RECRUITING

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

Description

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.

Conditions

Percutaneous Coronary InterventionPeripheral Endovascular Intervention
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Related Conditions:

Percutaneous Coronary InterventionPeripheral Endovascular Intervention

Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Percutaneous Coronary Intervention
Intervention / Treatment

-

Contacts and Locations

Beverly Hills

Pacific Oaks Medical Group, Beverly Hills, California, United States, 90211

Newport Beach

Radin Cardiovascular Medical Group, Inc, Newport Beach, California, United States, 92663

Bridgewater

Advanced Heart Care LLC, Bridgewater, New Jersey, United States, 08807

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Schuyler Jones, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

2029-12