Percutaneous Coronary Intervention study: Inclisiran sodium
Official title Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
ClinicalTrials.gov ID: NCT06909565
What this study is testing
What is Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL?
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for percutaneous coronary intervention.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see whether inclisiran can reduce major heart and limb events in people who have had coronary or peripheral artery revascularization.
- Who it's for
- Adults who have recently undergone percutaneous coronary intervention or peripheral endovascular intervention and are at high risk for cardiovascular events.
- What's involved
- Participants will receive subcutaneous inclisiran injections twice a year, along with their usual statin therapy, and will have regular follow‑up visits and tests to monitor heart and limb health.
- Time commitment
- The study lasts about two years, with participants having scheduled visits and injections every six months.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention
You likely can't join if
- 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...
- Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety...
See the full 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
The study team makes the final eligibility decision.
Where it is enrolling
- Alexander City, Alabama, United States
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Avondale, Arizona, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Chula Vista, California, United States
- Concord, California, United States
- Glendora, California, United States
- Newport Beach, California, United States
- Northridge, California, United States
- Riverside, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Van Nuys, California, United States
- Ventura, California, United States
- West Hills, California, United States
- Aurora, Colorado, United States
+ 110 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Alexander City, Alabama, United States; Birmingham, Alabama, United States; Huntsville, Alabama, United States; Avondale, Arizona, United States; Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States and 124 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.