Phase 4Recruiting
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)
Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)
- Sponsor
- Duke University (Academic or other)
- Enrolment
- 6,000 planned
- Conditions
- Percutaneous Coronary Intervention; Peripheral Endovascular Intervention
- Interventions
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL; Normal Saline (Placebo)
- Ages
- adults, older adults
- Registry
- NCT06909565
From the registry
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.
Primary outcomes
- Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization
- Total number of major adverse limb events (MALE) after endovascular revascularization