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NCT07000357RECRUITINGIRB Ready

A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event

(AZURE-Outcomes)

Sponsored by AstraZeneca

Quick Self-Assessment

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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

The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD).

Who Can Participate

Inclusion Criteria

Meets one of the following: 1. Participants with history of an ASCVD event: Participants โ‰ฅ 18 years of age at the time of signing the ICF with a history of ASCVD defined as ACS within 1 to 12 months prior to randomisation, or large artery ischaemic stroke suspected to be due to atherosclerotic vascular disease within 1 to 12 months prior to randomisation, or revascularisation for symptomatic lower limb PAD, and LDL-C โ‰ฅ 60 mg/dL (โ‰ฅ 1.55 mmol/L). Additional risk factors based on the level of the screening LDL-C: o Participants with an LDL-C โ‰ฅ 75 mg/dL (โ‰ฅ 1.9 mmol/L) need to have at least one of the other additional risk factors below.
T2DM requiring ongoing medical therapy
Age โ‰ฅ 65 years
Previous above ankle amputation due to PAD
Previous diagnosis of non-end stage CKD 2. Participants at increased risk of a first ASCVD event: Male participant โ‰ฅ 50 years of age or female participant โ‰ฅ 55 years of age at the time of signin

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

15100 participants

โšง

Gender

ALL

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Sponsor

AstraZeneca

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Fairhope

Alabama

Location available
View Fairhope location page
RECRUITING

Foley

Alabama

Location available
View Foley location page
RECRUITING

Huntsville

Alabama

Location available
View Huntsville location page
RECRUITING

Mobile

Alabama

Location available
View Mobile location page
RECRUITING

Saraland

Alabama

Location available
View Saraland location page
RECRUITING

Vestavia Hills

Alabama

Location available
View Vestavia Hills location page
RECRUITING

Gilbert

Arizona

Location available
View Gilbert location page
RECRUITING

Glendale

Arizona

Location available
View Glendale location page

๐Ÿ“ And 273 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 Cardiovascular Disease Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Cardiovascular Disease Treatment Options in Birmingham, Alabama

If you're searching for Cardiovascular Disease treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Fairhope, Foley 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 Cardiovascular Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 15100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Cardiovascular 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 Cardiovascular 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 Cardiovascular 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: NCT07000357. 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.