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NCT06909565RECRUITINGIRB Ready

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)

Sponsored by Duke University

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 6000 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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 s

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

6000 participants

โšง

Gender

ALL

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Sponsor

Duke University

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Alexander City

Alabama

Location available
View Alexander City location page
RECRUITING

Huntsville

Alabama

Location available
View Huntsville location page
RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Beverly Hills

California

Location available
View Beverly Hills location page
RECRUITING

Covina

California

Location available
View Covina location page
RECRUITING

Newport Beach

California

Location available
View Newport Beach location page
RECRUITING

Northridge

California

Location available
View Northridge location page
RECRUITING

Van Nuys

California

Location available
View Van Nuys location page
RECRUITING

West Hills

California

Location available
View West Hills location page

๐Ÿ“ And 41 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Heart Disease Treatment in Beverly Hills?

Join others in California exploring innovative treatment options through clinical research

Heart Disease Treatment Options in Beverly Hills, California

If you're searching for Heart Disease treatment in Beverly Hills, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Beverly Hills, Newport Beach, Bridgewater and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Heart Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 6000 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Heart Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Heart Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Heart Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06909565. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.