Time frame
From randomization to CV death (up to approximately 4 years)
2

Number of participants with all cause death

Time frame
From randomization to all cause death (up to approximately 4 years)
3

Number of participants with venous thromboembolic events (VTE)

Time frame
From randomization to first VTE (up to approximately 4 years)

Other outcomes

Sponsors and contacts

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Duke University

Lead sponsor

Novartis Pharmaceuticals

Collaborator

Colorado Prevention Center

Collaborator

Mount Sinai Hospital, New York

Collaborator

Source ClinicalTrials.gov
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