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โ† Trials
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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

RecruitingPhase 4Ages 18 Years - anyAllDuke University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Males or females โ‰ฅ 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 Criteria: * 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
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What it tests

  • Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
  • Normal Saline (Placebo)
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Where

147 sites
Advanced Cardiovascular LLC
Alexander City, United States
Cardiology, PC
Birmingham, United States
Heart Center Research, LLC
Huntsville, United States
IMS Cardiology
Avondale, United States
Cardiology Associates Research Group
Jonesboro, United States
Arkansas Cardiology
Little Rock, United States
Arkansas Heart Hospital
Little Rock, United States
Pacific Oaks Medical Group
Beverly Hills, United States

โ€ฆand 139 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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