Is NCT07000357 recruiting in Fairhope, AL?

Yes, NCT07000357 is currently recruiting participants at its Fairhope, AL location. This cardiovascular disease clinical trial is actively enrolling qualified participants.

How do I join the cardiovascular disease clinical trial in Fairhope?

To join this clinical trial in Fairhope, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Fairhope clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cardiovascular Disease Clinical Trial in Fairhope, AL

About This Cardiovascular Disease Study in Fairhope

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). The Study Closure Visit will be scheduled to occur after the PACD and will be the

Sponsor: AstraZeneca

Who Can Participate

Inclusion Criteria

Meets one of the following:

Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening Additional risk factors based on the level of the LDL-C and timing of MI or stroke: o Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one of the other additional risk factors (i to viii) below. ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD

Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii): (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:

Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin/creatinine ratio ≥ 30 mg/g) and/or persistent eGFR \< 60 mL/min/1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening

Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist

Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist

ABI \< 0.9 or \> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance For (ii) and (iii), participants need to have at least one of the additional risk factors below:

CKD with eGFR x mL/min/1.73 m2

Current tobacco use

T2DM (if included on the less significant atherosclerosis criterion iii)

Participants should receive a background lipid lowering regimen anticipated to achieve at least a \~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid). Participants must achieve a stable background lipid lowering therapy \> 28 days before screening.

Exclusion Criteria

Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.

Any revascularisation procedure planned within the next 3 months.

Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.

Calculated eGFR \< 15 mL /min/1.73 m2 at screening.

Any laboratory values with the following deviations at screening:

AST or ALT \> 3 × ULN

TBL \> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN)

Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L).

Creatine kinase \> 5 × ULN

Urine albumin/creatinine ratio ≥ 500 mg/g

Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.

Inadequately treated hypothyroidism defined as TSH \> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.

Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.

Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.

Use of PCSK9 inhibitors: evolocumab/alirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Fairhope?

Yes, this clinical trial (NCT07000357) has an active research site in Fairhope, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Cardiovascular Disease Treatment Options in Fairhope, AL

If you're searching for cardiovascular disease treatment options in Fairhope, AL, this clinical trial (NCT07000357) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Fairhope research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced cardiovascular disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cardiovascular disease clinical trials near you to find additional studies recruiting in your area.

Cardiovascular Disease Clinical Trial in Fairhope, AL

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