RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 final visit for each participant in the study.

Official Title

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

Quick Facts

Study Start:2025-06-04
Study Completion:2029-10-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07000357

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets one of the following:
  2. 1. Participants with history of an ASCVD event: Participants ≥ 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 ≥ 60 mg/dL (≥ 1.55 mmol/L).
  3. * T2DM requiring ongoing medical therapy
  4. * Age ≥ 65 years
  5. * Previous above ankle amputation due to PAD
  6. * Previous diagnosis of non-end stage CKD
  7. 2. 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) and diagnostic evidence of at least one of the following disease categories (i, ii, or iii):
  8. 1. CKD with eGFR ≤ xx mL/min/1.73 m2
  9. 2. Current tobacco use
  10. 3. Age ≥ 65
  11. 4. T2DM (if included on the less significant atherosclerosis criterion iii)
  12. * Participant should be receiving a maximally tolerated lipid-lowering regimen including a maximally tolerated dose of a statin.
  13. 1. Participants who are judged by the treating physician not to tolerate high-intensity statins (according to guidelines, typically, atorvastatin ≥ 40 mg once daily or rosuvastatin ≥ 20 mg once daily) may be included if treated with a low or moderate intensity statin dose.
  14. 2. Participants not receiving any statins must have documented intolerable side effects to at least 2 different statins, including one at the lowest standard dose or on a chronic medication that would prohibit the use of a statin (according to the prescribing information for the statin in question).
  15. 3. Participants must achieve a stable dose (\> 28 days) of lipid-lowering therapies before screening.
  1. * 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.
  2. * Any revascularisation procedure planned within the next 3 months.
  3. * Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.
  4. * Calculated eGFR \< 15 mL /min/1.73 m2
  5. * Any laboratory values with the following deviations at screening:
  6. * AST or ALT \> 3 × ULN
  7. * TBL \> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN)
  8. * Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L).
  9. * Creatine kinase \> 5 × ULN
  10. * Urine albumin/creatinine ratio ≥ 500 mg/g
  11. * Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.
  12. * 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.
  13. * Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.
  14. * Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.
  15. * 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.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Fairhope, Alabama, 36532
United States
Research Site
Foley, Alabama, 36535
United States
Research Site
Mobile, Alabama, 36608
United States
Research Site
Saraland, Alabama, 36571
United States
Research Site
Gilbert, Arizona, 85296
United States
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Glendale, Arizona, 85308
United States
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Mesa, Arizona, 85206
United States
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Phoenix, Arizona, 85014
United States
Research Site
Phoenix, Arizona, 85051
United States
Research Site
Phoenix, Arizona, 85053
United States
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Scottsdale, Arizona, 85260
United States
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Tucson, Arizona, 85715
United States
Research Site
Tucson, Arizona, 85741
United States
Research Site
Tucson, Arizona, 85745
United States
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Beverly Hills, California, 90211
United States
Research Site
Canoga Park, California, 91303
United States
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Castroville, California, 95012
United States
Research Site
Chula Vista, California, 91911
United States
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Fountain Valley, California, 92708
United States
Research Site
Garden Grove, California, 92844
United States
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Lake Forest, California, 92630
United States
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Lancaster, California, 93534
United States
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Loma Linda, California, 92350
United States
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Los Angeles, California, 90017
United States
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Lynwood, California, 90262
United States
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Newport Beach, California, 92663
United States
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Norco, California, 92860
United States
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Northridge, California, 91325
United States
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Poway, California, 92064
United States
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San Diego, California, 92111
United States
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San Dimas, California, 91773
United States
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Thousand Oaks, California, 91360
United States
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Stamford, Connecticut, 06905
United States
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Waterbury, Connecticut, 06708
United States
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Crystal River, Florida, 34429
United States
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DeLand, Florida, 32720
United States
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Fort Lauderdale, Florida, 33308
United States
Research Site
Fort Lauderdale, Florida, 33316
United States
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Hallandale Beach, Florida, 33009
United States
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Hialeah, Florida, 33012
United States
Research Site
Hialeah, Florida, 33012
United States
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Immokalee, Florida, 34142
United States
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Inverness, Florida, 34452
United States
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Jacksonville, Florida, 32204
United States
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Jacksonville, Florida, 32216
United States
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Lake City, Florida, 32055
United States
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Longwood, Florida, 32750
United States
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Maitland, Florida, 32751
United States
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Miami Lakes, Florida, 33016
United States
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Miami, Florida, 33176
United States
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New Port Richey, Florida, 34652
United States
Research Site
New Port Richey, Florida, 34653
United States
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Orlando, Florida, 32801
United States
Research Site
Orlando, Florida, 32807
United States
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Orlando, Florida, 32825
United States
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Palm Harbor, Florida, 34684
United States
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Palmetto Bay, Florida, 33157
United States
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Pembroke Pines, Florida, 33029
United States
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Port Charlotte, Florida, 33952
United States
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Winter Haven, Florida, 33880
United States
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Atlanta, Georgia, 30328
United States
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Atlanta, Georgia, 30342
United States
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Canton, Georgia, 30114
United States
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Decatur, Georgia, 30033
United States
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Hinesville, Georgia, 31313
United States
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Macon, Georgia, 31210
United States
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Peachtree Corners, Georgia, 30092
United States
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Riverdale, Georgia, 30274
United States
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Tucker, Georgia, 30084
United States
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Union City, Georgia, 30291
United States
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Chicago, Illinois, 60607
United States
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Winfield, Illinois, 60190
United States
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Carmel, Indiana, 46290
United States
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Evansville, Indiana, 47714
United States
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Evansville, Indiana, 47715
United States
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Ames, Iowa, 50010
United States
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Bowling Green, Kentucky, 42101
United States
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Lexington, Kentucky, 40503
United States
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Owensboro, Kentucky, 42301
United States
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Versailles, Kentucky, 40383
United States
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Bossier City, Louisiana, 71111
United States
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Hammond, Louisiana, 70403
United States
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Lake Charles, Louisiana, 70601
United States
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Shreveport, Louisiana, 71105
United States
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Bangor, Maine, 04401
United States
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Scarborough, Maine, 04074
United States
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Annapolis, Maryland, 21401
United States
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Baltimore, Maryland, 21229
United States
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Oxon Hill, Maryland, 20745
United States
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Pikesville, Maryland, 21208
United States
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Duluth, Minnesota, 55805
United States
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Maplewood, Minnesota, 55109
United States
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Saint Cloud, Minnesota, 56303
United States
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Bridgeton, Missouri, 63044
United States
Research Site
Jefferson City, Missouri, 65109
United States
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Kansas City, Missouri, 64128
United States
Research Site
Kansas City, Missouri, 64151
United States
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Springfield, Missouri, 65807
United States
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Missoula, Montana, 59808
United States
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Elkhorn, Nebraska, 68022
United States
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Fremont, Nebraska, 68025
United States
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Omaha, Nebraska, 68144
United States
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Las Vegas, Nevada, 89102
United States
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Las Vegas, Nevada, 89119
United States
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Somerset, New Jersey, 08873
United States
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Bronx, New York, 10451
United States
Research Site
Brooklyn, New York, 11221
United States
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Buffalo, New York, 14217
United States
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Durham, North Carolina, 27701
United States
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Greensboro, North Carolina, 27408
United States
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Monroe, North Carolina, 28112
United States
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Morehead City, North Carolina, 28557
United States
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Morganton, North Carolina, 28655
United States
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New Bern, North Carolina, 28562
United States
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Wilmington, North Carolina, 28401
United States
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Winston-Salem, North Carolina, 27157
United States
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Fargo, North Dakota, 58104
United States
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Columbus, Ohio, 43213
United States
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Dublin, Ohio, 43016
United States
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Lima, Ohio, 45805
United States
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Norman, Oklahoma, 73069
United States
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Portland, Oregon, 97210
United States
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Camp Hill, Pennsylvania, 17011
United States
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Horsham, Pennsylvania, 19044
United States
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Philadelphia, Pennsylvania, 19114
United States
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Smithfield, Pennsylvania, 15478
United States
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Wilkes-Barre, Pennsylvania, 18711
United States
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Charleston, South Carolina, 29402
United States
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North Charleston, South Carolina, 29405
United States
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North Charleston, South Carolina, 29406
United States
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Rapid City, South Dakota, 57701
United States
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Chattanooga, Tennessee, 37404
United States
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Chattanooga, Tennessee, 37421
United States
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Knoxville, Tennessee, 37849
United States
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Knoxville, Tennessee, 37912
United States
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Knoxville, Tennessee, 37938
United States
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Memphis, Tennessee, 38119
United States
Research Site
Memphis, Tennessee, 38128
United States
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Tullahoma, Tennessee, 37388
United States
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Beaumont, Texas, 77706
United States
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Brownsville, Texas, 78526
United States
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Corpus Christi, Texas, 78404
United States
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El Paso, Texas, 79902
United States
Research Site
El Paso, Texas, 79905
United States
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Euless, Texas, 76040
United States
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Houston, Texas, 77002
United States
Research Site
Houston, Texas, 77034
United States
Research Site
Houston, Texas, 77043
United States
Research Site
Houston, Texas, 77087
United States
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Humble, Texas, 77338
United States
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Katy, Texas, 77450
United States
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Kingwood, Texas, 77345
United States
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Mesquite, Texas, 75149
United States
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Paris, Texas, 75462
United States
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Pearland, Texas, 77584
United States
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Pharr, Texas, 78577
United States
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Plano, Texas, 75093
United States
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San Antonio, Texas, 78207
United States
Research Site
Sugar Land, Texas, 77478
United States
Research Site
Sugar Land, Texas, 77479
United States
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Tyler, Texas, 75701
United States
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Victoria, Texas, 77901
United States
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Bountiful, Utah, 84010
United States
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Ogden, Utah, 84404
United States
Research Site
Ogden, Utah, 84405
United States
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Salt Lake City, Utah, 84124
United States
Research Site
Salt Lake City, Utah, 84148
United States
Research Site
Charlottesville, Virginia, 22911
United States
Research Site
Falls Church, Virginia, 22042
United States
Research Site
Manassas, Virginia, 20110
United States
Research Site
Norfolk, Virginia, 23504
United States
Research Site
Richmond, Virginia, 23219
United States
Research Site
Suffolk, Virginia, 23435
United States
Research Site
Redmond, Washington, 98052
United States
Research Site
Seattle, Washington, 98122
United States
Research Site
Morgantown, West Virginia, 26505
United States
Research Site
Kenosha, Wisconsin, 53144
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-04
Study Completion Date2029-10-24

Study Record Updates

Study Start Date2025-06-04
Study Completion Date2029-10-24

Terms related to this study

Keywords Provided by Researchers

  • Atherosclerotic Cardiovascular Disease

Additional Relevant MeSH Terms

  • Cardiovascular Disease