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

Conditions

• Percutaneous Coronary Intervention
• Peripheral Endovascular Intervention

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jul 23, 2025

Status verified

Jul 2025

Primary completion

Oct 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

6,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Inclisiran Sodium
  Inclisiran sodium 300 mg subcutaneous injection
• Placebo Comparator: Placebo
  Normal saline 1.5 ml subcutaneous injection

Primary Outcome Measure

Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization [ Time Frame: From randomization to first occurrence of MACE (up to approximately 4 years) ]

Central Contacts

• Robin Barron-Nelson, RN, MSN
  321-946-2747
  [email protected]
• Jen Holt
  +1 919 824 6334
  [email protected]

Locations (102)

Find similar trials in Alexander City, AL

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